Medtronic Aktie

Okay. Welcome to Orchestra BioMed's R&D Day 2026. Welcome to those of you who are not in this beautiful room in a rainy day in New York, and thank you for your patience in the rainy day in New York, caused us to do some things that's critical to our business, which is adapt and be flexible and solve problems. So we have done that. So we have a great program today. My name is David Hochman. I'm the Chairman and CEO and one of the founders of Orchestra BioMed. And I will also be your Emcee.

Hopefully, this works. It works. But I'm not seeing that.

Okay. So today is really focused on R&D, but we do have some fabulous recent updates that I'm going to take a moment just to talk about. We are -- I'm proud to say, funded through 2028, following a very successful oversubscribed public offering that we completed last week. We have some new shareholders in the room. We welcome you guys to the Orchestra BioMed family. We had great support from existing shareholders and we're super grateful that the $80-plus million in net proceeds from that financing combined with over $100 million we had at the end of the quarter have us funded to execute on almost everything we're going to talk about today.

That includes having just accomplished the enrollment completion of our BACKBEAT pivotal trial, 349 enrolled patients, and we're now really focused on the follow-up. We'll talk about that.

We also learned something really important just this week from the FDA. We confirm something we thought, which is that we'll be able to -- our partners at Medtronic will be able to submit this as a PMA supplement. And we are excited about the acceleration of the Virtue trial, which is going to be actually our first topic today, and that's happening real time having just come from [ DCT ] and having an investigators meeting or coordinators meeting. We really have some great momentum there.

So what we're looking ahead at is 2 years of very significant milestones. We just completed one in terms of enrollment of BACKBEAT. We're looking forward to seeing the primary end point results, which hopefully will present as a late breaker at [ HRS ] in May of 2027. There is long-term follow-up after that, but exciting regulatory milestones that Medtronic will be able to drive in terms of submission, leading to what we think can be commercialization as early as the first half of 2028 in the United States. And the second half of that year could see global commercialization.

At the same time, we're going to be focused on enrolling the Virtue trial, our target is the end of next year, 12-month follow-up on that study. So a rich landscape of catalysts and milestones. But today, as we talked about, is about R&D, not the business. If you're here, hopefully, you may already be a shareholder, that you've heard about our business model, you've heard about the arrangements we have in terms of what we can do together with Medtronic. But we really want to focus on the science and the clinical research that has driven these programs.

So we have a great program. We made some adjustments. We're going to start actually with the deep dive into Virtue SAB with [ Dr. Allen Jeremias ]. Darren is going to lead that program. We're then going to do a deep dive with [ IVIg ] Ready and Marathon into the [ ABM ] program.

Unfortunately, we had Dean [ Allen Jeremias ], one of our co-principal investigators were supposed to be with us and unfortunately, is not going to be able to be with us today. But we do have another bonus contributor who is a senior clinical adviser to orchestrate [ Duane Pinto ], [ Duane ] is the Chief Medical Officer, one of the most exciting private companies in structural cardiology, [ Yanaval ]. And he's spending a little time on the side, advising us, and we're really grateful that he'll be here and contributing as well.

I'm going to do this without knowing what's behind because this keeps bouncing. So R&D. R&D really starts with unmet needs. And we happen to be focused on and we're going to dive into specifically how we're focused on helping tackle two of the biggest medical problems there are in the world. hypertension, which is the #1 contributing risk factor for death worldwide and coronary artery disease, which is the leading cause of death.

But we have a particular approach to R&D that I want to discuss. And they're consistent across both our programs. What we first focus on is building on proven foundations. And what you'll see with both of our technologies is we are building on two of the fundamental technologies that have created the field of interventional cardiology and cardiac rhythm management.

With regard to Virtue balloon angioplasty with regard to AIM, the pacemaker. These are technologies that have been clinical use for upwards of 50 years.

What we focus on doing that is creating powerful new capabilities to add to these proven technologies. And so what we're doing with AVIM is allowing a pacemaker now to be a potent way to immediately and substantially lower blood pressure and treat hypertensive heart disease.

With Virtue, we think we are creating a better superior approach to delivering , extending the release and tissue of a proven drug that will help heal the vessel.

And the key to what we do is collaboration. We are realizing the potential of these technologies through collaboration, both with our strategic partners as well as with our research partners.

So I was here about 2 years ago. Maybe some of you were here. We did -- it was a smaller, less well-attended R&D day event. And it was right when we were getting going with the BACKBEAT Trial. And one of the things I talked about 2 years ago is in the sort of a great room when you look at the art, you can't see it online, the renaissance that is occurring in the use of these foundational technologies, balloon angioplasty and pacemakers. And the Renaissance is a beautiful thing when we look back in time to essentially innovate for the future.

And so that's happening with these foundational technologies. So someone may want to look at this. It's going in and out. Fortunately, I think I know what I'm talking about.

So I think we go back with a pacemaker to 1958. We have our colleagues from Medtronic here. I'm going to make them stand up in a minute. But 1958 was the first implant of a pacemaker, for ballon angioplasty the first procedure in 1977. Pacemakers are still a fundamental technology. Balloon angioplasty is foundational to everything we do in interventional cardiology exciting new things are happening.

In pacing conduction system pacing is really changing the way we think about cardiac pacing therapy and creating a rich fertile landscape for new treatments like AVIM and leading, which actually Medtronic brought first to the market 10 years ago, is entering a very exciting stage of dual chamber devices. And actually, we'll talk a little bit about how a single device, dual chamber pacemaker can synergize with our therapy.

On the balloon side, we're seeing a renaissance in balloon angioplasty with drug-coated balloons. So it's renaissance is setting the stage for something.

Now what did the renaissance at the stage for in history. Around 15th, 16th century. We had all this looking back to the classics to be able to innovate for the future. Well, the Renaissance gate birth is something I love, a period in history, or the age of enlightenment. So we've now moved from the last R&D day to the age of Enlighten it 2 years later, okay? And in that period saw the innovations in the Renaissance, essentially turning to broader and more significant impact in society where that invention really spread, both through geography and through different parts of society.

In the age of enlightenment, the scientific discoveries, things like Copernicus putting the sun at the middle of our solar system became with Galileo, the birth of astronomy and other sciences. We have the printing press, which suddenly now we can express information everywhere. So we see the same theme, okay?

Well, we see our technologies enlightening the renaissance that's occurring around the foundation. And with AVIM, we're talking about taking cardiac pacing into a whole new area. Being able to envision treating hypertension and hypertensive heart disease at the same time as we treat bradycardia, allowing the same device for the same patient to have more impact while also opening up the potential to treat more patients.

And the same with Virtue, we're taking proven technology, both the procedure and the drug and now creating a much better way, in our view, to make that available to tissue, both in the artery and eventually beyond. And we think ultimately improve vessel healing, and improve the clinical outcomes for patients. So these are big ideas.

Now something else happened in the enlightenment. It was a creation of the Symphony Orchestra. And that too was driven by innovation. And by visionary leadership. So it was about new instruments, new training for musicians, new ways of being able to teach music and actually no take music, new ways of thinking about putting groups of musicians together.

But then there was this guy in Monteverdi, if you're a student of classical music and I'm a real amateur. They had this idea of how do I take all of these innovations and bring them together to allow music that we've never heard before, essentially music at a whole another level but be able to transport that music from city to city. From Royal courts eventually to music hall so everyone could enjoy it.

And so the thing about that Symphony Orchestra that inspired us is the idea of extraordinary collaboration. I'm going to have to turn to read because it's one of my favorite quotes now I'm going to see it. What more miraculous creation of mankind is there than the Symphony Orchestra, 100 musicians collaborating flawlessly in the creation of a single [ seniority ], from moment to moment. We tend to take for granted the skill and sensitivity of such a performing organism. And we should take time to marvel a fresh as such a joint effort as possible for human beings so rich in communication, beauty and meaning.

So a Symphony Orchestra is really a collection of extraordinary talented people, the best people in their field, but coming together and supplementing their individuality to create something beautiful together. We are not called orchestra by accident. We're called Orchestra because that is what it takes to bring these type of innovations to reality and to patients.

Our Orchestra looks a little different. We are -- as I say over 100 people in Orchestra today, working across R&D, both on the device side as well as on the pharma side. You may think of us as a device company, but core to the technology we're going to talk about first is true innovation in how do you protect a drug that works wonderfully in the body for extended release and focal delivery.

We have phenomenal people now in our clinical operation, our field clinical operation that have driven the BACKBEAT Trial and are driving the Virtue trial and cutting across that are other skill sets from marketing skill sets, regulatory and finance, I'm incredibly proud of the organization that we've built.

This organization then partners with amazing physicians. We have some with us today, amazing research staff, and we frankly see our patients. We underestimate the patients we are seeking to treat are a partner in the innovations that we are bringing forward. We have 349 that are part of the BACKBEAT Trial, but a lot more that wanted to be and hope to be part of the trial. And we have an ambition to bring another 740 patients into our Virtue trial.

And then core and lastly, to our business is a focus on strategic partnerships with world-leading companies that allow us to think about how we're going to optimize bringing these technologies to patients globally.

We have our partners from Medtronic, [ Dr. Rob Cow, Chris King, Matt Schuld ] from Medtronic here, it is because of that partnership that what you're going to learn about with AVIM. And unbelievably quickly, when you think about in the scale of treating and changing medicine, become a reality, assuming we get the data that we hope to see out of the trial. It's that collaboration allows us focus on being what best and what we need to be best at, innovation, clinical execution, thinking about how to bring together a small company like Orchestra with a global leader like Medtronic and leveraging what they have built over the last many decades that makes them the leader in this field.

So with that in mind, I have now the privilege to introduce a person without which any of this would be -- wouldn't have been possible. my business partner, my co-founder, the President and Chief Operating Officer of Orchestra, who has been core to the development of both these technologies from the concept stage. And that's Darren Sherman. He's going to lead us through a deep dive with Dr. Allen [ Jeremias ] into the Virtue technology I'll come back for our discussion, and then we'll get back to the AVIM program. So thank you guys so much.

It is incredibly great to be on the stage and talking to you. I am tone deaf and know nothing about music. But the Orchestra is really important to me because it is about the collaboration of the people and finding ways to get together. And so following David is an honor and a privilege, and we wouldn't be here today together for a long time.

But I want to talk to you about Virtue. And Virtue is truly a great name for this product, and it's been where we're going with it. But to do that effectively, we have to kind of maybe go backwards in time. And we got to talk a little bit about the history of interventional cardiology and the treatment of coronary are disease specifically.

And it really starts in 1977 with balloon angioplasty, the first treatment that could be nonsurgical treatment to open up arteries and prevent cracking, Amazing, great, great for patients. Not perfect. Restenosis rates or reinventing rates were high. And sometimes, patients would come back and physicians didn't love the idea that they come back with a block closure or a sudden closure of the vessels.

The innovation of thinking I can put a permanent metal implant once your artery comes next because I can solve two things with that. I can prop that artery open, prevents abrupt closure, reliably walk away and not worry too much as the case and reduce the rate of reintervention a little bit.

In 2003, with the launch of the first drug-eluting sense, it takes it to another level. The drug is not there to treat the disease. The drug is there to treat the injury of the stenting and the angioplasty and it dramatically changes medicine for the last 2 decades with millions of patients benefiting from that. What it really did was provide a source for the drug to get into the tissue, limit proliferation of cells and allow patients to reduce that first year restenosis rates.

Unfortunately, you signed up for a lifetime of having a stent. Both a bare metal stent and a drug link stent is a lifetime of having a foreign [indiscernible] body, which 2% to 3% to 4% year-over-year risk, not just the reintervention but of MI stroke and death.

We dramatically change things to improve, and we traded it off with that permanent implant. Today in the last 2 years is the first entry of drug-coated balloons. It's going backwards to go forward. It's relying on the first balloons, but taking those drugs from those drug-eluting stents and delivering them to the tissue from the surface of that balloon. And remarkably, we don't need it because a rep closure hasn't been seen with these drug-coated balloons in thousands of patients, including clinical trials. Because pharmacotherapy changed over the last 30 years.

So if you don't need the scaffold to prevent restenosis, if you don't need a scaffold to prevent a block closure, you're really relying on the scaffold for drug delivery. With new drug-coated balloons, we're trying to deliver the same drugs we use in stents. But without that permanent implant there to continually provide a source of that drug to the tissue. It's tricky.

Okay I'm getting yelled I'm too wide. You can't see the screen. Thanks, David. Thanks, Matt. This drug-coated balloon evolution is really getting exciting here now. Why? Because the first drug coated balloons in the U.S. got approved about 2 years ago. And at CCT, half of the content on the PCI track is only about drug-coated balloons. And right now, in the first year since launch, about 25,000 patients or 1/4 of all instant restenosis cases in the U.S. already had in the first year.

And but 1/3 of cases happened for non-IFR cases, not the indication, but for clinical need. Drug-coated balloons have been available outside the United States in pretty much every geography for more than a decade, and we're the last to come to market from it because FDA was so concerned about how much drug where does it go? Is it creating downstream particulate. Can reproduce be produced a challenge.

But the excitement level is high and rightly so. Can we move on to an era of leave nothing behind. And do we really need to put more metal in.

Going to Renaissance and Enlighten. We're here with Virtue taking two key pillars: balloon angioplasty, 1977, and the use of an [ mTOR inhibitor seroma oraclomycin ] dating back to the first clinical uses in 1983. The drug itself could questionably be the most studied drug. If you go to clinicaltrials.gov and you do a search, it is amazing how many places and what it's done. But what's not happened with it is no one's really develop a long-acting version of it. It's always systemically delivered or it's delivered from a stent, which provides a depot, a long-term permanent depot.

Virtue is taking this concept, which is a revolutionized interventional cardiology, a different direction. A stent is a surface delivery where the drug has to diffuse out of the stent and the fuse through the tissue. A drug-coated balloon delivers the drug to the intraluminal surface and has to diffuse from the surface into the tissue.

I am not a strong human, when I go to the dentist, I'm not going for the topical lidocaine. I'm going for the injection. Why are the drug injections of lidocaine and why is the topical not good enough? Because it's really difficult to get a topical to get a high enough dose for long enough. And infusion is what's required. That is what we're doing with Virtue SAB.

It's the first of its kind novel approach to deliver transmural infusion of these drug particles. These drug particles are not uniform in size. They immediately saturate the vessel small particles proximately and more closely to the intralumen, the largest stick there, smaller ones go through, but importantly, with a large liquid volume, we're able to distribute into the vessel wall and beyond the vessel wall circumferentially and longitude on the vessel. If we use drug-eluting stents as a marker, they deliver over about 28 days, 1 nanogram per milligram tissue. That's a drug concentration in the tissue through diffusing from this permanent implants.

We're delivering a tenfold dose instantaneously and maintaining the tenfold dose over the lotion period. We're doing an injection into the bustle wall itself or the vessel as an infusion, not a diffusive topical delivery. Here's a short animation, giving you a little bit more about Virtue for those that aren't familiar. If you guys could run that, please?

So the balloon was in as a normal balloon. It has micro poor in a balloon. The balloon digital to the lesion without rushing. And as it gets the lesion, you use the drug itself to inflate the balloon and it comes through the micropores of the balloon. These particles, these small particles travel through the balloon, into the tissue, surround it and distribute along it.

But importantly, these particles now become the source of diffusion of the drug. Not from the surface, but inside the vessel wall itself. In the inner side of the vessel wall and throughout the vessel wall.

So this is not a drug-coated balloon, and this is not a drug-liking stent, but it's foundationally based on a balloon and a drug that works. This is not a new technology. It's a brand-new technology because we're leveraging the past. We know this drug works. There's not a binary risk of us this drug works in this indication. It's in millions of patients.

It's not a question of that. It's a question of, can you mimic what a stent does without a stent, can you deliver high enough dose for long enough? No one has been able to do that, and that's what Virtue does. So if we think about this, the particle and the drug formulation is the innovation. It's the ability to create a long-acting so a long-acting [ MTOR inhibitor ] that you can deliver locally and focally.

The balloon is the familiar, it's allowing the interventional cardiologist to use something familiar to put in injections with sell. It's one version of delivering an injection, not a syringe or another device. It's an example of delivering a local acting into where you want it to go.

But think of all the applications where you wish you could have a long-acting tour, where [ MTORs ] already been either studied or approved by systemically dosing or long-term dosing, but they can't get high enough doses for long enough locally.

That's what we're doing here in this trial, not the third or fourth drug-coated balloon, the first infusion of a long-acting drug. And the innovation is the drug itself, the pharmaceutical component and it gets to leverage a really big history where this drug has been studied.

We're now enrolling this trial. 740 patients. And it's a one-to-one randomization versus Boston Scientific's agent drug-coated balloon, the market leader and the first drug approved in the United States. But it's more than a 1:1 with agent because it's comparing [ sirolimus to paclitaxel ]. We'll talk about that difference and it's big. It's not just comparing [ sirolimus to paclitaxel ], It's comparing surface delivery a topical to a long-acting infusion. We're enrolling these patients looking for a 12-month target lesion failure follow-up, looking both as noninferiority with a test for superiority.

With this, I'd like to introduce Dr. Allen [ Jeremias ]. He is a special person who's come to us, thankfully to join the orchestra. He is here because he's an expert in physiology, an expert in imaging, a thought leader on how to improve complex PCI. But he's got to mind that thinks differently and wants to understand differently. Not that he blindly believes, he wants the question ask just like we do.

He's been recognized by his peers and Sky and CRF as a top interventionalist. But to me, he's an example of people that join our team, a good human being a hardworking person, who I had the pleasure of talking to almost daily since we've been engaged in this. That's special, and I want to thank you for being here today and it gets the pleasure of trying to touch slides on a screen that you can't read.

David, thanks so much. So I like to get this somewhat interesting. I know it might be a little dry. You're talking a lot of cardiology, interventional cardiology, but let's see how we get through this.

So The original or the main indication really only on-label indication, if you will, currently for this technology is instant restenosis, right? And instant restenosis is not a small problem. We do about 1 million PCIs currently in the U.S. alone. About 10% -- a little over 10% of patients come back year after year after year with instant restenosis. So that's obviously a pretty substantial number of patients. When you think about how many stents are landed in this country loans with 1.6 million a year.

And what happens is that when you come back with instant restenosis and you already have a failed stent, right? There's a reason why this then failed. Now you are faced with the option, are you going to put another layer of stent you're going to continue that path, if you will, or you do something else. And I think since we have the drug-coated balloons available for maybe over 2 years in the U.S., as Darren mentioned, Boston Scientific agent balloon was the first approved. We now have a second one. Obviously, this has been now kind of the default therapy.

But that said, these patients don't do great. But if you have a stand failure, your chances of coming back is actually pretty substantial over the next 4, 5 years.

And even when you're looking at the de novo group, even those patients don't do great, right? Because you have this permanent implant. And so this whole mindset now that we have the technology available in Interventional Cardiology has shifted more towards what can we do for lifetime management, not to get out of the room today to get the patient off the table. How can we have this patient for the next decade, 2 decades, 3 decades as we all probably going to age to a lot longer than previously. And so not leaving something behind is a very appealing concept.

Let's talk about the two major drugs that are out there on coated balloons. One, we talked about sirolimus. The other one is paclitaxel. And so we had this history before about 20 years ago when the drug-eluting stents came first long. And so we had two drug-eluting stents. And for a couple of years, they will about use 50-50, right? But then over time, we discovered that sirolimus to a much, much better drug.

When you're looking at the left, you see that there's a much lower risk of target lesion realization. Overall, major adverse cardiac events are reduced by about 25 plus 26% with sirolimus compared to paclitaxel. And so when you're looking at, I guess, history, what happened was that pack total really fell off the cliff, right? Nobody is putting this on the stand any longer now that we have better technology available. And so currently, in the market, every single drug loading extend is coated with sirolimus.

And one of the main reasons is that, let's just be plain paclitaxel is just cytotoxic, right? And so the therapeutic window you have is very, very narrow with that versus all of us, is cytostatic, obviously, a big, big difference. It's just a resting smooth muscle cell proliferation, which basically means we're creating injury when we do angioplasty. It just goes with the territory. There's no way of not kind of tiering the tissue apart, if you will, to a certain extent. And so the body reacts with proliferating with muscle cells. That's kind of the normal response, which is what the Achilles he was for interventional cardiology, the time before we had the drug-eluting stents.

And so it's important, obviously, to arrest and also modulate inflammation. A lot of diseases are inflammation modulated. But in particular, when you introduce an injury to the vessel, of course, you have a huge inflammation response.

And so having a broad therapeutic window, having potent anti-inflammatory response, I think those are the main advantages of using sirolimus. That said, the major disadvantage is, it is very, very difficult to get it into the tissue. Because it turns out paclitaxel. It's actually is lipophilic. So it's actually easy to build up a balloon and just get the paclitaxel into the tissue versus aromas you have to do a lot of modeling, which is these guys worked on it for a decade to 2 decades.

Too long, let's just say it was too long, whatever, how long it takes, right? But they develop something incredible, and sometimes it takes time to build something special. But the bottom line is if you just put zeros on the balloon, none of it will penetrate into the tissue. That's really the problem.

And I think we have a very, very interesting example, kind of a natural experiment, if you will, which is an old stand the Endeavor stent, which since fell out of favor, it was a Medtronic stent at the time. It has been now replaced with the [ Endeavor Resolute ]. And so the interesting thing about it is that Resolute, which is the current stent that we use, uses the same drug. It's the same stent. The only difference is the polymer, right? The polymer of the original endeavor just released all of this were in the first couple of weeks or so. And it just was not a high enough tissue concentration for long enough to basically inhibit this response we just talked about versus the current polymer, of course, is much, much better.

And as you see all the way on the right, it has now released of sirolimus up to 180 days. And so the difference is on the right in terms of the outcomes. When you're looking at instant sirolimus or target lesion failure, it is substantially higher with the original endeavors then compared to the current technology. So that's kind of the proof of principle how important it is to have sufficient tissue concentration of salons in the tissue to inhibit this inflammatory response.

And so one of the things we know about the current generation drug-coated balloons is that there's just only so much me you can put on a bagel. You just can't put more than the big holding. And so that's the fundamental limitation when you have a balloon, right? You put as much on as you can, but there's only so much surface. And to make things worse, it's sitting on the outside, right? It's not inflated, but still sitting on the outside. And you can imagine getting it to where you need to go, sometimes it's not easy. Sometimes you have to cross to atrocity, sometimes you have calcifications. And so it's not necessarily that it's easy to get the balloon. And so in some studies up to 80% of the drug was lost in transit. And so when you only have so much surface to put drug on and a lot of it is lost in transit how much do you actually have to deliver?

And then what happens is that the delivery is uneven because in some areas of the balloon, maybe some of the drug was shaved off. And so you're going to have less delivery in one area. In other areas, you might have a bit more -- and it's a topical, just like Darren said, like ligand cream. So even when there is drug available, only so much penetrates into the tissue.

And so the consequence, this is basically the drug concentration in the tissue. So let me get back to the slides that I think Darren showed before. And this is a very, very important thing to remember. You don't have to be a biologist, but kind of -- but remember this one thing that if you want to have potent inhibition of the inflammatory case post PCI, you have to achieve a minimum of one nanogram of drug in the tissue per milligram of tissue for at least 30 days, better even for 90 days.

And this is an algorithmic scale, right? So when you're looking at the current generation sirolimus alluding DCBs, which is Magic Touch and solution, you see the drug concentration at 30 days is much, much lower than this 1 nanogram benchmark. Stents are around 1 nanogram, right?

And so when you're looking at the outcomes of the clinical trials, this is the SOLUTION trial, the event rate was 16%. And which is, I guess, noninferior to standard of care, which is what the trial showed but ultimately, certainly not a result that we would be happy with [indiscernible].

And so now having fundamentally different approach to drug delivery to actually being able to deliver a large liquid volume of infusion and getting the tissue concentration to much, much higher levels really changes the ballgame here and to have this sustained release of sirolimus is obviously critical. And I want to show you a couple of more slides in a minute in terms of the binding sites, how we literally overwhelm the binding science for sirolimus and completely saturated, which is actually shown here on the bottom right. you see a drug-eluting stent minds about 1/3 of the sites or so. Virtue SAB has a tissue concentration of 13 nanograms another logarithmic scale above the drug-eluting stents. And as you see, it fully saturates the serous binding sites.

And so this kind of delivery mechanism, the mechanism is actually very, very important and crucial. And it matters also or the main feature actually is the size of the particles right? So sirolimus itself cannot get into the tissue. So you have to have some delivery mechanism, but we're not now talking about nanotechnology, right? These particles are a magnitude smaller than we currently have on the current DCBs, which has made the micrograms.

So what we have available right now is the micrograms this is this is nanograms. So obviously, it's another magnitude smaller. And so it allows much deeper tissue penetration. So it's not just about how much drug we deliver, but also the size of the particles. And interestingly enough, even though all of this is nanotechnology, there's still differences in particle sizes. And so the larger particles kind of stay at the site of the injury in the [ subentimal ] area. But then the tiny little particles, if you will, they actually travel longitudinally, which is really important because now we can not just cover the area where we ballot, but also a little bit longer. And I'm going to show you some examples from some of the data that we have, how that makes it impact on the actual angiogram.

This is what I was talking about before. So when you look at the right designs is the leading drug-eluting stent -- sorry, to the Medtronic folks. I shouldn't have said that. And it basically delivers what we ask it to do, right? So early on in the first few days, you get up to 10 nanograms per milligram is concentration at 30 days and up to 90 days, it stays around 1. So it delivers what we actually need although, again, we have obviously some instant restenosis even in those stents. But we're looking at the left with Virtue SAB, you can see now early on, it goes up to 100 and then later on to about 10. And this is where it stays up to 30 days, and then it reaches out to 90 days at those concentrations as well. So the magnitude higher in terms of the tissue concentration of sirolimus.

And this is the data that we currently have upon which the current trial has been based. It's called the [ SABRE ] trial. It was done in Europe in 50 patients, multiple sites, multiple countries, as you see here. There was an independent core lab and DSMB adjudicating all of these cases and evaluating these cases. And there was a primary safety endpoint at 30 days and then a mandatory angiographic follow-up at 6 months, which is important in many trials because, as you probably know, when you come back for an angiogram even the patient might be asymptomatic when you see a restenosis, you might treat it. And so trials that have mandatory rep angiograms at 6 months or 1 year have usually higher event rates than those that have only clinical follow-up.

So this is the trial results. On the left, you have intention to treat, which basically includes the entire population. And as you see, target lesion failure all the way on the right is 12%, right, which actually is very, very good. again, with the angiographic follow-up that was mandated.

And then almost incredible between here 1 and year 3, there were virtually no additional events, right. At the 3-year event rate was 14%. On the right is the protocol number. And so 36 of those patients that were enrolled the protocol actually was followed, which means that there was no valuation of the exclusion or inclusion criteria. The procedure was done properly and so forth.

So among patients who fulfilled all the criteria of the trial and the procedure was done correctly, when you're looking now at target vision failure of 2.8%, and 3 years is 5.6%, really numbers that are unheard of. And this is now a trial that is about a decade old. So the technologies are also not the same in terms of the vessel prep, which also is particularly important, right?

I think in the future, when we hopefully come to where we're not going to letting behind. The vessel prep is going to be as important as the drug that we deliver. So those will be the two elements that kind of determine your long-term prognosis. But that said, in this case, even with the techniques we had a decade ago, the outcomes on the per protocol basis are really incredible.

And when you compare that to the agent on the DCB trial, all the way on the right, the target lesion failure at 3 year was 32%, obviously vastly different from the trial results of the SABRE trial. And so these are some of the cases that we studied that we learned about.

So this is on the left right coronary artery. if you've seen an androgen before, there is pretty significant in [indiscernible] stenosis up to 80%, 90%. In the middle, this is post treatment. So this is vessel prep and also delivery of the drug via the Virtue SAB. And then the 6-month follow-up. And you can see that if anything, the vessel is bigger, right? What we're looking at here is LL's late lumen loss but that's an angiographic core lab measure. Normally, what happens is that we implant the stent, let's just say the patient comes back 6 months later and there is some degree of internal hyperplasia. So there's some degree of lumen loss. And so that's what lumen loss is. And so that's how it's measured in the core lab. In this case, as you see, it's subtle, but it's a negative number.

Which means the luminal is larger than we left it behind after the initial procedure, which is kind of unheard phenomenon, if you will. This is another example of a mid LED, again, tight stenosis up to 90% in the mid LED post lesion prep, actually, it's a very, very good angiographic result.

You see post Virtue, it might look actually a little bit worse than immediately have to prep, which is interesting, right? And the reason why we think this happens is that this is actually the drug infusion into the tissue, right? So there's a little bit of haziness as you infuse this drug. But then at 6 months follow-up, look at how incredible this looks. And not only that, when you're looking at all the little side branches, those are the septal branches coming off the LED, there is a lot more blood flow in the entire tissue.

And both proximal and distal to the treatment site, it seems like the vessel also pumped up, right, as to the concept that some of those nanoparticles distribute alongside the vessel.

And then the last case, I'm going to show you basically source the same thing. Again, as the notes in the mid LED, then you see all the way on the right, the 6-month follow-up. Again, a negative late bloom and loss number, the vessel actually grew over time. So based on those results and everything else, we explained, we're actually very excited to now be in the enrolling phase of the Virtue ISR pivotal trial.

As Darren mentioned, a total of 740 patients will be randomized to either virtue or agent paclitaxel with a primary endpoint of target lesion failure at 12 months, there's no mandatory angiogram, obviously, in this case.

And the analysis is interesting. It's a noninferiority study, right? So first, we want to sure we're not inferior to agent, of course. But if we meet non-inferiority criteria, we move into a superiority testing. And we're obviously optimistic that we can show for this particular device to priority over the current standard of care and then patients we have followed out to 5 years.

This is the summary. So Virtue SAB is really the first of its kind in terms of having been able, for the first time, to have a large liquid infusion of sirolimus into the tissue. It saturates virtually 100% of the binding signs, unlike even with current drug-leading stent technology. It has sustained sirolimus' release over up to 90 days. and we are moving into the clinical trial, as mentioned and will hopefully be able to get some data in a couple of years. All right, guys. Thank you very much.

Thank you. Absolutely by now. We're going to have a little round table discussion here. We're going to take questions at the end. I want to remind everyone, we have this QR code. We got to turn that mic up. So we will take questions at the end. We're going to have a little discussion here. Darren is going to kick off.

So I guess [indiscernible] [ Allen ], I think the first real question here is the world has seen DCBs and had it for a while, the [indiscernible] today is going on like what's really led to that? Why is drug-coated ballon? And why is this topic? And why is it on everyone's thought process today in the U.S. and is it just U.S.-centric or what's really driving DCB as a category right now?

I'm intervention [indiscernible] cardiologist also and I'm the Chief Medical Officer of [indiscernible]. But Allen and I the same hospital. So perhaps we have the same strategies. But expense were the best that we had. And that's no longer the case we see the downside of those devices, which are as instant restenosis, which Allen went through beautifully and stem thrombosis, which is a life-threatening illness.

These are man-made diseases. So if we don't have to leave something behind in order to avoid so that's a better mousetrap. So we're actually behind in the United States compared with Europe because they had it before us. So we were kind of with envy seeing what was happening there and all the new strategies that were being pursued with regard to repair and coronary arteries.

So we're catching up now. And I think that's the exuberance that you see, and that's the off-label use also that you have seen because we've seen what things are capable of outside the United States.

Even beyond the potential complications of stents, I think this concept of caging the vessel and inhibiting vasomotion because it's a biologically active thing. It's not just a pipe, right? The vessel actually is a biologically active thing. So it has endothelium, the endothelial function is important at oxide causes vasodilatation. And so all of these things are important, and we inhibit this basically for a lifetime, right, especially in the younger person living with the 10, 30, 40 years. I think that's a problem. And also, what we have learned is that you develop recurrent disease.

So there's a reason why you have the stenosis in a particular point in your artery. And so if you live long enough 5 years, 10 years, 15 years, you're going to develop recurrent plaque. And it's not the sense fault that you have plaque buildup, but you're just going to have plaque most likely or very likely in the same spot. And now coming to the lab, it makes our life much more difficult because now treating this disease where you have not just plaid but also kind of a tech vessel with a stent. [indiscernible] is the options, I would say. And so I think this is kind of almost a revolution in a sense, right, that we -- you showed the slide about 1/3 of patients have got DCBs for non-indicated patients, which is outside of [indiscernible] stenosis.

I don't want to take over the moderator role, but I just want to ask Allen one question is because -- and you mentioned and I thought it was important is you've kind of described how currently optimizing PCI is different than it was in, say, 1990 when perhaps the stent was highly optimized, but the reason why drug-eluting balloons are perhaps more likely to succeed and are going to succeed -- what's your thoughts?

Yes, two reasons. I think one is the prep we have better understanding of how to treat a vessel without actually putting a stent and most importantly, medical therapy, right? Because the main issue we had in the early days of angioplasty basin coming back in the middle of the night with a closed vessel, I think with the current anti-beta therapies that we have and everything else that we do, that's very, very unlikely. And in fact, there's two large randomized trials now for de novo DCB and it has not been seen at all.

I personally sorry. on just my own take here, but I find it fascinating that this groundswell of improvement is in the face of data showing that the first year restenosis rates of drug colon is actually worse than a stent. So you're really playing off and putting a worst first year therapy and to avoid the long term. Those choices every day, right? And honestly I obviously will realize that, right, because we can read all the numbers although we doctors. These guys are the numbers.

But in many cases, if not most cases, we now make the decision that we accept a little bit of a higher vessel target vessel failure, meaning they're coming back with recurrent restenosis but we don't put a second layer on because putting a second layer, even more than the first year. And now coming back, we're really out of options.

Sorry, I you'd agree that -- we're still in the early days of truly getting to drug got balloons. You can't -- I don't think you're satisfied with the results today. I think people are looking for improvement, right? And there's a real? And so it's not like, oh, I'm coming with another one. It's we need to grow and build on what we have and make it better. I think that's a key thing?

Yes. I mean I think you see the appetite for a better. I mean we'll take an early penalty to not leave something behind because we've reduced the options of patient by putting a stent in. So them coming back, and then we decide what to do is a better choice.

Now if we had something that wasn't worse in the first year, that's home run.

That was going to -- I remember our first meeting Allen, we obviously spent a lot of time together. But I think as you've now not just understood our technology better, but now have the opportunity to treat patients with it.

What do you see is that? And what's the expectations you have for a technology like this. And what excites you about it and to Dwayne's point in terms of thinking about a future where we can build on this leave nothing behind concept, but with a better technology. What are the advantages that you're seeing? And what are you hopeful in terms of the Virtue trial?

Well, I mean, based on all the data, we just went over nobody can predict the future. But obviously, we're optimistic that this is going to be a complete van changer in terms of the recurrent restenosis or even in de novo disease. And it will fundamentally shift how we treat patients.

If we have this available, and we, let's say, we get a decent vessel prep, which happens in about 80%, 85% of patients. So let's say, there are still some patients where you need a scaffold, right? But in the vast majority of cases, where the vessel prep is adequate, -- and now you have a technology like this where you can deliver industrial doses of sirolimus into the vessel and completely block the inflammatory response, it's a complete gain gene.

In terms of not getting adequate drug delivery or adequate treatment in terms of treating particular coronary i[indiscernible] restenosis, I think what are the downsides? What happens if we don't really get adequate coverage. We don't get adequate healing. I think it would be good to bring to light some of the challenges that we see in terms of treating essentially a recent stent if we aren't getting that drug effect.

Well, I mean if we can't inhibit this process and we create a lot of interims. So treating instant restenosis is actually difficult, right? Because there's again the reason why this stent failed. And now we go in with big devices. We go with higher atmospheres. Sometimes we use intravascular. Sometimes we use laser, we use different devices. So we introduced a lot of injury in the vessel to now basically clean out as much of that tissue as possible and open the stent as much as we can. And so based on that, you need some drug coverage, otherwise, you're going to have recurring restenosis.

I mean I want to make two points that are related to what Allen just said is it's much more difficult, much more expensive to treat some of the U.S. instant recent notes period. But also most important to me as a physician are the curves that were shown that major adverse events when you have restenosis are higher.

So 30% of these people are presenting the heart attacks. So we're giving them a disease prevent a heart attack, and we're giving them a more chance of having a heart attack. That's not a good trade for me.

So we've taken somebody whose major problem was angina. I might not have ever turned into a heart attack now we've given them a risk to have hard tech. So I'm not good with that trade. I want to have helping patients in the long term.

I'd like to take -- we talk about dose. We talk about dose concentration. You showed what I think are remarkable images that core labs have reviewed and seeing not just the lesion improve, but seeing the vessel improve and seeing [ septales ] and side branches grow and it is ultimately about perfusing the heart and making sure it [indiscernible].

Is that a normal thing you've seen? I mean, like slated to Holiday Inn, that's not mole right? Like do you guys see this? And what do you -- what does it mean by having an infusion that could go beyond the edges? And what could that mean?

Yes. So that's a good point. What happens frequently. So the longer you spend is, of course, the higher anions. So frequently, what happens these days is that people come back that have long stands 2, 3 stents and a good portion of the set of which you might only treat partially in a sense because the DCBs are on a cost per bit are very, very expensive, right? They're up 10x, more than 10x more than a stent. And so you're using a balloon, let's just say, your drug-coated limit is currently available. that is 30 million units long. Now we have a $40 million balloon coming out.

But there is certainly areas to be behind, right? The edges in particular are not fully covered. And so these are all areas where there is a good chance that might have recurrent restenosis. So having a technology like this, for example, where you not only have high tissue concentration where you actually inflate the balloon. But with these nano particles, we talked about that also longitude distributes in the vessel you might indirect, they actually also treat this entire segment. And I think this is what you were referring to when you're reviewing these angiograms from the SABRE trial. That this entire segment looks not just the lesion itself, but the entire segment looks better, looks bigger the branches are better confused and so forth.

I don't want to scare you guys when it comes to describing how angioplasty and stents are done, but I'm just going to do it anyway, is when we're faced with the blockage, we inflate a balloon first and [indiscernible] open. And then we put a stent in hoping that we landed in the same area we just injured. So that's what Allen is talking about, if you miss, that's called geographic miss.

They missed them to me.

Well, when we were doing cases together, how the state of the art was? What do you think? Yes, that's what you think.

What do you think? Did we get the spot to run we're like probably 2x0 is still 0. But still we both agreed. And that's why people come back with [ edge ] restenosis is because we didn't cover there. You don't have to worry about that with Virtue because when -- and you do have to worry about it with a drug-eluting balloon because it's just like right there. But if you can get the whole segment, then you indemnify yourself against did you get it? And that way, we can also not have to choose between leaving a 10% lesion behind and we cover that with a longer stent. Because it's just a math equation. Do you put in a longer stand with more [indiscernible] stenosis? Or do you leave a plaque behind that you think might not never get there. But if you can treat the whole thing, then I think that's a better mousetrap.

I just want to comment because one of the things that, in addition to drug-coated balloons being private the most prolific topic of TCT, you guys are both imaging experts. We're getting better tools for intravascular imaging. We're getting amazing tools for noninvasive imaging. So some of the things that used to happen I think is going to be a lot more evident as we move into the next 10, 20 years of treating artery disease. Did we do a good job?

And so we're particularly excited about having a tool that hopefully has that broader reach to that deeper drug delivery and has that effect, particularly since the tools we're going to be able to use to actually see the underlying disease and see the results after getting better and better.

For me, the satisfaction, the curiosity of the interest in this is really about not just preventing cell proliferation, which paclitaxel because shown that it can do. But really getting inflammatory responses beyond it.

If you think of improving the vessel caliber beyond where the lesion site you treat it is, it's unlikely that's proliferative. It's more likely that anti-inflammatory upstream in downstream as a physiologist and as a scientist, that's fascinating.

Yes, because we don't have anything like that. And we do know from the legs, that outflow is important for disease progression approximately. So we something like that. Allen, you should comment, but we haven't had something like that, that can improve the outflow stents without having to put another stand, we've just have been tracked.

So what I think what's exciting about this technology altogether is that we're just scratching the surface with this trial we're doing for instant restenosis. But when you really sit down for 5 minutes and think about all the potential applications for this, right, which is peripheral disease and other -- not just the heart, obviously. And how many diseases we have are inflammatory in nature?

And if you find other ways to deliver this, you could treat what else can you do there with us.

You can dream. Well, we have some new money we're going to carefully put it to work. But I think one of the things about that, that's interesting is we are not constrained to Darren's point, by even though we built on the foundation of the familiar, we're giving physicians a tool of essentially a plain balloon that can convert in the procedure to a drug infusion balloon. And that was difficult to develop as a first generation, it's going to be a great product.

But the idea to what you're pointing out of being able to optimize a delivery system for each application, even beyond in the artery, one of the things we aspire to with some of our next-generation devices. Can you treat multiple lesions without having to bring the device out. And when we think about other places in the body, we can go so much of either your post intervention is managing the healing response, which is what this sirolimus formulation line can potentially do.

And then there's primary indications. I just had -- I have tendonitis in two different places in my right holder. So I had two deep injections of steroids. They working, [indiscernible] pain. But if you think about all the people that have -- raise your hand in this room if you've had a steroid injection somewhere in your body, okay?

So eventually, in some places, you can only have 2 or 3 because it brings to break down the connective tissue. It doesn't always work. can we get sirolimus in play in an indication like that as an application we've thought of. By the way, that doesn't need to be a fancy device. That can be the off-the-shelf tools that we have. So we do have a lot of ideas we are focused on, as we said, execution of the trial that balance the PI want...

The genius is not the balloon with the holes in it, the genius is, I guess, the formulation.

It is on is, let's say. The pharma team we have in Orchestra BioMed we're really proud. I mean any IDS basically anything that ends in It is something that we look -- that would say is good.

As somebody who's spent my whole life thinking about innovation and creating new products. It's so much more satisfying to build on the strength of clinical and science of somebody else. This is not a new drug. And it's not a new drug that hasn't been studied lots of places. It's just a drug that hasn't been able to be delivered focally and stay there long enough.

It's not the binary risk of is this drug good or bad or is it safe or not. It's can you deliver it where you want it to go for long enough. It just so happens that, that's what we're doing here in this trial. And just the beginning.

So we're going to pause here. We'll take a break. I think we'll give everyone a chance in the room. If you need to use the restore which something will come back in 10 minutes and get started on the AVIM Therapy program. Once again, if you have questions, we're going to come back at the end with our physician speakers and we're going to address as many questions as we can. Thanks so much. We'll take a 10-minute break.

[Break]

Take a seat so we can keep going here. Thanks so much.

Well, we have -- we keep adapt keep adapting. Okay. technology. We'll acknowledge for a moment that there's some cool things happen in the world, other lighting things happen in the world, like maybe the biggest IPO in history in AI we have used AI thoughtfully to help build this presentation. We use it all the time, but I just want to remind everyone, treating the body is still a very direct thing and actually running trial and clinical research is all about humans, engaging humans, right? AI will be powerful. But technology, sometimes as your friend today, it has not been our friend, okay?

So we're going to get back to our program. So I'm excited to kick off our deeper dive into atrioventricular interval modulation therapy. And we're going to talk about the unmet needs associated with our target patient population in hypertension.

But I'm going to put this slide up from my dear friend, [ John Salvesen ]. Because John got us thinking about the idea hypertension is the of the tree, and this is a baobab tree of hypertension, right? It is the trunk of the tree of all cardiovascular disease.

So when we think about the problem with high blood pressure and particularly the population that we're targeting older comorbid patients, we have to realize that just living life feeds, high blood pressure, which feeds everything having to do with cardiovascular disease from heart attack to stroke to coronary artery disease to the development of heart failure all the way through impairment of your eyes and your kidneys.

And this is really the #1 problem in the world in terms of healthcare because it affects over 1.4 billion patients. It is a difficult condition to manage because it is ultimately not just a lifestyle disease, but it is a maladaptive part of us living longer.

Unfortunately, we all have to look forward to the challenges with managing blood pressure, and it contributes to a lot of morbidity and a lot of mortality.

This is particularly true we think about the launch population for the therapy that [ Vivek and Marat ] are going to give you further insights into. And when you think about the context of our partnership with Medtronic. Because the launch population here is patients that already need the device, whereby we can deliver our therapy.

And in that patient population, for 1 million patients worldwide are going to get a pacemaker this year, next year that also have hypertension. They're older. We're going to dive into that population. They have comorbidities. But once again, they already need the intervention.

And our partner -- our amazing partner, Medtronic, is the dominant global leader. That didn't happen by accident. [ Earl Bakken ], founded Medtronic around this technology. And so the idea that the data we'll see shortly at the submission that's going to be made shortly there effort is going to then be done by Medtronic, and we'll talk more about how this is already built on a new platform device. It is not simple, but we are working hard to bring this to fruition with our partners is quite exciting.

It's also exciting when we think about where we can go next because our vision is to bring this therapy and that technology, not just to the pacemaker population, but to patients that really are a lot like pretty much the same profile from an age comorbidity and health standpoint, but they don't yet need a pacemaker.

And we have a breakthrough designation for both the first population and the second population, but it's really important when you think about the mechanism of the data that we're going to go through to realize that it tells the story not just about how to help patients that need a pacemaker, but potentially how to help patients that can get that device to benefit from AVIM Therapy. We're doing a lot of work with Medtronic. We're doing work on our dig into and learn more about how physicians feel about that expansion opportunity, how patients feel about that.

And so while that works unfolding, I want to share one insight that we thought was pretty powerful. Which is we went with a third-party group to a group of these patients. Patients that are older patients that have significant controlled hypertension that isn't well managed with meds, patients that have had prior MI, prior stroke and asked them, would they be interested to get an implanted device to benefit from this therapy. We don't have the pivotal data yet. And we were struck by the fact that 70% of those patients, it's a small sample, 64, but that's actually significant. You get some statistics out of that, so they were willing and so we are excited about the broader opportunity. And with that, I'm even more excited to introduce, and I'm going to get to introduce both Dr. Vivek [indiscernible] and [ Dr. Marat Fudim ].

It's important that we have, I think, one of the most prominent influential electrophysiologists here with us. And Vivek has been instrumental to the development of cutting-edge technology, all field ablation left atrial enter, but device technology, both transvenous and leadless pacemakers and conduction in pacing. And he is the Executive Chairman of our Steering Committee. He's been an adviser to the company. And so I'm excited to introduce him, but also after him, [ Dr. Marat Fudim ].

Importantly, in Murat, we have a leading heart failure expert and a physician who brings together clinical cardiology, translational medicine and insights into how we better treat heart failure, both our failure with reserve, but more importantly, in relevant heart failure preserved ejection fraction.

It is exciting to have both of these guys here because more than anything else, they are almost everywhere. They are -- they were at TCT. They're at HRS. They are highly sought after by small companies like us and equally by big companies like Medtronic because they can bring together thoughts on new therapy and how that can be translated through clinical trials to [ Houston ] patients. So I'm going to hit it to you, Vivek. Thanks so much, and we'll come back together for a similar discussion in the Q&A.

Okay. Thank you. So let's see it this week it's not working here. Yes. I'll depot Okay. So my charge is to discuss AVIM Therapy and try to, I guess, explain to you why I'm so enthusiastic about it. I think there's going to be a major new therapy that's going to be benefiting as you've already heard, a potentially very large population.

So if you look at traditional pacing -- and one of the interesting aspects of this technology is, it's not a new device. We're not talking about a new widget here. It's actually fundamentally just a new way of pacing through existing pacemakers. And I think that's very exciting, obviously, in terms of implementation and clinical practice, it will be relatively seamless.

You know about pacemakers. There's traditional pacemakers, as you see here, the very first Medtronic pacemaker to, let's say, the ones we're using today, both the conventional pacemaker with regular leads as well as the leadless pacemakers, which potentially even supercharge this therapy, we may talk about that later.

So to concur with this, there's also been advances in conduction system pace. And that's probably relevant for us. I don't know if we want to spend too much time talking about it. One of the interesting aspects of AVIM Therapy is the fact that we are -- we'll be forcing pacing in these patients who don't otherwise necessarily need patient because that's how you implement the therapy. And you probably heard pay attention to pacing that forcing ventricular pacing may not be a good thing.

Well, it turns out it's perfectly reasonable if you can do conduction system pacing. And as you'll see, this therapy, AIM is completely compatible with both regular ventricular pacing as well as conduction system pacing. So let's talk about the whole program.

So this started a little over a decade ago. There was the initial feasibility study for a preclinical study and in the first-in-human study, which is a single arm trial. And we're going to spend too much time on it. You can see that even in a non electrophysiology and interventional cardiology meeting, it won the best attack. That's pretty remarkable actually for a pacemaker to win the award their word there.

But then the [ MOTOR-T2 ] trial was conducted. This is a pilot trial as a randomized trial. It was sham-controlled, and it's -- and we have the data and we should look at that because I think that, that's going to likely inform what the pivotal trial is going to look like.

We have the initial data. We have the 2-year results. We have additional data beyond that. And then as you've already heard from David, there was a strategic collaboration with Medtronic and I don't know, maybe we'll be talking more about that discussion. And finally, the BAB pivotal trial.

So the trial is I'm sure you've already heard, it commenced a couple of years ago, 2 years ago, it just finished enrolling for the primary endpoint. We expect to early next year, and the data will be presented likely in the second quarter of next year.

So what is the therapy? It's basically pacing in an unusual way to drop the blood pressure. So instead of having the normal timing of the aim contractor, the ventricular and the veto contracting, it pays the ventricle early before you have complete filling of the heart. And what that does is drops the blood pressure.

Now in and of itself, that's not terribly interesting. Not is it necessarily desirable because normally what the body would do when it sees a drop in blood pressure like that, would be to constrict the vessels down, increase the resistance, and that's a bad thing. What's sort of remarkable about this therapy is you have some long delays or sort of normal delays between the atrium and the ventricle the interspace between these short delays. And that's what tricks the bare receptors, which are the receptors that would otherwise cause this peripheral vasoconstriction. You don't have that vasoconstriction.

So what you end up ultimately to a is a pacing therapy that drops the blood pressure without some of the adverse sort of consequences like increase in proper resistance. And that drops to blood pressure. It's an effect that's immediate. It happens right since you turn on the therapy, it's not something that will happen in some time in the future. So it's a very immediate effect, and it's a sustained effect. And so let's take a look at some of the data.

So this was the [ MODERATEOR-2 ] trial. So this is a pilot trial that's conducted almost a decade ago, a little less than a decade ago was a randomized sham controlled trial. So patients were blinded to their treatment assignment. So it took patients. The trial was conducted in 13 European sites. And patients basically were patients who had an indication for pacemaking therapy and who also had hypertension and had elevated blood pressure despite being at least on blood pressure medication, as you see up there. Do I have a No, I don't have that.

These patients were randomized 1:1 to either usual therapy, meaning they got the pacemaker and they're receiving their normal blood pressure medications or all of that, plus the pacing turned on. And again, patients are blinded to the arm that they're in. And there's an efficacy endpoint, which is, of course, a change in blood pressure. And the primary endpoint was at 6 months. The safety endpoint to assess for any safety events.

And in addition, at the 6-month time point, there was all the patients were crossed over to receive the therapy, and we have data out now actually past 2 years, almost 4 years, and I show you some of that data.

So here's what you see. On the far left, you see that a very important point, which is an immediate drop in blood pressure as you see a 13-point drop in better pressure. And probably one of the most interesting aspects is this, 97 respond. I mean basically, pretty much everyone has a response, a response defined by a immediate at least 5-millimeter drop in about pressure.

And then if you look at the ambulatory blood pressure over the first day, again, a 14-millimeter drop, which is pretty dramatic and compare that, by the way, to the control, sham control is basically no significant difference. And then the primary end point at 6 months, you see substantial differences in blood pressure, a drop of over 10 points, both with ambulatory blood pressure and office blood pressure with relatively minimal difference in the sham control group.

And this is pretty dramatic. I mean I don't know if you're used to looking at hypertension trials, when you look at, let's say, new hypertension drug trials, if you see a 4- or 5-point drop, that is a dramatic drop. Because remember, these are average numbers. in patients who are very well controlled typically. And so this is actually a very impressive drop.

And just to give you a perspective, 10 [indiscernible] drop in blood pressure decreases stroke by somewhere between 25% to 30%. That, by the way, is about the same decrease in stroke rate that we see with catheter ablation metro fibrillation. So these are not trivial differences.

The other interesting point, if you look at the 24 months, so these are all the patients crossed over who are in the control group. And so we follow these patients out for 24 months, and you see a sustained reduction in blood pressure something points. And then on the safety side, there were no important safety events, as you see go too far. No, this is good.

So this shows you the 24-hour blood pressure. So what you see here on the far left and the far right is doing sleep. You can see the times here. And that's the normal variation. So in the gray bar, that's a control group. You see the blood pressure rises a little bit as the patients wake up and then when you go to bed, the blood pressure drops, that's sort of normal.

Noticed that in the treatment group, there's a substantial decrease okay? And the decrease is both during the daytime and nighttime which is what you want to see.

Now the other interesting study that was done is this one. This was the reversible the -- what happens if you withdraw the therapy. There'll be times in the patient's lives when you don't necessarily want their blood pressure to be lower, right? Let's say the ongoing surgery or something else. And in those situations, the question is what happens if you stop the therapy. Is there going to be a rebound hypertension. And then if you turn it back on, what will happen.

And this is what happens. So you can see here on the far left, those are the orange bar, that's the blood pressure in those patients, and this is about 4 years out, practically. And you can see, again, the 122 is about what they had I read this wrong, sorry. The 122 blood pressure is in the group at 6 months. 4 years out, if you look at those patients, that's to day 0, again, it's basically the same thing, 122, okay? But then look what happens. If you turn off the therapy, the blood pressure goes back up to 133. So it goes back up. It doesn't go up higher. It goes back up to what it was before the patients receive the therapy, okay?

And then 7 days later, you turn the therapy back on the pressure drops back again to 124. I mean, in fact, this is actually even better than medications. Medications, you can stop them also and then start them up again. But the effect doesn't go away like this, right? It takes some time for the medication effect to go away. This happens immediately.

Okay. So that brings us to the current trial, the BACKBEAT global pivotal trial. So this is also a double-blind randomized trial or is a double-blind [ marinize ] trial. Conducted at 92 sites in 15 countries. About half the patients were enrolled in the United States. The total number of the patients, you see it's close to 350 patients were randomized.

The study is well powered, arguably 2 well powered, 95% of statistical power, both on safety and effectiveness. And this is based on 284 valuable randomized patients.

So this is a study where, again, looking at patients who had uncontrolled hypertension who are taking at least one and up to three anti hypertensive drugs. And there were patients again who had a bradycardia indication. So these are patients who either just received the pacemaker or about to receive the pacemaker. And they -- once they decided to participate in the trial, the software is downloaded onto the device, and then they were randomized one-to-one to either the treatment in orange or the sham control, which is the medical therapy.

The primary endpoint, which is going to, again, read out early next year, is the between group difference and change in ambulatory blood pressure at 3 months, so the 24-hour ambulatory blood pressure 3 months. And then there's also a safety endpoint. So the two important safety endpoints. There's the early one which again, looking at 3 months looking for unanticipated safety events. And then these patients are going to be followed out to 1 year. And that's going to be really important.

And the patients, by the way, are going to remain blinded out to 12 months. So they will be in their respective arms out to 12 months. And that's really important because we'll look for clinical events.

For example, we will be able to decrease the amount of atrial fibrillation, where we see changes in left ventricle remodeling where we see changes in atrial size, where we see even changes in clinical events like stroke, et cetera. And this is a reasonably sized study. So we may have hints of these phenomenon.

Okay. So the trial, again, very large trial. It's basically taking anyone who has a pacemaker indication, 6 sinus, AV block, all the expectations, expected patients. The patients are going to be older. That's what we expect. This is a pacemaker population. And they're going to have comorbidities. Again, they'll have diabetes, coronary disease, some of the patients will have previous stroke or enfarc.

We don't expect to have a large number of Afib patients. In fact, the trial excluded patients who have permanent or chronic aFibrillation. Think of paroxysmal Afib but not chronic Afib. And also important -- let me go back. Also important, as we said, the therapy, the AVIM Therapy can be activated soon after implant or could even be activated in patients who had a device implanted a couple of years ago.

So in terms of the yes, so in terms of the workflow, I mean one of the nice things about this is, as I said in the beginning, this is not a new device. There's no new widget. It's really just turning on the therapy on the pacemaker. And electrophysiologists are used to following these patients and cardiologists. They're used to following pacemaker patients. They come in every x number of months. we check out the device, we check out whatever other, let's say, other therapies may be on the device, heart failure therapies, et cetera. So I think in terms of workflow, I don't really see any particular problem.

Finally, I just want to end with this slide. So one is the point that David brought up in the end of his presentation, which is that while the trial is really directed at bradycardia indicated patients, so patients who need a pacemaker for bradycardia. The actual -- the FDA actually gave a label -- the label hasn't been given yet. But basically, we're expecting that the label will actually also include patients who don't necessarily have a bradycardia indication.

Now why would a patient necessarily receive a pacemaker just for hypertension. Well, I think we've already heard. I mean I think the market research that David talked about was very interesting. I think high-risk patients, it's very possible they'll what they'll be willing and interested in having a pacemaker even if they don't have a very [indiscernible] indication. And we're also going to hear from Marat, I think in just a few minutes, of some of the structural changes that we're seeing with AVIM Therapy.

And I think when you put that into the full context, I think it's very likely that this therapy is going to be used for not just the bradycardia patients. I think that's going to be particularly true with this. Let's see where is it, yes. With patients who -- in the future, hopefully, there's a leadless pacemaker therapy that's being developed by Medtronic, a single device that can pace and sense the top chamber and the bottom chamber. Again, this hasn't yet been used in patients. This is part of the development process. And hopefully, in the next year or so, we'll start hearing about first in human data.

But you can imagine a therapy like that, coupled with this AVIM therapy, suddenly, you have a very simple device that could potentially be used for hypertension treatment period, unrelated to [ Brady ] pacing. So with that, I think I'm going to go ahead and stop Yes, I'm going to go ahead and stop. Thank you. And I think we'll have time for questions later.

All right. Hello, everybody. My name is Murat Fudim. I'm a heart [indiscernible] cardiologist. My introduction was a lot shorter than that of [indiscernible], which I do not appreciate trail all the way from North Carolina.

All right. So what I will be talking about, though, is going to be an extension to what interpretive treatment really can achieve when you consider hypertension is the -- probably the biggest killer in the space of cardiovascular disease. It's a silent killer. It's how we often refer to hypertension. And perfectly seeing it.

So hypertension tends to be one of the key precursors to the development of conditions such as heart failure, which affects around 7 million people in the United States, the majority of heart failure in the United States is now driven by a condition we would call hot fill preserved ejection fraction.

And what happens is that if you -- as a heart, have to pound and pound and pound to generate a high pressure, 140, 150, 160 every day, all day, every day, the heart starts to become thickened, then it starts to dilate it in top chambers, and we refer to that as diastolic dysfunction. And it's really a surrogate of how pliable is the heart and its ability to move and relax the inflow of blood and inject the blood. Now why would you care about heart failure and hypertension being the main precursor to it?

Well, heart failure is sort of the bane of our existence million as indicated, this is the #1 cause of hospitalization in the United States. There's only one disease state that's more commonly coded in hospitals than heart failure in the United States today. any suggestions, what's quoted more commonly as an ICD-10 code. I see the tanks how we code things.

It's childbirth. Now I don't consider the childbirth to be a disease state. Having had to get my kids ready early this morning in North Carolina for breakfast. That it is a disease state. Some days, some days. And this is not recorded, right? My wife cannot see that material.

So the reality is that because hypotension is so proven and it's silent We, of course, have been treating it for years and years, but control of blood pressure is actually terrible. I don't know too much how much you know about it. But around 50% of all hypotension in the United States is actually not considered to be treated. And that it is treated.

And controlled is with the cost of many lose medications and people in this room probably to some degree, all those medications itself. And oldest 50%. And so if you do the math around 1.4 million patients that actually have heart failure have still underlying uncontrolled blood pressure and that being one of the key drivers of the disease.

Now there's a lot of microvascular changes that occur as well when you have high blood pressure for a while the heart becomes actually fibrotic. And that process takes a couple of years. Nobody says that uncontrolled blood pressure in 30s and 40s will lead to heart failure right away. It does probably take a decade or 2 for you to start developing structural changes. But the reverse tends to go a little faster because if you unload the heart and let it breathe easier. You'll start seeing change relative quickly. I'll show you some of that data here later.

Now I will not show you how great this device is in lowering blood pressure. That was the prior target. What I will tell you is where you should think beyond blood pressure once this is on the market. And that's actually all got involved in the company. I was not part of the hypertension program but realizing that there might have been some benefit to it. And actually, the company has thought about the benefits on the performance of the heart as it might relate to heart failure for a while.

And so this was a study of 16 patients where they took the standard uncontrolled haptens population given an implantable device. These patients obviously had some pacing indication. What they have done, they've done a PV Loop study.

And a PV Loop, just to give you an idea, it's a dedicated catheter you float either into the right ventricle or the left ventricle and it measures precious and volume at the same time. In the sphere of the coolest things you can do in the cardiovascular medicine, that is as detailed of a physiological assessments you can do, these catheters are also not cheap. But what it does, it measures volume on the X-axis and the pressure on the Y-axis. And you see multiple lines because what they do is they record multiple hard beats. You're not allowed to just record, so to say, on heartbeat. They're recording usually 10, 20 of the heart beat and then they average them out.

Okay. So what they did on it, they started pacing either in a typical RV approach on the physiological approach on the right side there. And what I found is that the orange is what happens when your pace and it moves to the left and down. Bring your PV Loops move to the left and down, it means the ventricle is becoming smaller and the pressures, systolic and diastolic are coming down, okay? So you have a drop in pressure that's what you have seen in prior talks, but it also brings down the volume. And it was equal, so if not more dramatic when they did the more physiological pacing think of his funnel pacing on those of a like.

So that was quite impressive. And so if you actually do the math, and I'll show you some of those details, not only decrease in daily systolic value, there was a decrease in systolic blood pressures diastolic blood pressure, which equals wedge pressure left and trickle and diastolic pressure, is that value came down.

Now it started in a normal zone because these patients did not have known heart failure. So it started in the teens and drop even further but it also reduced total peripheral resistance without significant change in stroke volume.

Having said that, stroke work came down. And it is actually the total area in the circles that came down. So the heart was able to perform at a lower pressure at a lower volume, and it's important for that because it does not like to generate too much work, so did all of that work at a lower work load, which we call stroke work.

Okay. So this is actually the summary of the individual observed changes. So now these are two different pacing modalities that were performed and it reduced the pressure similar to what you have seen, but this is now all acute right then down on the table, 17 to 19 millimeter. And if you now look at the volumes, the volumes dropped 12 to 18 milliliters on the diastolic volume.

On the systolic volume was 11 milliliters to 14 milliliters, those values are a little bit smaller because the hard actually squeezed in the meantime and just injected around 70cc, so you would expect those values to be lower. But most importantly, and actually also reduce the diastolic pressure. That's the bottom right corner. So there's a drop of 2-millimeter Hg. That doesn't sound like a lot, but it actually is because you started off around 10, 11, 12. That was the value when they started. So a drop of 2 points is actually quite significant. It's diastolic pressure.

Now that's a strong work I was referring to. The units are not quite -- are not as meaningful here because that is the area -- the total area within the PV Loop are there was less stroke work performed without significant change in stroke volume.

That's one question always comes up, what actually happens to the [indiscernible] stroke volume and it actually does not change significantly.

Now things that we perform on PV Loop, if I can go back, I hate to bombard you with this physiology. It might be boring or not. We actually plot curves based on the repeat performance of the curves. And we call them the elasticity. So we actually measure the elasticity of the heart by plotting curves this way and this way and repeat it over every heartbeat.

And then when we summarize them, we get these values that tell us what the contractility and the elastance of the vasculature is. And you see that the elastase of the heart and its interaction with the heart was to reduce so it was easier for the heart to inject blood into more elastic periphery and the contractility speaks directly to the controller to harden that actually did not change.

So we -- this therapy does not actually directly change the contractility performance of the heart. The muscle does not get stronger. It's really that we are playing with the loading conditions, so the preload than the afterload of the heart rather than change directly then in there, the eye neurotropy of the heart.

So that experiment has repeated now in a different patient population. That's a moderator two population that Doctored just talked about. But now no catheter was implanted. It was not a PV Loop catheter. Now they've done a single beat method where they looked actually just at the blood pressure together with the echo variables and it demonstrated very similar curves to patients that didn't have the therapy on for the first 6 months. And you see that the curve shifted. Not to the left and bottom it shifted to the right. So if you don't do anything in these patients of uncontrolled hypertension, they actually get worse. Eventual set of dilating and the pressure was rising. And you had actually a reverse of that therapy in the subsequent 6 months in those patients where it was turned back on, okay?

So again, repeatedly, this is a slightly different method, but the concept of the PV Loops was comparable and that has actually been repeated now a couple of other times and other data sets. What I'm going to show you now is we're actually started to get involved with the company. And that became quite interesting because when they started looking into their moderate data and showed all these beautiful data on blood pressure lowering. I approached the company and I said, "Well, this is kind of interesting because when I looked at the business characteristics, uncontrolled hypotensive patients in the 50s and 60s. They have a little bit Afib, they have pacemaker dependent. If I see those patients in my clinic, well, I call them heart failure patients."

Now the company told me well, that they were not allowed to have symptoms, and they were excluding patients with Frank heart failure. Well, the problem is if you ask a patient asymptomatic, think of your spouses or elderly parents, they will say everything is fine. The reality is that patients often with heart facts don't admit to the symptoms. So the reality is that many of them might have actually had latent or subtle signs of heart failure, which refers to diastolic dysfunction.

So what I asked the company is, why don't you disclose all the data to me, I'm blinded. I don't know who a therapy who doesn't and we're going to review all of these patients' charts that rereview the echoes to see how many of them have actually clear evidence of diastolic dysfunction. And what changes if we now pace these patients longitudinally, do we have an effect beyond [indiscernible].

First of all, some might have been surprised, I've been not a surprise, but 61% of patients that were getting this therapy at base that already had diastolic dysfunction. The clear evidence of destruction of the actual heart muscle whether it's a dilation of the atrium or being so stiff that they met criteria of poor relaxation.

Now in order to add into the trial that couldn't have told the doctor that they're symptomatic, I'm telling that some of them probably clearly, frankly, symptomatic, but that's how trials work you exclude as good as you can. And then what we do is we now assess these echos serially. Some of them got the therapy, some of them don't. And they had no insight into who got what. And so in a blinded fashion, this was not reviewed, like a core I would be doing this. And what we noted in one of the key metrics of [indiscernible] something called ePrime.Okay?

So I'm going to tell what ePrime. When the hardcore, it is actually to function. It squeezes like this to squeeze the blood out. But it also works like a pin function actually more important. That's a descend of the heart, like in the car engine, it descends and relaxes. And that relaxation is called ePrime. And it's very, very important. And the first thing you lose is the heart failure patients the ability to relax your harden like a spring to rebound, and that's measured by ePrime. So if you go up in a treatment arm, that is quite reassuring. And that actually increase is quite significant. And that was not seen in the control arm.

EUV prime, which didn't seem to change in the follow-up is another metric, but it's loading dependent. EUV prime is also piston function. That's the ePrime, that's the second point. But the e-component was that the sealing pressures had to be elevated for you to be able to detect the change. But these patients, remember, were not congested heart failure patients. That matter of fact heart failure, but it was sort of undisclosed and subtle. So we wouldn't have expected that the EoE Prime would be significantly different.

You're seeing that's perfect. Let me go back. I make sure this slide. Yes. Perfect. So what I hopefully demonstrated to you is that hypertension is a key contributor, silent killer. It's the most commonly prevalent cardiovascular disease in the United States spirit, also, of course, globally. And then only superseded about heart failure is the most deadly disease that will eventually lead to.

You have seen all the data around being a device-based therapy to treat hypertension, I will tell you, I'm involved in happening space. I help lead our hypertension clinic on top of our had filled preserved ejection fraction clinic. And I'll tell you that amongst the therapies that we have like real innovation, we actually tested things like expansion or innovation or clinic drugs that are coming to the market.

None of them has an immediate effect like this therapy. And that's one big benefit. The therapeutic of confirmation of technical success right in and there. So -- and again, we're just sitting in the office of reviewing some of the data -- that is one of the key advantages that you see the effect and the effect is in the magnitude much larger than any other therapies we typically see. And the key part is also is on 24/7.

Now if you actually go to patients and ask them how are you taking the medications of course. Yes, Doctor. I take my patient. That's also fast my teeth every time, too, by the way. And when you actually check the urine. In clinical trials, we check a patient here and we have trust issues that's in German me. We don't trust people. So we checkout clinical trials and what we find around 50% of patients don't have drug that's detectable or the drug that they promised us that would take, they would be not detectable in clinical trials. These are patients signing up for a clinical trial and the lying in all phases, okay? So the beauty of device-based therapy is that it's always on -- you do not have to rely on a patient's intake, which has for 100 reasons. There's, of course, issues with compliance.

So that's favorable hemodynamics, you can obviously hopefully follow my rationale. If you are always reducing the blood pressure by, let's say, 15 million to 20 million HD all day every day, that's going to accumulate over the months and hears this therapy is going to be in and I just showed you a 6-month data where there's already favorable changes in patients that were not symptomatic with clear evidence of diastolic function. You can imagine that it will accumulate in a properly powered clinical study. This will result in improvement in clinical outcomes, such as heart failure, hot failure-related hospitalization and really address what it was our biggest need.

And then to the fifth point that Vivek made earlier, of course, we have an infrastructure in place that actually does this. I mean, we refer to physiology all day every day. EP does not refer to very often back to heart failure. We have to talk about that. I think it was my last slide.

We're going to do a little discussion here. We're going to now get to some of our questions as well, and we're also maybe going to invite [ Allen ] and [ Duane ] up and I might have to be the standing the man without a chair, depending on how this goes, and I'm happy to do that. We've got good legs.

That's kind of weird.

Yes, I know. Darren, maybe kick us off, and I'll start going through some of our questions as well.

Right, I think a question that the audience and a lot of people generally want to know is what would be a good outcome of this trial? Like what would you consider meaningful, be excited about that what outcome come second quarter next year and we're standing on a stage excited? What are you going to be happy for? What can you kind of guide us to on what would be successful. This is AVIM question, just start with it.

I mean, I think that you can look at efficacy, safety and, let's say, applicability. On the effectiveness side, if we see the kind of drop that we saw in moderate to say a 10-point drop that was a mean. If we see a 10-point drop I think that would be astounding. So any double-digit drop, I'd be extremely happy with. So that, I would say, is a win.

On the safety side, we don't want to see any complications. And again, this is a large trial with 350 patients. So I think it's a well-powered trial to look for safety events. The fact anything in moderate to obviously makes me very optimistic.

But the third one, I think, which is also very important is the applicability. What percent of patients will show a response. And that's why I sort of highlighted that from the initial moderator trial. Where we saw what was a 97% responsiveness. So yes, I mean, I think those are the three aspects.

I'll add to that. You've got to put things into context. We were very excited and still are about things like real and innovation. But real innovation causes a 5 million to 6-millimeter Hg drop as compared to sham control. So I mean this is going to be a much larger change. And I'm just comparing those two because also two device-based therapies, so I think getting a double-digit drop in your systolic blood pressure is quite meaningful. And again, the idea that it's 24/7 all day every day.

Sorry, let me add one more thing because I forgot about this. Most of these patients are isolated systolic hypertension patients. And these are patients that are very difficult to treat typically in terms of blood pressure. So the fact that the majority of our patients are so systolic hypertension and the fact that we're able to treat them, I think, is really standing. I'm not sure how well, for example, not innovation or some other therapies would work in this specific population.

Yes. I mean I think those are the two things that stress me out about treating hypertension is I don't know whether it's going to work, the thing that I'm doing, giving them pills or renal denervation. And this, you can like see if it works. And it's not up to the patient as both of you made the comments, not up to the patient, whether it works. That's a dramatic benefit.

Allen can do the renal denervation. We don't even know when we're done with the procedure yet. And then we also don't know until later whether it really works or not for the three to five points of blood pressure. This is like amazing.

So I'm going to take a question from our app here because it's, I think, a good relevant to this discussion. So for clinicians, I'm jumping around a little bit, I'm trying to get them in the flow. For clinicians, based on what you guys are saying, assuming we see success in the trial from an efficacy standpoint, safety is a commercial therapy. Are there any reasons you wouldn't use AVIM Therapy on a pacemaker indicated patient who is already getting a Medtronic pacemaker. And if so, what would the patient criteria history be that would influence that choice?

Let's start with that also are hypertensive despite men.

Yes. No, I mean I don't see a good reason not to. So there were bad indication -- I'm sorry?

Well, we do not substitute meds. Let's say this is approved, right, and it works -- and there's 1 million side effects. Patients don't like to take their medications. Why not do the indications? So this was a study in patients who had not already achieved blood pressure control. But I think your point is well taken. I would not be surprised if some patients decide not to take some medications, and by 100% sure that once the therapy gets approved, people will be doing those kind of studies to actually use this as a substitute but that's just not how the initial. The study was designed. But your point is well taken.

So if we go back to the last couple of decades. Pacing is a bad thing. And here we are telling people to pace. And here you are getting up and telling people how excited you are about treating hypertension Dr. [ Pinto ] you are like you now looking at the actual outcome and the changes in the physiology in the cardiovascular that warranted concern? And how does that data that you're looking at, and if that data reads out positively, again, how does that change our whole perception of pacing?

Well, so I'll leave specific answer as to why this pace in safe pacing, but your company has actually done quite a bit of work of safety surveillance longitudinally. That's why [indiscernible]? Why would you do Eco [indiscernible] patients because there was a theoretical concern of you would actually pacing used heart failure. That's one of the concerns we have theoretically around pacing patients all day every day. but this pacing is slightly different. And that was just not seen in our studies to date that is closely surveil by the DSMB.

But what I demonstrated is actually the reverse is true because the patient has chosen to have so much dial dysfunction and stiffness in first place that is really the hypotension by treating it outweighs any potential harms they've seen so far and you can extrapolate this at some point in the near future, could become actually a dedicated heart failure therapy, where we, by the way, test and in EP Rob sits in first role, you did do a lot of pacing dedicated heart failure therapies in the space of [indiscernible].

I saw an anaphylactic reaction from the Medtronic people about pacing as bad. But what I will say is, as a [ TAVR ] person also, we have to be a little more circumspect about labeling pacing is bad. There are a couple of Class I indications that save people's lives with pacing. And if you have an ancillary benefit, for example, with CRT after a [ TAVR ]. That's in aortic regurgitation, that's a big deal.

Or if you have -- you can get a pacing ICD that shocks you out of death or if your hypertension is treated better, those are life-saving devices.

I'm going to jump back to some more -- some more questions we've got from the app here because we're -- we've got some time for that, and we also have some more discussion. We'll work our way back to Virtue as well. So one question here related to data as well. Sometimes we see control arms in rigorous well-run trials for hypertension, have better clinical results than expected.

What do we expect here? Do we expect also that the AVIM Therapy patients in the BACKBEAT Trial could do better than the [ MODORATO-2 ] trial. So two questions there that we.

Yes. So when you think about hypertension trials, when they're well done trials, you don't see that kind of fluctuation. See, hypertension does this. we just follow people over time. This is what hypertension is doing.

If you do a trial where you're not carefully assessing pressure where you don't have a study where, for example, you don't take patients just when they happen to have their blood pressure high, but rather and to the patients and follow them for a month or so as we did in this trial to make sure that their blood pressure is really high. When you do the trial carefully, then actually, the control patients tend to behave as you'd expect.

So that's the reality. So I think that some of the I guess the sort of knee-jerk sort of concern from the simplicity experience, which is where I think this question came from is really not warranted. In this particular -- for this particular.

I would highlight we have a running period, which we and the do fully expect to see from initial consent through the running period, which may be it's going to be a minimum of 30 days. There will be blood pressure reductions from when we meet the patient who may not be compliant at the time of consent to when we bring them in, we also do. We saw it in [ MODORATO ]. We did see reductions. So we expect that. But I think the other question, is there a chance that we can see better results is something that was also asked.

I'd like to jump in on here because one of the in the room here is 1 of the con vendors and founders with us, you all [indiscernible] this therapy. He always says this question is for a therapy that doesn't have tremendous benefit. And what he's saying is when you make a big change in blood pressure, you're less worried about the small numbers about what the control group does. And we're seeing very large changes in blood pressure.

And so I wouldn't be surprised, and I wouldn't care if there are small changes in the control group because the therapy itself overwhelmingly provides benefit.

David, second question was could see numbers better than [ MODORATO ]? We think so. We worked for 10 years to further development and work with algorithms and work with our partners to learn from what we did in the past to make it better. There's absolutely a potential for us to do better.

But the first question was an important question, which is if we just repeated what we did, would we be happy? Is that a good thing? And I think everyone agrees that's a good thing. Anything more than that it's going to be a party.

But the second question, I just really want to address that. It's interesting in the data that [indiscernible]. When you looked at the changes with conduction system pacing versus regular right ventricular pacing, the changes were actually -- they seemed more striking with connection system pacing. So there is a small reason to think that in this trial where half the patients served so will probably have conduction system pacing.

We may actually see a more significant benefit. Again, this is just the hands of the app. I'm looking -- I'm really looking forward to seeing whether or not we see a greater benefit in that population.

There was one more question app, but I want to just address before you go to the next one, David. And the question was, will so could any pacemaker go do this? And the answer is it really isn't. Like we had to go rerun the software and rebuild it and revalidate in order to program it to do these interchanges on how to go do this.

This will launch on a Medtronic platform, which they're going to apply for approval, get an indication, get an approval. And the therapy is only going to be available on the devices that they sell. So this is not something that somebody can do with an existing program or existing pacemaker. So while we're leveraging the history of pacemakers, this is particular to the devices that and Medtronic are going to launch. And I just wanted to make sure that question [indiscernible].

Sure. A bunch of questions. I'm going to answer a few just because they're quick. We had a question about the 3.7 million patient number for the expansion market. That's a global number. We believe the annual addressable it's around 1 million patients in the U.S. And we've looked at that rigorously.

Let me just make clear, there's 120 million patients in the United States diagnosed with hypertension. So 1 million patients annually is a fraction of a fraction. There was a question about how many patients have hypertension to get dual-chamber pacemakers. I will -- it was lower than our number. I'll get you the paper. The most recent paper came out about 1.5 years ago. The reference is 85%. I'll pitch you that one.

Question for you guys, 3-month primary endpoint results. Is that enough to move physicians? And if not, what are you looking for?

Yes. I mean I think so. In 3 months, you're going to have -- and if you see a significant difference as we saw moderate to absolutely. And just remember, we will still also have to data -- the patients are going to remain blinded to their treatment out to 1 year. So we'll also have that data.

The other question is statistics are powered for finding a difference between groups and ambulatory systolic blood pressure of 5 millimeters or greater. The question we had is, is that going to be viewed as clinically meaningful?

And there was a follow-up, and I might indulge if you're willing, Rob. The follow-up question was is -- let me just make sure I have it here. It was -- is that enough for Medtronic? I think was a question. So I think -- so is it enough for the clinicians, but will that type of difference if you want to jump in, be meaningful to you guys commercializing the therapy. I'll give you that. He's the only one who gets a mic by the way.

Look, as I said before, even a 5-millimeter difference, if it's a statistically significant difference, that's what you see with most new anti hypertensive drugs. So I think the answer is yes. Particularly when...

By the way, not ambulatory. You tend to only see that in [indiscernible].

Yes, that's true. And particularly when you're talking about basically turning on a therapy, I mean, this is not -- we're not talking about a new procedure in this patient. I literally just flipping a switch.

I'll stand for a second. For those who don't know me, Rob Kelly, I run the pacing business at Medtronic. And I was a clinician years ago. I've recovered from that already. But no, I would say the really -- I'm fully aligned what Vivek says, not to extend the repetition too much, this way. Okay. Sorry. I don't want to block them.

5 millimeters is clinically significant. What we care about is what's clinically significant for a patient that's going to lead to a better outcome. There's a wealth of data about how you can kind of look at the benefits from a cardiovascular and stroke standpoint, by how much you lower and 5 is meaningful.

I think the secondary point, which is actually critically important. These patients are already getting the pacemaker for another reason. You're not putting them at any incremental risk unless we find something in the trial that this therapy on top of the pacing creates risk. I think we're very well be examining that, but we're very confident that that's not going to be the case.

But again, you're not asking someone to undergo a new procedure, a new expense related to getting the additional therapy, and that's what's a critical component of this for us.

Thank you, Rob. And do you want to change gears a little bit?

There's a couple of virtue like questions that came in. One of them was like -- can you tell us about how this product is made in manufacturing and stability and nice commercial kind of questions. The beautiful part about virtue is you make a pharmaceutical agent with a lipolyses product in a vial and a drug and you use standard techniques to go do that drug and you make a device. And the device is going to have 2- to 3-year shelf life and be stable. And the same vial drug can be used across all the different codes and sizes, and it creates a lot of flexibility for a hospital where you don't have to have drugs sitting on the shelf with shelf life.

We continue to produce this and learn and grow and make our manufacturing at scale much better. and our stability is growing every day, and we continue to provide the agency updates on a routine basis as we get more stability data is growing. It is a very unique product sense of you make a drug on one hand and you make a device on the other, both well known, both completely different. And you don't have to live in a world where you have to get the drug to interact with the device and make a shelf life together. We can keep them separate. So a unique program for that perspective.

Another question came in and I'll address it to you guys. Hey, you're running a non-inferiority trial, and you feel confident there's going to be superior or you hope there's going to be superiority. What does what would be a meaningful difference in the separation of these lines that you could drive your decision-making beyond [indiscernible] powering?

That's a great question actually. It's always the question you can make the sample side industry large have a statistically significant difference between two therapies, but it's not clinically meaningful. And I think this is what this question is.

And I would say this, right now, based on the current therapies we have and the data we have, the 1-year event rate of target vessel failure is about 16% or so. But you saw the 3-year data is like 35%. So if you get the 3-year data to be around 15% or 20%, I think that would be a pretty dramatic difference.

It's difficult for me to answer that because it's not a numbers answer. It's a qualitative answer. I could give you a stats answer of what in a non-inferiority trial, subsequent superiority testing and stuff like that of whether it would be compelling to me as a clinician. But to me, numerically better in something that where the curves start to diverge, I would assume they would continue to that version want to see the data.

But early, if there is a superiority signal, whether it's p-value or not, and it's numerically in the favor all the science lines up that this should be -- like it's built on a foundation, not a statistical modeling foundation.

So the science lines up, the first primary outcomes, that is enough for me to switch because there's not going to be a safety issue. So I think everybody in the audience would say, "Well, wouldn't that want to think that better and then let the stats play out to 3 years", as Allen said.

So just to reiterate, because so a numerical difference at 12 months is part of what you're talking about doing, which will get your attention. And I guess what you're saying, Allen, I just want to make sure I understand, is a numerical difference in 12 months could translate into a widening difference over longer time frames, particularly given the long-term data we're seeing from drug-coated balloons.

I think that the 1-year data is not so bad, so of spring more than 80% of patients at 1 year are fine. But then when you start following them out, I think the data is somewhat disappointing with the current technology. And you say more than 1/3 of patients coming back, right?

So I would say if you can meaningfully reduce that number, I think it would be a win. You also have to kind of think about -- and I don't want to go into all of these details, but it's not so simple, depending on what size tend is it how long of a stented is a side branch or a main branch? Are we talking de novo disease or stent failures. So all these numbers are different, right? And so the expectation in terms of long-term outcome is different for this subpopulation well.

I had this answer for the company for a minute, which is was a question about why do a non-inferiority trial rather than a superiority. Some of that comes down to resources and time, optimizing for statistical superior it requires you to go larger. That said, the signal that I think that we see, we think, gives us a shot. This point is really important, which is you have three different atoms. You have noninferiority. You have noninferiority with numerical separation with directionality that could be significant and then you have superiority. So obviously, we prefer the latter to but we think we're well set up. I think there was a question that maybe -- go ahead.

The sample size and trial design was really based on agent and agents performance as well as our prior performance. If we meet our intent to treat and they meet their past performance, you're very close to being statistically. If we get any closer to our poor protocol compared to what we before, we will.

So this is a trial that's designed for noninferiority. But if we can perform like we expect in the prior trial looks like, there's a real potential that you have a separation and there's a real chance that you can get statistical.

And again, it's -- you're comparing paclitaxel sirolimus. We know sirolimus is one, and you're dosing at higher levels for longer. And there's reason to believe that this could be significant.

A question on the pivotal analysis designed to assess virtual results versus -- in 1 or 2 layer stents. And maybe we could just comment on how we design the trial. And maybe ask a question if there's any expectation that there be a difference of effect for Virtue versus drug-coated balloons in 2 layers of stents?

I think 2 layers of stand post another level of problem, which is the mechanical issue of having 2 layers of stent with recurrent instant restenosis. And so obviously, one hopes that having more potent and higher concentration of sirens will help I think a lot of it is about the prep. And so in this trial, it's limited to 30%, so we cannot go over 30% of AA or multilayer stents will be in single layers. It's really difficult to predict, honestly, how it's going to shake out. We know that those patients do very, very poorly. So to be honest with you, the bar is not very high.

I mean the reason is stratifies because there are different patients or different populations. And you want to see if the treatment effect is different in those populations. There's a little bit of a trite saying that if you have a therapy that works, the higher the risk the individuals the more you have to shine. That may not apply to double layer stent because in those cases, you may be destined to fail.

So -- what you want to know from a scientific standpoint is the two different populations, how is Virtue performing? And if there's any shot on goal that's going to work, it's going to be a merchant.

A couple of questions on just follow-up on mechanism. I think we talked a lot about mechanism of action for Virtue in terms of delivery. Maybe I ask you, Darren, the question here has to do with the IP associated with Virtue. And maybe the bad as it relates to the mechanism. I am paraphrasing the question, I apologize, but the thing I got to the gist of it.

Yes. So this is an interesting question. We spend as developers and engineers, as company created, so focused on IP across our company. We have, I think, 4 or 5 people that have 100 or more patents in their own fields. So we have a lot of innovation in this company.

There was a conscious decision when we started working on this pharmaceutical agent not to file IP and keep a trade secret. The time line that goes for the development of a drug is hard what we've created a new particle system and how it's manufactured and how it's tested and how it's evaluated. We have not disclosed in this trade secret. That being said, the interface and the interaction with [indiscernible] fusion boon is patented. And it's the interface of how these work together is patented and those patents continue to be forthcoming.

We're actively working on the next generations of these infusion type devices for different applications and other enhancements in our current, that continues to be follows patents. So I think as hindsight is beautiful. I think the choice not to file patents was a really good one. We're now on our 16th or 17th year working on this. As those of you who know patents, that's a long time and that becomes priority and that becomes something that other people can take off from. Nobody knows really how we have developed this and built this.

And it's a significant thing to say because big pharma hasn't developed a long-acting sirolimus. This was a very wise choice of ours to not disclose.

The shift back. Vivek, would you expect you or the Mount Sinai practice or other practices to move your implant volume from one vendor to another vendor based on the availability of AVIM.

I mean I think we're going to have to because -- once the cardiologists know about this, we're still well pretty quickly. I mean, assuming a positive trial, et cetera. They're going to want the device. The patients will want it too.

So there are very few things in pacemakers or devices that actually capture people's imaginations. For example, when pacemakers became MRI compatible, that was a big deal. If you weren't MI compatible, you could not implant the pacemaker, that happened very quickly. I think this is going to be another one like that.

So I [indiscernible] other compelling reason, I can't think of one right now. I think we're going to be sort of forced to implant.

Yes, it's a quite competitive market. It's not competitor market to go beyond the pacing, which is standard across all pacemaker that's what they do. They've been developing for years and decades. So that feature is actually something very important also to referring providers. We do that for the high-voltage devices where features of the high-voltage devices such as having good remote monitoring, have not good remote motoring is as little as that already tells us to wanting one device over the other.

And I think this will be a far greater incremental factor to consider when referring for pacemaker then battery longevity, 8 years. These are minor details as compared to -- oh, this is also treated or pressure by 15 points. That is big, big, big deal.

There was a question about that, and that half year is about this exactly roughly the worst-case scenario on battery. Did you want to say something?

I just -- I want to make a nonproprietary comment. Why use a pacemaker, right? It's like it's a boring product. So I've been told. I don't find them quite as boring as everyone on the stage. But -- it's a sailing factor, right? It's been around for years. It's a different device, but it's the exact same procedure. It's the same box. We know how to manufacture them. We know how to do it with a quality level that is understood and accepted. And there's numerous people who know how to implant. So if you want to take a therapy and scale it quickly, use a pacemaker. If you want to do it slowly, pick a procedure with a new product that has to train and then there's an unknown safety profile and all these other things.

I think the beauty of using a pacemaker and the reason why we engaged in this is that all the -- not the unknowns, but all the knowns. And when you look at all the knowns, and the ability to scale quickly, that's what health care systems want to see. The ability to take a new advance and scale it. And that's how we think about things as well. So I just wanted to...

So I think leave the stage Well, I think we're almost done. I might -- who wants a little more because no 1 seems to answer. But we have -- we do have cocktails, but I think we maybe could just get one or two more questions in -- this one was interesting, and we're not going to get to all of them. I really appreciate the questions. But just focusing just back on Marat's presentation, we got a question, will we get any data on the possible improvement in heart failure in patients included in the BACKBEAT Trial. And it be interesting to talk about the Echos data in context, we have Echos. But maybe we just talk about what's in the trial and what might...

What would b.

E probably better see. But actually, that was an active issue to be considered when the travel designs to capture the echos when they're done to look at -- by the way, every time you do an echo, you don't only look for safety purposes, but you actually capture the distal components and then, of course, capturing events. I mean, in the perfect world, and I think that is -- there's a good chance it will occur in one follow-up, you might have actually a few events.

These are high-risk patients. But I just told you have 60, maybe less, maybe more prevalence of decimal function. Some of them will have actually Frank heart failure that is just not known to us. There is a chance you actually have few also events that are heart failure related, whether it's an ER visit, hospitalization, stroke.

Quick question because I saw the same reaction when you showed pressure volume loops of every medical student about to like pass out from boredom. But I actually thought they were pretty good. those pressure volume loops were very compelling that there is a significant improvement in the physiology.

And if that's the underlying physiology that's got to translate into lower event rates at least rehospitalization and easier management. But I mean the afterload that you showed the Alaskan change is in and of itself.

I mean beyond -- so it would be one thing if the black brusher changes, but here the pressures and the volume change in a favorable direction, meaningful, not just a little bit. I mean, a couple of points on a wet pressure reduction is a big deal in a healthy individual will be even larger and heart-failure patients. So I think if everything moves the right way, was a magnificent change, but the key part is acute. And then I'll show you also 6-month data.

So if those things continue to be consistent, we know that lowering blood pressure in this population like will not result in harm, but actually, we've seen the opposite that it sort of steps. It's all the benefits not stacking. And then the right patient population will result in better all of those.

So in the middle of the trial -- in the early part of the trial did accept [ NYHA ] Class II patients, so getting some a little more symptomatic. And we've concluded [ KCCQ ], which is a heart failure question here and quality of life questionnaires. The study is not going to be a 1-year study. The study is going out to 3 and likely 4 or 5 years. We'll be following these patients for a long time.

I think the data that comes out the top level data that will come out in May of next year is going to be exciting. But the gift that's giving is this is a trial that wasn't designed for regulatory approval. This is a trial that was designed to be standard of care and change medicine. So there's a lot that's going to come over time.

So one other thing I'll add is that I'm going to be looking for -- and certainly the changes in chamber dimensions, LV volumes and even LA. volumes. But one of the other aspects is electrophysiologists, potentially see less atrial fibrillation, less burden of atrial fibrillation because there's nothing that's more anagenetic than atrial stretch. So it actually is decreasing. So that's another area that I think we'll be sort of focused on.

We have one more question to Allen, and I'll wrap up. We're going to have this group for -- in our cocktails. So hopefully, you won't get to every question, but if you can get to one of the doctors corner them and get your questions in. But Allen, we show data with PK 13 nanograms per milligram in terms of our animal data versus one for a stent. Is anything about that concern you? And I'll ask the other part of it, does anything about that excite you. And [ Duane ] too, in terms of that question.

I'll take an exciting part, if you want to take the concern part.

I'll take the concern by first. Okay. My understanding is that the only way to [indiscernible] is if somebody drops a big bag on your head. Basic which hopefully won't happen in the cath lab, right, because -- you have one accident today but we don't have a bag of this I think we're going to be okay. So the therapeutic window is enormous, right? It's a very, very safe drug. It has been around forever, like you say. And there is basically no downside.

It sounds like the excitement part to me. No, that was a negative part. No, I don't have anything to add that. I mean, that was a good part. I mean there really is a very wide therapeutic range for sirolimus. The downside is when you fall below the therapeutic level as Allen showed nicely in his slides, which were great, by the way.

So what -- I think that we both are answering the same way because I'm unconcerned. And I just don't want it to fall below so that we have the same problems that we had. For example, when we're used therapies that were not therapeutic.

So I think we go make a few comments, but we had questions about reimbursement. I think the -- on both programs. One of the things that we've talked about to investors is the reimbursement set up is, we think, one of the most exciting things for both of these therapies. Pacemakers are reimbursed. We do have breakthrough. We see upside on that. That's something that we're going to -- we're working through in terms of how we're going to pursue it.

The same thing that was true for drug-coated balloons. And one of the things we're seeing as new devices are coming to the market is the NTAP TPT, we'll see those codes become permanent. And ultimately, that's actually affecting how some of our competitors are timing their commercialization to make sure the permanent reimbursement applies. So that's nothing -- the question we had a couple of times was are we going to find a partner for Virtue?

We are committed to our partnership business model. The strength of our balance sheet, though, gives us flexibility to think about when we do that, how we do that. We think there's a rich landscape and we think there are people here that don't work in that side of Medtronic, it includes Medtronic. But at the end of the day, we'll do that at the right time in the right way. We're thrilled about the partnership we have with Medtronic, and please find Rob or Chris or Matt, you can talk to them directly. Hopefully, we'll hear -- we expect to hear more from Medtronic directly as we move to the data, and we expect to be talking about that data together.

There's a lot more questions here that we're not going to get to. I'm going to just say thank you all for being here. Thank you for being online. Most point thank you guys for the work you're doing with us and for taking the time to share your thoughts, share the presentations and have this discussion. I wish we could go on for another hour. But we've got people to feed and drinks to have.

So enjoy if you're not here, but thank you guys so much.

The clock started ticking down. So I think that means it's time to get started. Thank you very much for joining us with Medtronic today, the CFO, Thierry Pieton, I appreciate the time. This is Peter Harrison from Morgan Stanley's Investment Banking Group. Maybe real quickly, why don't you -- you've been with the firm a little over a year, I guess, now maybe real quickly a little bit of your background and what attracted you to Medtronic and let's jump straight in.

Sure. First, thanks for having me, and thanks, everyone, for being there. Yes, so I've been with Medtronic for 1.5 years, attracted by many things. First of all, the sector. So I had begun my career with GE Healthcare. So I've always kind of wanted to come back to MedTech at one point, I love the mission that Medtronic drives. I thought I could bring something from my automotive background as well to help improve the business. And as usual, when you're picking a new company to work for, a lot of it was just the interactions with the people with the CEO, Jeff, with some of the presidents of our other portfolios, et cetera. So felt like a great fit. And it's been 1.5 years, and it's been an absolute honor and privilege.

Great. And it's been a bit of a volatile year for med tech. And so one thing that came across in the second quarter earnings were ACA subsidies, impact of procedures, capital equipment, cuts and spending. How are you thinking about that impact? And what are you seeing at Medtronic.

Yes, we get that question a lot. I think our portfolio is maybe a little different from some other MedTech companies in the sense that we tend to focus on acute procedures. So typically, if you have a stroke or if you have arrhythmia with your heart or you need a valve replacement, you have to get it done, right? It's not an elective procedure. So what we're seeing is the strength of the procedure volume has actually been really good. And you could see it in the numbers in the first quarter. Our biggest franchises, cardiac rhythm management, surgical, spine, they've all been performing very well. If you look at our sort of revenue mix, about 2/3 of it is Medicare. Another 1/4 is sort of private payers and Medicaid is -- Medicaid is about 10%. And ACA for us is less than 1% of our global revenue. So it kind of shows you the mix that we've got.

Look, overall procedure strength has been good. And I would say one thing that is interesting, our free cash flow performance was really good in Q1. And part of it was accounts receivable. So we're actually going to -- we're getting paid well, both in the U.S., even in some typically challenging geographies in Southern Europe, et cetera, where it's always hard to collect the cash. Q1 was very strong. So I think we see a lot of underlying strength generally speaking.

Great. That's good to hear. And the other macro trend, obviously, a word we're hearing a lot of AI. How -- that's on everyone's mind right now, and it's transforming many industries. How is it impacting Medtronic and med tech or hospital spending or whatever it might be in your view?

Yes. So for us, there's really 2 big things. One is in the product part of our business and one is sort of efficiency early. If you take the product part, AI just gives us an opportunity to improve the procedure workflow, make the results better for the physicians, provide a better service for the hospital, improve the outcomes. I'll give you an example, right? We've got AI attached to one of our endoscopes GI Genius. And the result is that through a typical endoscopy procedure, the AI detects 50% more polyps than a trained physician would with a naked eye. So it's great for the patient because you get a better outcome.

It's also great for the hospital because maybe you can have a slightly less skilled physician doing that operation, right, because the system is going to help. Another example would be, in some of our spine procedures, the AI can help you do pre-op planning. So map how you're going to do the procedure, help you through the navigation during the procedure. And at the end of the procedure, give you feedback on what you did differently, better, what took more time and so keep improving the way you actually do it.

So if you think from the patient, from the physicians, from the hospital, there's a lot of benefit. So for us, we're in a great position to kind of integrate the new capabilities into the products. And then there's obviously the internal efficiency part of AI. The obvious stuff is for back office, like I run finance, and we have more and more operations that are being digitized such as accounts receivable collections, et cetera.

In R&D, we're increasing the amount of software development that's done through AI directly. So it just speeds up the way the company works and we get efficiency out of it.

On the product side of the ledger for AI, are you able to get -- to monetize that? Or is it just kind of bells and whistle to sell the product?

Yes. So if you take the spine example that I was giving you, right? So the basic product used to be implant, right? So you'd have a problem, you'd go in, you'd have an operation, you get an implant. So a very competitive I don't want to say low tech, but almost low tech type of product. Now with the fact that we've got the full stealth access solution, preop, intraop, post-op with the navigation, the imaging, the robotics during the procedure, et cetera. It's made the implants a lot more sticky with the customers, right? They want to get stuff access because they know they're going to get a better outcome. The physician knows his mental load is going to be reduced by the AI. He knows he's going to get the assistance from a robotics perspective.

So that can be monetized, right? It's made the implant stickier, and it's enabled us to protect the pricing.

Great. And look, we've seen -- in my mind, you've seen Medtronic really pivot its growth right and that was just demonstrated pretty robustly in the strong fiscal year Q1 results. What do you think has driven this strength? And do you think the new kind of growth rate you guys are at is sustainable into the near medium term?

Yes. So look, I mean, I think it's always a combination of things, and it's not overnight. So you've seen our growth rate sort of steadily increase from 4.5% to sort of 7%, excluding the impact of the extra week that we had in Q1, and it's a combination of things. A lot of them is around obviously innovation, right? And so we've got these 4 big generational growth areas that are driving a significant portion of the top line, cardiac ablation with Affera, Symplicity, our renal renovation hypertension procedure, Hugo in robotics and Altaviva in Pelvic Health. These are all at different stages of development that I'm sure we'll talk about them. So they're driving a portion of the growth.

But the teams have been driven driving innovation in sort of the more, I would call, traditional or historical parts of our portfolio. So if you look at cardiac rhythm management, which is basically what was at the start of Medtronic, right, with a pacemaker, that business had 15% growth in the first quarter. And it's really through innovation. It's CSP with high power and low power with products like OmniaSecure and our 3830 lead. It's been EV-ICDs. It's been leadless pacemakers like micro. Micro is almost a decade old now, but it's still growing high double digits. And so it's really continuing to transform a franchise that has been around for a long time, but through innovation.

A lot of our competitors have seen cardiac rhythm management as sort of a low single-digit growth type of franchise. And we don't see it that way. We've continued to innovate there, and it's driving the penetration. In the neuroscience portfolio, I talked about spine and the impact of Stealth Access. In the other franchise, we've got meaningful innovation in every single one of the subdivisions like in Neurovascular, we've got RTs, we've got Onyx, which is an MMAe product. We've got Scientia that is a recent acquisition, in our ENT business, we've got Stealth Access, so the full solution applied to the ENT business. In Pelvic Health, we've got Altaviva. So every single key operations that we've got has meaningful sort of innovation going on for it.

We measure what we call the vitality index, which is the proportion of our revenue that's generated by products that were launched in the last 3 years, and we used to be in the teens. And now we're kind of in the low to mid-20s, right? And that's going to continue to go up, and that's really key because that's where the growth comes from. And it's also obviously good news from a pricing perspective because innovation commands pricing.

And how do you get conviction this innovation cycle that you're taking advantage of now continues into the future? Because you do have generational products right now. How do you ensure you have a generational product in 3, 4 years?

Yes. So the first thing is the base franchise is right, our bread and butter business, so CRM, Cardiac Rhythm Management, Cranial & Spinal Technologies and surgical are humming along well. So those are stable. They're continuing to grow with innovation. On top of that, we've got these 4 big drivers, and they're all at different stages. So cardiac ablation is the most advanced one. It just lapped $2 billion trailing 12 months revenue in the first quarter, ahead of our expectations. And we know that's going to continue to grow in the coming years for several reasons.

Behind that, we've got the hypertension procedure, which is really still at its infancy, right? But it's a 15 million patient pool with a $16,000 procedure. So sort of 1% of that pool is north of $1 billion. And it's really in its infancy, it lapped $100 million of of turnover in Q4 of last year. Altaviva is probably just behind it. So Altaviva is the urinary incontinence procedure. It's a small implant in the ankle, and it -- it treats people who have overactive bladder. And so they can do that instead of getting BOTOX injections and more heavy procedures. And it's, again, the 15 million potential patients, 5 million of which are actively seeking treatment. At another sort of $15,000 to $16,000 procedure. So you can see how much that represents.

And then we've got Hugo in robotic surgery, which is a massively growing franchise for us. And so the good news is the base is strong and accelerating. And these 4 generational growth drivers are kind of in rapid succession. And each one, very material.

Okay. Great. And look, you talked a little bit about it, but CAS continues to be a bright spot in the portfolio. Is this level of growth you're seeing sustainable? I mean we talked about the technology innovation, but other factors that will continue to drive this growth?

Yes. So look, first of all, it's a growing market, right? So it's a market that grew 14%, 15% in the first quarter. It's an under penetrated therapy. So the good news is the pie is expanding. But we're taking leadership there. So we grew 88% in the first quarter and that franchise. Obviously, the comps are going to get more and more difficult, but we see the growth continuing for many reasons. One, commercially, we're still only targeting the large accounts in the U.S., so they're kind of 30% that account for 70% of the revenue. We're only at about half of them. And even in that half, they want more mapping systems. So we're really at the beginning. We're expanding geographically. So we launched our key products Sphere-9 in Japan at the end of last year.

So it's starting to grow there. We're expanding in new indications. So we expanded ventricular tachycardia in Q4, that's another $1 billion opportunity for us, and it's growing quickly. We've invested in ICE catheters for imaging. That's another $1 billion opportunity. And we've got a new catheter called Sphere-360, very efficient catheter for simple procedures coming in the U.S. that's going through the approval process.

So commercial products, ecosystem and sort of our indications, we still have a lot of runway ahead of us. So look, it's -- we feel like it's got opportunity for growth. Our ambition there is take leadership. And to give you maybe one stat, the installed base of mapping systems grew 40% in Q4 and 35% in Q1 sequentially and that's future pull-through of catheters, right? So it's a great indication of of where the business is going in the midterm.

Great. Obviously, you just announced a major investment in a soft tissue robot in China. You talked to Hugo as one of those 4 growth drivers. How do you think about the tie-in with Hugo, how Cornerstone Robotics ties into Hugo and why this company?

So look, first, if you take a step back from a macro perspective, the surgical business is our biggest business in the portfolio. And we're one of the leaders of open surgery and laparoscopic surgery. Typically, if you're a hospital today, you really have 1 or 2 partners. It's either J&J or Medtronic, right? So we have a big surgical portfolio. Within surgery, the part that's growing the most is robotically-assisted surgery. So it's vastly underpenetrated, 5% globally today. It's growing very, very quickly. So for us, we want to take leadership in that area, too, right? And so for us, it's -- we have a successful robot now with Hugo. It's been successful outside of the U.S., got approval from the FDA end of last year in the U.S. and it's ramping up.

But what we've discovered is customers in this vastly growing field, they want choices. Some of them want modular form factor. Some of them want a boom design. Some of them want an open visualization, some others want immersive. So it's become clear to us that you need to offer choice and access to customers. So the investment in Cornerstone is about finding a partner who can accelerate being able to provide that choice to our customers, right?

And so we went out and we considered doing it organically, and we looked at potential partners out there. And with Cornerstone, we found someone who has great tech, so great visualization, great instruments. So they have and 8- and 5-millimeter rifted instruments on the arms of the robot, which is quite rare actually in the sector today. They have a very vertically integrated offering. They have approval in China, CE Mark and in Singapore, so they can commercialize in 50 countries. They have a great leadership team. All people trained in the U.S., Hopkins and MIT doctors and et cetera. And so a great fit with Medtronic.

We have the capability to help them with the distribution. They have the capability to offer this choice to our customers. So we're super excited. This is about us going on offense in this high-growth sector and just being on top of it. So we made a large investment. It gives us optionality for the future, right? We like making investment first and then learning how the company works and seeing if we can do more. So potentially, we'll do more in the future. But yes, it's a great development and we're exciting to see how that moves forward.

Great. That's very exciting. If I think back the last couple of years sitting here with you or Jeff or whomever, Structural Heart was always one of the products featured in this innovation cycle of Medtronic, and that's kind of stepped away a bit. What is the plan for this business? And what does the path forward look like for Structural Heart now?

Okay. I mean it's -- first of all, it's a segment that's growing, right, as a market, and it's a highly profitable one. And it's one where Medtronic has a strong sort of second position. And so it's an important franchise for us, and we want to invest in it. And so -- you saw us invest in Anteris, which is our balloon expandable valve, a few months ago. We just announced an investment in a company called Pi-Cardia that does leaflet modification that can be very useful in kind of TAVR and TAVI type of procedures. So we're going in offense on the inorganic side. We're also investing in mitral and tricuspid programs organically. So we're in offense. So it's probably going to take a couple of years before we get back to the type of growth rates that we're aiming for, but we're going back in defense in this segment for sure.

Before we pivot away from financial results, one last question. Neuroscience was, I guess, I'd say, a laggard in the last quarter with 3% growth. What do you think that looks like in the future? And where does it go from here?

Yes. I think, as I said, we've had a lot of product releases in every segment of neuroscience. Spine did very well with Stealth AXiS. Some of the other segments were a little bit slower in the first quarter. I think you're going to see acceleration in particular, in the second half of this year. Neurovascular has a fantastic product pipeline. We've made a couple of acquisitions. These will be inorganic for 12 months, and then they'll kick into the organic growth after 12 months, and we look forward to that.

All of these acquisitions that we've made, we've made them in areas where the CAGR is sort of north of 20%. So they will accelerate our WAMGR. And so look, again, intrasaccular device, Artisse, and neurovascular, Onyx, which is MMA, Neuroguard for carotid Scientia acquisition. In the neuromodulation portfolio we made the acquisition of SPR and made an acquisition in BVNA and peripheral nerve stimulation. So -- and then in Pelvic Health, you already for the acceleration of the first quarter Pelvic Health, thanks to Altaviva was up 15%. So that's headed in the right direction. So we see that business accelerating in particular, towards the second half of the year.

Okay. Great. Yes. One theme we've continued to see in med tech is separations or portfolio rationalization. I'd say in contrast to many of the companies I cover, you actually spun out or separated one of your fastest-growing businesses. How do you think about separating that versus slower growth? And why did you choose MiniMed for that transaction?

We chose MiniMed because it's different. We're B2B, generally speaking, and MiniMed is B2C. So sort of the product cycle is different. Candidly, it's a great business, but the return on investment is lower than what we have on the rest of the portfolio. So margins are lower. And the amount of spend in R&D as a proportion of revenue is about double the rest of the portfolio. So clearly, it's about being able to invest in cardiovascular med-surg and neuroscience, where we get better returns. We also think that the fact that it's different is going to appeal to different types of investors, right? So we wanted to give MiniMed an opportunity to do its own capital allocation and attract its own investors.

And look, we did the IPO back in May, and I think it's good to see that the stock has performed well since then, especially over the last couple of months. And we just launched the second part of the operation yesterday, and we look forward to see the results of that.

Good. And I guess why not because the stock has done well, as you said, why do...

I think we had announced that we would do it within a relatively on time frame after the first page. And yes, look, it's -- it's performing well. Q4 numbers for them were great. Q1 numbers were even better. The innovation cycle, every product launch is happening earlier than they expect. So they're on a role from an innovation perspective. So the business is doing great and it's the right time to do it. And again, the strategic rationale hasn't changed, right? We want to focus the rest of Medtronic on the rest of the portfolio, and that's where we want to put our efforts.

Which leads to the obvious question, now that you've done that, as you look at the rest of the portfolio, is that the portfolio that we expect in the perpetuity for Medtronic? Or should we expect additional spins or divestitures? How do you think about that portfolio?

Perpetuity is probably a little longer than my horizon. But I would say for the foreseeable future, we like the portfolio at a macro level. That being said, there's more to portfolio management than just these big moves, right? It's also looking at it at a detailed level and I know we formed a growth committee and the Board, and that's one of the key topics that we talk about 5 times a year, we go through the entire portfolio, look at what's growing fastest, slowest, where we have the biggest right to win and we decide where we want to add. And you can see that with some of the M&A and sometimes where we want to trim and we'll keep doing that. And I always give an extreme example, we even do that at the SKU level, right? So in 2026, we retired 25,000 SKUs.

In the first quarter of this year, we retired 9,000, right, which is a large number. So we're systematically going through SKU by SKU, what's a good business, what's not a good business, how can we optimize, and we'll keep doing that. But I think macro level, we like where we are.

Right. The flip side to divesting businesses obviously buying businesses. And I'd say in my career, I've never seen Medtronic as active as you all have been this year in M&A. Do you expect that to continue? And as we think about focus areas where you will deploy capital, any -- you talked about structural heart already, but any other areas that you're particularly focused on?

Yes. So in all fairness, we had kind of stopped for a while doing a lot of them doing M&A, almost since Covidien. And the reason was we were improving operations internally. The operations are a lot stronger now. Manufacturing is humming, logistics is humming, R&D projects are coming on time, et cetera. So we thought the organization was ready to take on new inorganic place. So we've opened that activity, again, pretty significantly, as you mentioned last year, we -- in total, we made, I think, 16 investments. We spent over that 12 months about $2.7 billion. It's about accelerating innovation. So if you look at the last 4, 5 years, we were doing sort of $2.5 billion of R&D and $400 million, $500 million of acquisitions. And right now, we're looking at around $2.9 million of R&D and between $2 billion or $3 billion of acquisitions.

So we're going from $3 billion to $5 billion, $6 billion, right, in terms of total level of innovation. And look, it's with a view of accelerating growth opportunities and moving forward. So we look for sort of what we call tuck-in acquisitions, so where it sufficiently derisked that the outcome is relatively certain, right. But not necessarily fully commercial yet, so that we're not paying the full price. And that's the type that we've targeted with Scientia with Cornerstone, with SPR, et cetera. And we like that.

We're also doing a lot of ventures way upstream, but we like this tuck-in concept. So no sort of $4 billion, $5 billion acquisition. But these kind of $500 million to $1.5 billion, we kind of like that sweet spot.

When you do 9 or so, I think you've done this year, I could be off that are not fully commercial, your words not mine, they're often dilutive. What's the mentality for kind of managing that earnings dilution?

Yes. So look, we embedded in the algorithm, okay? So the algorithm is accelerate growth to get better leverage, work on gross margin, and we've got a lot of opportunity from a gross margin perspective and take what's going to come from gross margin improvement and growth and reinvest a portion of it into innovation, whether it's organic or inorganic, and we embed that in the guidance. So this year, we had embedded the dilution that is going to come from the acquisitions that we've made. We had taken a security in case we were going to do Cornerstone.

And so that allowed us in the first quarter to raise a little bit of the guidance despite making a large investment, and we'll keep doing that.

On outlook, you obviously, as you mentioned, thought you could apply some of your lessons from the automotive industry back in the MedTech with your GE background. Has that come to fruition? And do you think there is meaningful margin expansion within med tech within more Medtronic?

Definitely. And so look, if you kind of peel the onion a little bit, there's 2 parts, the kaizen stuff, what I call the kaizen stuff and the breakthrough. The kaizen is what we do on a day-to-day basis to improve operations. And so if you look at pricing through better contracting, better FX management, more innovation. We turned pricing from being a typical 1- to 2-point headwind to being a 1- to 2-point tailwind. So that brings us 30 to 40 basis points of gross margin per year.

We look at cost and by running the plants better, managing our suppliers better, we typically get net of inflation, 1 or 2 points of cost down now. And so that's another 30 or 40 basis points of gross margin improvement. Today, that's being offset by mix from diabetes and CAS, but those effects are going to go away for diabetes with the separation and for CAS with the growth of the catheter part of the business.

So those kaizen savings in pricing and cost out are going to start showing up, right? But on top of that, One of the things that automotive does different is design cost. So it's all about instead of trying to squeeze 3%, 4% from your suppliers every year, right? It's about designing the product right upstream in the development cycle. When you do that instead of getting 3% or 4% per year, maybe you can take 20% or 30% out of the cost out by involving your supplier in the development process.

So instead of saying, "hey, we want you to manufacture this." And they have to scramble to make it, invest in equipment, et cetera. If you involve them, maybe they can use things that they already do. They can use critical mass and all that. So you get a much better cost position from the start. And so we're making a lot of progress into embedding this design to cost mentality in the new products that we're designing now.

So it's going to take more time if it's going to come as we launch the new products. but it's a much bigger opportunity from a profitability standpoint than what we've pursued so far. So I'm excited about that. The North Star for the team is ultimately to get back to gross margin levels close to where they were pre-COVID, which is about 4 points more than what we're doing today. right?

On fiscal year '27 revenue guidance, what are some of the puts and takes kind of to get there?

So look, so we did about 7% in the first quarter. We've guided for sort of a midpoint for the full year, that's about 7.5%, including the extra week. And so what you're going to see is continued strength in the core cardiovascular business. So it's been a double-digit growth portfolio for us for a couple of quarters now, even outside of the extra week, and it's going to continue to be that way.

The comps are going to get a little harder, especially on the cardiac ablation side, but it's going to remain very, very strong. As I said, neuroscience should accelerate in particular, towards the second half of the year, and that's really driven by the innovation that we mentioned. And MedSurg is humming, right? The surgical business is doing well. The ACM part of that portfolio was exceptionally strong in Q4 and Q1. So we've got a little bit of one-off there. So that will kind of normalize a little bit towards the end of the year.

But Hugo is going to have an increasingly good impact. So I think we're -- you should see a lot of consistency versus what you saw in the first quarter. And again, with a lot of runway on the different growth drivers starting to kick in as we go through the year.

I guess probably have time for 2 questions, so let me pick with the ones I focused on here. The durability of normalized sales growth in the 6% range. What are -- what gives you conviction that -- obviously, you've improved growth at a level I've never seen at Medtronic before. How does that continue into the future be a differentiated grower.

So first, I don't want to spoil the suspense so we've got a big Investor Day coming in December on the 10th and 11th, and that will be a key topic, right, because that's the #1 question we get from everyone is have you made that growth sustainable? But without spoiling everything, it's back to this concept of the base has become stronger CRM, CST surgical to innovation. And then we've got these 4 generational growth driver that are each at a different stage of development and that are kind of take over from each other, right? So that's the basic algorithm and look forward to going into the detail on that in December.

And then -- as I think about it's a different company than it's been in the past. How do you -- how is your -- if at all, your capital allocation priorities change between organic, inorganic, return of capital to shareholders? How do you think about that algorithm now?

Yes. So I think, first of all, we're committed to the dividend. So no change from that perspective. But then on the organic versus inorganic, look, as we said before, we're accelerating inorganic for sure. So it's -- again, it's a way to, in some areas that we think are going to be future meaningful growth areas, having 2 shots on goal, maybe doing -- having an organic program and then doubling it up with an inorganic one or having 2 inorganics. And we like that. If you look at our cardiac ablation portfolio today, it originates in 1 organic program with PulseSelect and on inorganic with Affera. It turns out both of them worked. So we love that. And we're going to try to keep doing that going forward. So -- that's really the big changes accelerating the M&A side of the equation.

Great. We have a minute left. Any last words you want to leave investors with your thoughts on the company?

No, look, I mean I think we're -- it's been a long time coming, and I think it's a testament to the efforts that the team has put in place to improve operations and invest in innovation for many years. But we're at a point where we've got this depth of innovation and the breadth across the portfolio. And that's what's changed, right? And that's ultimately what's going to make this growth acceleration be sustainable. And that gives us an opportunity to change the game from a leverage perspective on the income statement. So we want to be an and company, our growth and leverage from an EPS perspective, and we're super focused on that.

And again, we're going to go through the details of that in the Investor Day, and we'll have 2 days, right, in the evening before the actual event. We'll have a show and tell where we'll show some of our key products with some of our key leaders in the business. And then the next day, we'll have the proper event and should be great. It looks great.

Well, thanks for joining, and we're looking forward to the Investor Day.

Thank you. Thanks, everyone.

Welcome to the stage, Chairman and Chief Executive Officer of Medtronic plc, Geoff Martha; and CFO of Medtronic plc, Thierry Piéton; and Managing Director and Senior Equity Research Analyst covering medical technology, Larry Biegelsen.

Okay. Well, welcome, everyone, to the 21st Wells Fargo Healthcare Conference. I'm Larry Biegelsen, the medical device analyst at Wells Fargo. And on behalf of the entire research team, I want to thank everybody here for helping make this our most successful health care conference to date. We had about 2,000 people register, over 300 companies attending, a great turnout.

So now let's turn to our keynote speaker, Geoff Martha, the CEO of Medtronic, the world's leading medical device company. Geoff is also joined by Thierry Piéton, Medtronic's CFO. The format is going to be moderated Q&A. We'll spend the first part of the discussion on industry trends, and then we'll turn to Medtronic-specific topics. So Geoff and Thierry, thanks so much for being here and agreeing to be our keynote speaker today.

So let's jump into questions.

Sure.

So Geoff, we've seen a rotation out of health care and out of medtech in recent years due to high growth -- into high-growth areas like AI and technology. As the industry leader, Geoff, why is this a good time to invest in medtech?

Well, first of all, Larry, congratulations on that conference. It's great to see it continue to grow, and thanks for having us. Look, I think it's a great time to invest in medtech. I mean, because -- look, we see some really great innovation happening, not just in the traditional biomedical engineering side, less invasive devices, smaller devices, longer batteries, et cetera. But when you take the AI and robotics, they're like force multipliers. And they've allowed us to expand our scope of innovation from not just improving patient outcomes, but to lowering cost over time and also expanding access. And so I think it's a great time to invest in medtech right now.

And we're pulling -- when you look at -- and we can go through this, when you look at our growth, the growth acceleration at Medtronic, a lot of it -- yes, some of it's market share, but a lot of it is expanding the markets and pulling new patients in. In some cases, it's brand-new segments like renal denervation or hypertension. But in other cases, it's just like lowering the threshold for 75-year-old businesses like cardiac rhythm management and expanding those markets and pulling more patients in above and beyond any kind of impact from chronic disease, rising chronic disease or aging population. When you even factor that out, we're still pulling a lot more patients into some new therapies.

That's good to hear. So Geoff, as you know, a concern right now is a potential impact to procedures and capital equipment spending from some of the policy changes going on. What's your -- how are you thinking about the impact?

Well, the policy change I hear the most about would be like the ACA rollbacks. And look, we've looked at that, a couple of things because we've seen some of that commentary. Our -- first of all, our procedural mix is very acute, right? So that's one piece of it. We're not into these more elective procedures. We don't have as much exposure to that. And when it comes to ACA, linked to that acute nature, like we -- maybe 2/3 of our payer mix is Medicare, 25% commercial and less than 10% Medicaid. And when you look at our exposure to ACA-related programs, over -- it's less than 1% of our revenue globally. So it's just not a lot of exposure to it.

That makes sense. And you touched upon, Geoff, AI, which is transforming many industries. What impact is AI having across the industry and at Medtronic? What does it mean for revenue and for costs?

Well, look, I'll start on the revenue side. It's definitely having an impact on our revenue. Again, when we talk about AI, and like I said, especially when you combine it with robotics, but even by itself, it's a force multiplier. And when we talk about AI in our products, we're largely talking about, look, we have a lot of access to structured physiological data, structured device data, procedure data. This isn't -- we're not talking about large language models and just general data. We're talking about very precise data, and we're using that more in a machine learning environment. And it's dramatically impacting like our ability to diagnose things earlier, better to -- here's the big one, to personalize therapy at scale. So whether it's personalizing your DBS therapy, personalizing like a surgical plan and spine for one patient, you're able to do that at scale, and that's going to help little clinical outcomes.

And then as I said just a second ago, it's helping us expand our aperture on what the benefits of the innovation to like talk about access. Take our -- like I just saw this example the other day, our GI Genius for colonoscopy, that's AI in the colonoscopy procedure. Yes, it's -- in the U.S., it's quickly becoming the standard of care because we found in our clinical trials that anywhere from 25% to 50% of the polyps are missed in the leading centers in the U.S. Went over -- and so this -- we erase that, right? It fixed that with the GI Genius that we have.

Go over a place like India, I saw a massive hospital with hundreds of people in the waiting room getting colonoscopies. Here, what we saw is like very young physicians and the CEO of the hospital said, look, these physicians are right out of med school, don't have the apprenticeships or the fellowships that you have in the U.S., but they're getting the exact same diagnostic yield as you're getting in the U.S. because of GI Genius. So it provides good -- it democratizes good care.

That makes sense. China, Geoff, as you know, has been very volatile in recent years. I think you've said in the past, it's maybe 6%, 7% of Medtronic sales. I don't know if that's still the case. How are you thinking about -- what's -- how is your business performing in China? And how are you thinking about that geography going forward?

Well, the percentage of our revenue has come down after the VBP, but it's stabilized. And look, we view China, it's performing well. It's a growth market for us. There's still a lot of -- the Chinese government is very focused on expanding health care to people that don't have coverage in more higher-end health care that we play in, right? And they're serious about it. There's a lot of growth there. And it's a growth market for us, and it's a good profitable market for us.

If it's growing and it's a growth market for you, you're in the minority right now. I think for most medtech companies, it's probably been less of a growth market in recent years because of VBP.

Well, look, in recent years, like I said, it's come down as a percentage of revenue. It's more -- the VBP is more baked into our growth rate.

Yes. I mean we've come down to between 5% and 6%, but it's still a good contribution for us. And the VBP is mostly behind us. So now we're back into a normal sort of environment.

And you're committed to China going forward still?

Yes. Yes, we are.

Okay. Because I think we've seen some companies maybe pull back in recent years. Geoff, innovation is the lifeblood of the industry. You talked about it earlier. What's the state of innovation in the medical device industry today? And what are the areas you're most excited about?

Look, I said before, I think the state of innovation is strong. I mean you're seeing -- I know that there's concerns on procedures and things like that. We're just not seeing it. We're seeing strong procedure growth. You got the rise of chronic disease, you got the aging demographics. But like I said earlier, above and beyond that, our markets are responding well to innovation. We're pulling in patients that otherwise would not be treated like with our Altaviva device for overactive bladder. These patients maybe not seek treatment. But now that you put this just below the skin on the ankle, this is opening up -- pulling more patients into medtech. There's like 16 million patients in the U.S. that's suffering from overactive bladder.

This thing has turned around our Pelvic Health business or you're bringing in them from where they were using a pharma solution like hypertension, right, as we -- or renal denervation or AFib like PFA, right? That's the industry -- there's a couple of players there. PFA pulling people off of drugs and doing more of a procedure. So I see more and more of this. And then you've got, on top of that, the AI and the robotics. And as we -- robotics is -- look, we think about it in the context of the United States. And it's clearly a huge trend in the U.S. But outside the U.S., like in emerging markets, robotic surgery is less than 1% penetrated.

And I do believe the combination of AI and robotics is going to change the way these countries train their physicians. We're not going to replace physicians anytime soon, but like having a driver assist, the digital platform that's the heart and soul of that robotics ecosystem is going to, like I said earlier, democratize good surgery. And that's what I think is going to be an important part of emerging market growth where they just don't have -- there's a huge labor issue, trained physician issue.

Are there areas that you're excited about that you can share with us today that you're watching that you're not in today?

Larry, you're going to have to come to our Investor Day to hear more of that in December in Charlotte, North Carolina. We're going to be having it at the IRCAD facility. And one of the main things we're going to get into there is new growth drivers. But I'd say, in general, like there's a lot in the neurotech area that we're excited about, that's net new to, I think, medtech. And we have -- within the medtech, we have the broadest and the deepest. We're literally #1 in every single area of neuro. And so we're excited about that.

But then there's a couple of areas that we're not in that we still like IVL and a few -- these high-growth areas that we're not in that would fit in our portfolio. We're not looking at hips and knees or anything like that. It's not high growth. But we're looking at these high-growth areas in cardiology that we're not in today. So we'll continue to look at those.

Got it. That's helpful. And I want to talk about the Investor Day later in the conversation. The first one you've done in, I think, 5 or 6 years. Thierry, is that right since 2020?

Yes, 2020, I think.

Yes, 2020, yes.

But first, maybe let's talk about the start that you had to your fiscal year. You're on a fiscal year basis, you reported the Q1 results last week, I believe. Strong growth, I think, 7% organic. I think you said something to the effect that Medtronic is at an inflection point. So just talk about the durability of the growth that you saw coming out of Q1.

Do you want to take this one?

Sure. So okay, thanks. Yes, it was indeed a good quarter. So it was 13.7% with the extra week, about 7%, if you correct from that element. Look, one thing that you might have noticed in the Q1 earnings release is we talked about the big franchises first because we've got a lot of questions around cardiac ablation, around hypertension, et cetera. But we wanted to make a point that, first of all, our 3 franchises are growing significantly faster than they used to.

So you take cardiac rhythm management, one of our biggest franchises in the portfolio. A lot of the competition considers this to be a pretty stable, low single-digit market growth. We were up 15% in the first quarter with the extra week, so about 9% corrected from that. We saw super strength driven by innovation. So EV ICD was super strong. Everything around conduction system pacing was very, very strong, up strong double digit. And we saw even leadless pacemakers, technology that we launched over a decade ago, be double digit.

So we continue to see strength in CRM. In our CST, in our Spine business, large franchise, same thing. Stealth AXiS has enabled us to offer a full suite of products to the customer from navigation, visualization, robotic assistance. It's made the implants a lot more stickier, helped us from a pricing perspective. So that franchise now big capital-efficient franchise performing super well. And our surgical business has performed very well, including acute care and monitoring. So the big franchises were strong, and they continue to accelerate.

And on top of that, we've got these 4 super high-growth areas between cardiac ablation, Symplicity with hypertension, Altaviva in urge urinary incontinence and Hugo in surgical that are each one of them multi-billion opportunities going forward. So that's kind of the algorithm going forward, strengthen the base with big super penetrated franchises in which we protect the physician with innovation and then 4 large franchises at different stages of development that generate more growth going to that. This -- as Geoff said, this will be a key element of our Investor Day in December. We'll talk about the dynamics of how that's going to unfold over time.

And you asked about the durability. Just to build on what he said, everything he just said, I just want to point out that effectively, we've doubled the investment in innovation over the last couple of years because we've really ramped up the M&A machine, so venture investments and M&A to go with our organic. And when you do the dollars, it's effectively doubling our investment in innovation.

And I would point, like we've talked about breadth and depth. So we're like, to his point, the breadth of the growth, the big businesses and all the businesses, also geographically dispersed growth. And now you have -- and you have the growth drivers. And then we're a mix of organic and now inorganic. So we're not relying on one thing. We're not relying on just inorganic. We're not relying on just one country. We've got breadth and depth, no matter how you look at it. Geography, business-wise, growth drivers, inorganic versus organic, it's breadth and depth.

That's helpful. It's hard not to ask about cardiac ablation. It is driving a lot of the growth. 88% growth, I think, a $2 billion business today.

Are you one of the ones that said we wouldn't get there in time? I can't remember.

No, that was someone else.

There's a lot of people that said -- yes, we said we're going to be $2 billion, and people laughed. And we beat that expectation by a lot. So...

Congratulations. So how are you thinking about -- at some point the business slows, law of large numbers. Thierry, you said you're going to grow more than 2.5% of the market in 2020 -- fiscal '27.

2.5x the market.

Right. So just maybe put a finer point on that. How fast do you think the market is growing? What's more than 2.5x mean?

Yes. I mean, look, what we see in the market from a market growth rate perspective is mid-teens, around 15%. So you can do the math. The comps get a little bit harder during the year because we're lapping quarters where last year, we were already up 70% or 80%, but we'll be up 3x the market -- over 3x the market rate in the second quarter and around 2.5x market rate on the full year.

So look, it's early innings. We still have a lot of opportunity, commercially speaking. In the U.S., we're mostly focused on large accounts at this stage. And even those large accounts, they want to grow their installed base. So we're growing internationally. We launched in Japan. We're growing -- we're adding indications. We added ventricular tachycardia in Europe this quarter, and we're applying for it in the U.S. And we've got -- we're not stopping that from a portfolio perspective. So today, Sphere-9 is our main workhorse, and that's driving a big portion of the growth. As you know, we've got 3 -- Sphere-360 coming up. It's now launched in Europe. And it's going through clinical trials in the U.S., and that will be the next stage driving growth.

And in addition to that, you probably saw us make an investment in ICE. So we're trying to surround the electrophysiologists to have the full pictures. But clearly, for us, we're still in very early innings for this business. I think the one thing to keep in mind short term is we grew the installed base of capital equipment by 40% in Q4 and by 35% sequentially in Q1. So just in terms of the pull-through of catheters that that's going to generate, it's super good news for us going forward.

Geoff, what can Sphere-360 do to your cardiac ablation franchise? Why is that an important pipeline product?

Well, look, as you know, the single shot. Right now, Sphere-9 has been a class all by itself, a dual energy, large tip catheter in the point-by-point space. It's by itself. That's one of the reasons, plus people, the maneuverability of it. Sphere-360 goes right at the heart of all of our competitors. And we think on the single shot, and we think it's a better mousetrap and the large tip, the maneuverability of it. We think it's going to be a winner. And it's going -- again, it's going right at the competition. And it's got -- as you know, it's got very -- it's very fast. It's very fast.

So if you're going for efficiency of single shot, this is going to be your tool. And as Thierry said, I mean, it's -- we're not -- we realize how competitive the market is. It's a very attractive market. We realize how competitive it is. We fought like hell to get to where we are, and we're not resting on our laurels. So Thierry just walked through all the things that we're doing, making these investments. We're looking ahead multiple quarters, multiple years, building around the procedure.

And on top of all that, like in the U.S., we're still in these large centers. We haven't really expanded to the medium and smaller centers. And to help do that, we've combined our cardiac rhythm and our CAS sales leadership to leverage those relationships. We've got -- we're everywhere in cardiac rhythm. Our market share is at an all-time high. We're everywhere around the world, and we're going to use that business to help us ease into those relationships around the world. So we've been building for this.

That makes sense. The time line for Sphere-360 in the U.S.?

Well, we just wrapped up the enrollment in the clinical trial. I believe that's a 12-month follow-up, and then we'll submit. So...

That's helpful. Right, so let's switch gears, talk about the soft tissue robotics or robotic-assisted surgery, as you call it, RAS. Big news on the Q1 call last week, $700 million investment and distribution agreement with Cornerstone based in Hong Kong. It gives you rights in select international markets. Talk about the rationale for that deal, please?

It gives us rights in 50 countries, right? So it's a lot of countries outside the U.S. Look, we're doubling down in the robotics. We're not -- outside U.S., particularly in certain markets, our customers wanted more choice in terms of various different things. And Hugo, the focus is on developed markets. This offers us more choice outside the U.S.

Remember, outside the U.S., our market share is disproportionately higher. I mean we're -- there's not nearly as many -- a lot of the competitors you hear about here in the U.S., you don't see them outside the U.S. It's really us, and we're dealing with health ministers. It's socialized medicine. It's controlled at the country level, and they want an offering. And we weren't going to be there, and we have a big surgery business. Surgery is our biggest business in emerging markets by far. But everyone does surgery, open and lap, everybody. If you're going to have a hospital, anything in health care, you're going to have a surgical -- we're by far, us and J&J are the biggest. And this gives us an opportunity to introduce robotics to these customers. So look, the leader in the space, we've got a ways to go. But we are miles ahead of the next guy, and this extends our lead.

So what is it about Cornerstone's Sentire robot that's more amenable to these emerging markets that Hugo doesn't provide?

Well, we're going to have a -- we can have a tiered approach in terms of various things, but that's one. And it's designed for those markets in mind. It was designed in Asia for those markets. So there are different preferences. There are different needs. It's got its own set of instruments. It's got real small instruments, like 5-millimeter instruments, 8-millimeter instruments. And it's a different design than Hugo. So there's a preference sometimes for that. So it just gives customers a choice.

But there's -- when you say tier, do you talk about tiered pricing?

There'll be tiered pricing, tiered offering, yes.

Got it. And how do you see the relationship with Cornerstone evolving over time?

It's early. We'll see. I mean we've been with them for a year, first of all. We've been over a year, we've been working with them. We've seen the robot. They've had thousands of cases. The quality is there. The technology is good. It's really good. And the management team is A+. I mean these guys are very professionally run with -- sometimes these emerging market companies, it's one founder who's also the lead inventor and engineer here. They've got just a great bench. And so we'll see. But right now, the focus is on -- we're both at important moments like in the U.S. for Hugo, we've got new indications coming. We'll cross 50,000 cases by end of the year, 250 unit installed -- installations around the world.

We've got new instruments coming. We've got these 2 new indications in the U.S. are important, and it will make it more of a workhorse. So that's where we're focused. And Sentire is starting their launch, right? They're going to be starting their launch and they're more focused outside the U.S. So that's the focus right now. We'll see where it goes.

Just last question on this. So Hugo is your U.S. surgical robot. The U.S. is still the biggest market for surgical robot. When does Hugo start moving the needle in surgical and for total Medtronic? You gave us some numbers, but we don't know the baseline.

Yes, we haven't gotten -- I can tell you this is already having an impact on our surgical business. You're seeing it accelerate. I don't know if you want to go any further.

No, yes, we haven't given specific numbers on it, but it's already having an impact on the surgical numbers for sure. And look, it's super encouraging. As Geoff said, 50,000 procedures in the year. We'll end the year with about 250 installed robots out there and build from that. And we'll generate pull-through from an instrumentation perspective. It's -- yes, there's numbers...

Accumulated though, 250 placements globally, over 50,000 procedures cumulative.

And yes -- but the thing is we've had a pretty controlled launch here. When you don't just launch a robot, right, an approval is one step that you need. You need reps. You need to be out there and seeing how these things perform in the wild. We learned that in the spine space. The Stealth AXiS is our third generation. Mazor had 2 generations, and this is our third. And you continue to improve performance. And in Hugo, we've done a number of software updates. And look, we're getting great -- like we are like a 99% uptime in the U.S. That's really good.

And so we're very encouraged by the actual performance of the robot. And we've kind of learned along the way and made changes. And that's why we feel really good because like unless you have those, I'd be surprised if some new player comes in and launches a robot, and all of a sudden, it's just excellent in everything. It's going to take time. So we're -- we feel very optimistic where we are on Hugo.

That's helpful. Let's switch gears to the portfolio. Maybe a question for Thierry. Basically, if you sell the MiniMed stake before the end of the fiscal year, how should we think about the accretion? Is it still maybe $0.01 to $0.02 a month?

You're talking on '27 numbers. I think it's highly dependent on the time that we would do the separation. So the way the math works is when we separate fully, then we don't consolidate their profit. So we lose the profit that they generate. But on their flip side, as we exchange the shares, we do a share count reductions. And so mechanically, you get an increase in EPS that comes. It's highly dependent on the timing in which you do it, even within a quarter because there's a hockey stick in MiniMed sales. At the end, it's not -- it wouldn't be a very material impact to our guidance. When we do the separation, obviously, we'll disclose exactly what the impact will be.

The guidance assumes you have it for the full fiscal year?

Yes, that's correct.

You're saying if you did it, say, 3 to 4 months before the end of the fiscal year or 6 months, you're saying it would be fairly immaterial to EPS?

The later you do it, the less benefit you get from the share count reduction. The earlier you do it, the less profit you consolidate. So it kind of balances out. Net-net, it's not a huge factor, but we did take a conservative option of considering that we would keep it for the full year. And look, it's great to see that MiniMed is doing well from a business perspective. They had a good Q4.

Q1 was even stronger. Their volume is picking up in the U.S. pretty significantly. They're on fire from a product schedule perspective. All their innovation is coming out ahead of time. And I think The Street is starting to see that. The stock has been up. It's the best performer in medtech since the 1st of June. The stock is now above the price point when we did the IPO. So it's good to see the business performing, and we're encouraged by the way the way it's going.

The intent doesn't change, though. Part of this improved performance is, we can already see the benefits of them running the business separately. And so we're committed to making that change.

Yes. We're -- like I said, the intent hasn't changed. We're moving forward with this transaction. He walked through the timing. But like I remember when I first started as CEO, there was a lot of questions around diabetes, and we said we're going to fix it and get it humming and then make a decision from a position of strength, not weakness where we were 5, 6 years ago. Financially, that made sense, but also for the diabetes patients, MiniMed is too big of a player in the type 1 space to not get it back to health. And it's now really in a great position.

So Geoff, you can imagine where I'm going with the next question on Medical Surgical. The Cornerstone investment is significant, $700 million. The investments you've made in Hugo are significant. You've disclosed some information about how expensive that program is. Why wouldn't it make sense to also separate that business?

It has a lot more synergies with Medtronic, right? I mean first of all, it's a hospital-based or even as it goes to ASCs, it's a health institution-based business versus diabetes being direct-to-consumer. So there's a lot of synergies, like I just said, in the U.S., outside of the U.S., where we're dealing with these governments, right?

The other -- yes, so we feel like there's a lot of synergies with the U.S. And I think, look, robotics is an important component for us. Again, if you take a step back at Medtronic, we do 2 things from -- one is devices, pacemakers, spine implants, et cetera. And the other is surgeries and procedures, right? And robotics is going to be -- is critical. It's in the early innings to all surgeries, and it's going to move more and more into interventional procedures. You may not have a big mainframe robot, you may have smaller, but robotics is a secular -- is a trend in medtech, and it's important that we become a leader in that space.

I think the concern is just that it's so expensive, soft tissue robotics and you're doubling down. That was your words on the Q1 call. The concern would be that it's taking capital away from cardio and neuroscience, which also require a lot of investment.

Well, look, we have -- we've also gotten a lot of feedback that you have a healthy balance sheet, use it, right? We have strong cash flow, healthy balance sheet. That was a balance sheet investment. And we're not constrained in that way.

Okay. And look, it's good news financially speaking, right, because we're through the distribution agreement, we'll do some sales of the Sentire product, get a margin on that and then it will help improve the financial profile of the med-surg department or second or...

It's accretive to the surgical business. And you got to remember, like it helps cement our business. Remember, the surgical business is our largest. Outside the U.S., it's more or less -- Intuitive is gaining traction with robotics, but it's outside the U.S., there's a lot of big contracts for the surgery business that goes between us and J&J and contracting across open, lap and now robotics is a big deal. And we're the only company that can do that.

Got it. All right. Let's switch gears. Just we've got about 15 minutes left, talk about some of the growth drivers. Renal denervation for hypertension or high blood pressure, a huge market. You talked about it annualizing at $100 billion (sic) [ $100 million ] exiting, I think, fiscal 2026. How are you thinking about the ramp going forward? Do you have an important meeting coming up in September for a category 1 CPT code? How important is that? And that doesn't go -- if it's successful, that doesn't go into effect until 2028, I think.

Right, right. It's a nice -- it will be a nice add. I mean like because the market development is the piece that we're working on right now. Let me just -- first of all, the product we've kind of skated right past that because the product is doing great. I mean, clinically, the data we're seeing in the wild is dramatically higher than the trial. The trial was designed a certain way. But out in the wild, we're seeing 18-point drop in blood pressure. It's amazing. And patients love it. Physicians are thrilled because they're heroes to these patients that had this intractable problem.

Any kind of procedural concern is behind us, like the anesthesia, that's all dialed in. The product is working great, and it's durable. And I remember there was a lot of people who thought that ultrasound is -- well the ultrasound competitor is not -- we're doing way better than anybody thought from a market share perspective. And the RF is showing durable results where ultrasound is not.

So all ultrasound data, not cherry-pick, but every single piece of published ultrasound data, we have more durable -- so we feel really good about it clinically. And then we're continuing to invest in the product to make it faster, easier, radial access, et cetera. Shorter ablation times, multi-organ investments, so to make it -- so the product is in a great spot.

The market development is what we're working on. And that is more insurance coverage. So we're going to build off that -- and we're building off that national coverage decision in the U.S. Now getting commercial payers to fall in line, Blue Cross Blue Shield and Medicare Advantage plans are all starting to fall. We just got Highmark recently. It's a big payer. There's big ones out there that we need to get and then building out that referral pathway. And that piece -- we now have hospitals more coming to us because the doctors are saying, "Hey, look, I saw the clinical data. It was okay, but this is what I'm seeing in the wild is in my own practice is dramatic." And they're pushing their hospitals into it.

And so they're coming to us. We're working on this. The payers are working on the market development, and we'll start doing more direct-to-consumer here in the fall. Now that we have a little bit more of a base in the U.S. to build on and we'll target a few cities and go from there in addition to the social media we're doing.

This is a $1 billion product for Medtronic.

Absolutely. Absolutely. Yes.

Okay. And maybe we'll get a time line on that in December. Stay tuned.

Yes, stay tuned.

Geoff, a couple of other questions here. TAVR was a growth driver for you for a long time. That seems to have slowed. Can that be a growth driver for you again?

Yes. No, look, first of all, low risk -- the low-risk data that came out definitely muted our growth the last couple of quarters. That's stabilized now and it's been stable for how long?

Since early Q4 of last year.

Yes. So we feel like we've hit that bottomed out there. We're not seeing that dynamic outside the U.S. that low risk is more -- so we're performing better outside the U.S. But even without that, right, I think the bigger opportunity for us is more shots on goal within structural heart. We think it's a growth segment in medtech. It's obviously it is. And we need more -- we've made more investments there. So to get into balloon expanding, we had the Anteris investment. We just announced this Pi-Cardia deal. And look, that helps in valve-in-valve procedures.

It's another tool in the box of ours. We have a strong commercial presence. We're one of the market pioneers. We've got a great reputation. And a good product, we need to build around it. So balloon expanding other tools like Pi-Cardia, we got plays in mitral and tricuspid replacement, and we're going to continue to make investments in the space.

That's helpful.

And with the growth of the rest of the company, we've been able to absorb the slowdown in that.

Maybe I know you brought Altaviva with you. Just talk about what this is doing for your Pelvic Health business, please?

Yes. Well, it was 15%.

It was up 15% in the first quarter.

Yes.

Yes. I mean it's 9% underlying.

Sorry?

15%, including the extra week.

Yes.

So 9% underlying.

9% underlying. Yes.

And that would have been flat, right? And you see our competitors flat. The SNM space has been a little sluggish. I think that will bounce back a bit, but it's -- but this is going to...

Do you think you've turned the corner in Pelvic Health because that's been...

Yes.

A slower growth area for you.

So you'll still -- sacral nerve still has opportunity to improve, but the real story is Altaviva. It's just under the skin above the fascia. It's a very quick procedure. What you're doing is, first of all, you're bringing in a lot of physicians that weren't comfortable with a sacral nerve implant. That's an implant. We need to come up with a better name. It's like an insertion, right, the generic name.

The procedure is not an implant procedure. It's just under the skin, no anesthesia, no imaging, no trial. It's easy. These specialty guys are doing it in minutes. And the patient goes home right away with it turned on. The sacral nerve, you got to test for it. You have to have imaging workup. You have to do a trial. When you get the sacral nerve implant, both ours and the competitor, you have to wait 30 days to turn it on.

I mean there's a lot to it. This is so much easier and there's a lot of patients out there. And it's set it and forget it. You don't have to -- this thing will -- we're debating on the business model. We need to charge it like once a year. So do you -- we just go back to the physician once a year for your checkup. You charge it while you're there for -- in 20, 30 minutes. So it's -- I think this is a great product. And this is an example of us leveraging our breadth technology platforms. This is basically a cardiac rhythm product that we -- the hardware and then we customize the software and built an implant procedure around it.

Spine was good for you this last quarter and that's an elective area. So you're not even seeing softness there going back to the procedures.

No. Spine would have even been better. Quite frankly, you mentioned China. We have -- in China, we're not doing as well. That's our own issue, not a market issue. That's on us. Had that not been an issue, you'd see even more growth. And that business is mainly a U.S. business. It's like 80% U.S. and it's really strong. And as you've seen over the last decade, the enabling technology strategy has really changed the competitive dynamics. You've seen a lot of big name companies get out. It's a lot of investment. It's a lot of expertise to have that enabling technology and makes the implants more sticky, and we believe we're going to get -- we're getting better patient outcomes.

Now capital allocation. You've done -- we've seen a pickup in M&A activity. Just talk about your willingness to kind of accept dilution, kind of what your criteria are for acquisitions.

Yes. So look, I think, clearly, Geoff said, we've accelerated the investment in innovation, and it's been on the organic side, but also in the M&A side. So we used to be running for $400 million, $500 million per year for the last 6 or 7 years. And we've announced, I think, $2.7 billion or $2.8 billion in the last 12 months. So clearly, going back on offense. But it's always with a view of complementing the portfolio in a tuck-in fashion. So if you take Scientia, for example, in neurovascular, it's bringing the access part to the portfolio that we didn't have, complementing the portfolio in neuromodulation with PNS or BVNA.

So it's always with this type of size of acquisition where the risk is acceptable, but it's the perspective of a -- positive financial outcome is there. And we're going to continue to do that. Look, we have -- with the cash that we generate, the cash generation is getting better and better. We're getting close to an 80% conversion on free cash flow now. We have ample firepower to do a meaningful amount of M&A going forward.

From a dilution perspective, look, some of these deals have put some dilution in the P&L, and we embedded that in the algorithm that we have going forward. And we have to offset it with leverage that we get on overhead and improving gross margins over time. So it can't be either/or acquisitions or EPS growth. We have to reconcile both. And that's what we'll do this year, and that's what we plan to do going forward.

So let's talk about the last 5 minutes here, the kind of the Investor Day and the algorithm, the outlook here you talked about. So maybe, Geoff, this is your first Investor Day in 6 years. At a high level, what can we expect? And why did you choose to host the meeting at IRCAD, which is a surgical robotic training facility?

Yes. I mean, look, when it comes to the robotics, both soft tissue and our spine robot and the ecosystem around it, including the digital piece of it, right, you got to see it. You got to see it how the ecosystem works together and to see how the workflow, especially in spine, it's not a collection of products. It's an ecosystem. We branded it AiBLE, and you can see the workflow, you see the digital and IRCAD is set up to demonstrate this to audiences, right? And you'll hear from physicians that are not just -- they work with our competition. You'll get -- you'll hear from them. I think that's more compelling than, quite frankly, in hearing from us sometimes.

And yes, I think we've done this with our Board and other stakeholders, and it really -- it's a great way to see it. And we're going to focus on not just the big growth drivers that you know about, but there's a lot of growth drivers that we haven't talked about that we just don't get the airtime to do that. You're going to -- we're going to talk more about them. And it's a great environment to do that.

Great. And then just in terms of the algorithm, last Investor Day, 5% plus on the top line, 8% plus EPS CAGR. I think this year, it's -- well, it's about 6%, right, at the midpoint. High single-digit EPS growth. Anything -- without giving away exactly what the LRP is going to be, what -- why would it be different from that mid-single digit, high single digit -- mid-single-digit top line, high single-digit EPS, why would it be any different?

Look, that's what we're going to talk about during the Investor Day. So how are we going to make this accelerated growth sustainable? And how are we going to generate leveraged earnings in a sustainable fashion as well? So that will be a key topic.

And anything, Thierry, on like fiscal '28, some of that you have the extra week, you've got a tariff refund. So does that make that high single digit next year tougher?

Look, we'll talk about the '28 guidance later on in the year, but there will be an impact of one less week for sure, mechanically. But we will also have completed the diabetes deal. We'll have sailed past the tariff issue on a consistent fashion. This year, we've got some headwind coming from fuel and things like that. So there's puts and takes, and you'll get more details as we go in the year.

Okay. Helpful. We've got a couple of minutes left. Any questions in the audience we didn't get to? I know there has been a lot of traffic at the elevators. So if I give people 1 or 2 minutes extra to get to their next meeting, they'd probably appreciate it. But Geoff, before we end, I'd love to give you the last word and make any closing remarks.

Look, first of all, again, thanks for having us here. I mean it's -- we're excited to be here. I mean the company is in a great spot. You can see the accelerating revenue. It's innovation-driven. And we see a healthy end market. I get some of the concerns, but that's not what we're seeing out there. And we've got a uniquely strong pipeline, broad and deep and really excited to play out the next couple of quarters and get into the Investor Day and talk about how it's durable and how we're going to drive that leveraged earnings, right, because I know that's something people want to see for sure scale.

All right. Geoff and Thierry, thanks so much for being here.

Thank you.

Appreciate it.

Good morning, and welcome to our fiscal '27 First Quarter Earnings webcast. I'm Ingrid Goldberg, Head of Medtronic Investor Relations. And I'm joined by Geoff Martha, Chairman and Chief Executive Officer; and Thierry Pieton, Chief Financial Officer. Geoff and Thierry will provide comments on the results of our first quarter which ended on July 31, 2026, and our outlook for the remainder of the fiscal year '27. After our prepared remarks, we'll take questions from the sell-side analysts that cover the company.

Earlier this morning, we issued a press release discussing our quarterly results and several financial schedules. We also posted an earnings presentation that provides additional details on our performance. The presentation can be accessed in our earnings press release or on our website at investorrelations.medtronic.com. During today's program many of our statements will be forward-looking and actual results may differ materially as explained in our SEC filings. We undertake no obligation to update any forward-looking statements. Unless otherwise stated, all comparisons are on a year-over-year basis and revenue comparisons are made on an organic basis, which excludes the impact of foreign currency first quarter revenue in the current and prior year reported as other, as well as significant acquisitions, divestitures or other significant discrete items.

As a reminder, fiscal '27 is a 53-week fiscal year with the extra week occurring in the first fiscal month of the first quarter and is included in our Q1 results. References to sequential revenue changes compared to the fourth quarter of fiscal '26 and are made on an as-reported basis. Unless otherwise stated, all reference is to share gains or losses on a revenue and year-over-year 52-week basis, comparing our most recently completed fiscal quarter to our competitors most recently completed calendar quarter.

Reconciliations of all non-GAAP financial measures can be found in our earnings press release or on our website at investorrelations.medtronic.com. And finally, our EPS guidance does not include any charges or gains that would be reported as non-GAAP adjustments to earnings during the fiscal year. With that, I'm now pleased to hand it over to you, Geoff.

Okay. Thanks, Ingrid, and good morning, everyone. Thank you for joining us. Look, Q1 represents a strong start to fiscal '27, with revenue of $9.8 billion and adjusted EPS of $1.45 both well ahead of expectations. Organic revenue growth was 13.7%, reflecting strong underlying market demand and excellent execution across our businesses. Importantly, these results reinforce our confidence in the durability of our growth. Our 3 largest businesses, CRM, CST and Surgical, all delivered strong results this quarter. Cardiac Ablation Solutions continues to perform exceptionally well, and we are making progress in simplicity, Altaviva and Robotics with Hugo. And at the same time, our recent acquisitions are contributing to reported growth and strengthening our portfolio for the long term. So we are executing, and this quarter's results are a clear proof point. Our strategic and operational focus is translating into stronger commercial performance and greater consistency with healthy underlying markets relentless execution and multiple growth platforms, all gaining scale, Medtronic is increasingly well positioned to deliver on our fiscal '27 targets and our long-term revenue and earnings trajectory. So with that, let's get into the details of what drove the quarter.

Starting with Cardiac Rhythm Management, which delivered an outstanding quarter with global growth of 15%. Performance reflected strength across both high-power and low-power therapies with contributions from EV ICD, Micra and conduction system pacing, including OmniaSecure. At more than $5.5 billion in annual revenue, CRM is one of our largest businesses and has been a long-standing source of strength for the company. As an example, Micra, which launched more than a decade ago, continues to grow at a healthy double-digit rate which underscores the lasting impact of meaningful innovation within CRM. And we're not standing still. We are further advancing innovation across pacing defibrillation and diagnostics supported by a strong pipeline and excellent execution from our teams. Look, CRM is a flagship business for Medtronic. And we continue to view this business as a key source of innovation, one that will drive durable growth for years to come. Cranial and Spinal Technologies was another Q1 highlight, delivering 13% growth, including 14% in the U.S. and 10% internationally. Our AiBLE ecosystem continues to resonate with customers as it connects technologies that have traditionally operated in silos. By bringing together AI-driven planning, imaging, navigation, robotics, implants and outcomes data across the surgical journey, AiBLE help surgeons make more informed decisions, operate with greater precision and learn from each and every case.

And our recently launched Stealth AXiS platform also meaningfully outperformed this quarter. While we're still early in the launch, adoption is building and customer feedback has been very positive. With U.S. spine robotics penetration still in the single digits, we see a significant opportunity to drive ecosystem pull-through and extend our leadership position in spine and cranial technologies for years to come. Now moving to Surgical, which delivered another strong quarter with 9% global growth. Surgical is our largest operating unit with over $6 billion in annual revenue. Here, we're leveraging our decades of innovation and operating room partnerships to build a connected surgical ecosystem. And we're going to dive deeper on this in just a few minutes. In addition to these businesses, our next cycle of large growth opportunities are playing a more significant role in our performance. Cardiac Ablation Solutions delivered another quarter of excellent performance further strengthening our position in one of the most attractive markets in med tech. In Q1, CAS delivered 88% worldwide growth, reflecting the team's execution and the strength of our platform. Sphere-9 momentum continued with a 9-point increase in U.S. share during the quarter. And I'm pleased to share that we achieved an important commitment this quarter ahead of the time frame we promised surpassing the $2 billion mark in trailing 12-month revenue.

The broader EP space remains healthy, growing in the mid-teens, and we continue to expect CAS to grow at more than market rate this fiscal year. Our U.S. Affera installed base again grew more than 35% sequentially in Q1, demonstrating that we remain in the early innings of this opportunity. And as we look ahead, our runway extends well beyond today's share gains as we build out a comprehensive EP platform, one that spans mapping, ice catheters, focal ablation software and single-shot innovation, positioning ourselves to serve electrophysiologists with a more -- with more complete solutions and expand the number of patients who can benefit from advanced EP therapies. This quarter, we expanded our offering with CE Mark for Sphere-9 for the treatment of ventricular arrhythmias, including ventricular tachycardia, opening the door to a patient population that is notoriously difficult to treat. And enrollment in our U.S. VT pivotal trial is also underway. We're only at the beginning for CAS with a differentiated platform, a growing installed base, expanding indications and a strong innovation pipeline, we are well positioned to treat more patients to continue to gain share and further extend our leadership in this large and growing market.

Now turning to Symplicity. Q1 was another strong quarter. and we are increasingly encouraged by this market's evolution, real-world outcomes, well, they just keep getting better as evidenced by the 3-year data we recently presented. And we are pleased to share that the SPYRAL AFFIRM clinical trial was accepted for a late-breaker at TCT this fall. Look, the conversations with clinicians is increasingly shifting from awareness to access and more hospitals are approaching us about establishing Ardian programs. Here, our key focus areas are on expanding coverage and integrating Ardian into the care pathway. Looking ahead for Ardian, our transradial catheter remains on track to launch in the second half of this fiscal year. This is an important step forward as many interventional cardiology procedures are performed via radio access today, making the therapy easier to integrate into existing workflows and potentially improving patient outcomes. These positive signals further reinforce our conviction that Symplicity is one of the most compelling long-term growth opportunities in med tech.

Now turning to Pelvic Health. The business delivered strong growth this quarter, increasing 15% and driven by significant progress from Altaviva where procedures doubled sequentially. Demand for Altaviva is building. And while we are still early in our launch, Altaviva is gaining traction with physicians as well as the 16 million U.S. patients who still suffer from urge urinary incontinence. As we continue to expand training reimbursement support and patient awareness, we are really encouraged by the progress we are already seeing. And we are confident in Altaviva's ability to become a meaningful contributor to growth for years to come. Okay. Back to Surgical. We have a strong leadership position in surgery built on decades of innovation, trusted technologies and a long-standing partnerships with surgeons worldwide. As robotic-assisted surgery continues to expand, we believe our portfolio breadth, our global reach and our operating room presence uniquely position us to help shape the future of surgery and extend the benefits of these technologies to more patients around the world. Robotic-assisted surgery, or RAS is one of the most compelling growth opportunities in health care with global penetration still in the single digits and only 1% in emerging markets. At the same time, RAS is in high demand with procedure volumes up approximately 16% per year over the last decade. There is a significant runway here, and we expect robust expansion for many years to come.

Now we've established our foundation in soft tissue robotics with Hugo, where we continue to make meaningful progress. By the end of the fiscal year, we expect Hugo to surpass 50,000 completed procedures with procedure growth continuing at more than twice the market rate. We're also advancing our platform through new capabilities and new indications including the expected U.S. expansions into general surgery and gynecology. We are investing in building out a broader surgical ecosystem just like in CST, an ecosystem that integrates robotics, advanced visualization, navigation, instrumentation and digital technologies, including AI-enabled capabilities like touch surgery. Today, Touch Surgery is used in more than 1,500 operating rooms globally, supporting AI-powered insights, collaboration and workflows. And with Touch Surgery Aid, unveiled at SRS, we are bringing 300x more computing power into the operating room and creating a foundation for increasingly advanced AI capabilities over time.

And now that brings us to Cornerstone robotics. As announced this morning, we are further enhancing and expanding our robotic portfolio through a strategic investment and distribution agreement for Cornerstone's Sentire Surgical System in select markets outside the U.S. into your compliments you go by extending our reach into select international markets and broadening the range of customer needs that we can address as robotic surgery continues to expand globally. So taken together, the platforms, Hugo, Touch Surgery AID, Sentire and our enhanced surgical instrumentation position Medtronic to build a differentiated global robotics portfolio, combining advanced robotics, AI, visualization and instrumentation to push the field forward, improving surgical precision and workflow and serve a broader range of customers and patients around the world. Look, Q1 performance is further evidence that our strategy is translating into stronger results. We are accelerating growth advancing innovation and focusing the portfolio and deploying capital with discipline. Overall, our progress this quarter reinforces our confidence in fiscal '27 and in our long-term revenue and earnings growth potential.

With that, I'm going to turn it over to Thierry to walk through more detailed business results, our financials and our updated guidance. So over to you, Thierry.

Thanks, Geoff, and hello, everyone. I appreciate you joining today. Before we begin, I'd like to remind everyone this quarter benefited from the extra selling week, which we estimate contributed approximately $570 million or 670 basis points to total organic enterprise revenue growth. Excluding the impact of the extra week, we delivered our strongest quarterly performance in nearly 8 years, excluding [ COVID comps. ] Revenue this quarter was $9.8 billion, up 13.7% on both a reported and organic basis. Geographically, we saw nearly 16% growth in the U.S. and 12% internationally. Cardiovascular delivered 19% revenue growth this quarter, excluding 25% in the U.S. and 14% internationally. Electrophysiology therapies or EPT, which includes our CRM and CAS businesses, grew 29%, including 41% in the U.S. and 18% internationally.

Within EPT, Cardiac Ablation Solutions was again a significant contributor, delivering 88% growth, up 139% in the U.S. As Geoff outlined, while we are gaining share rapidly in CAS, this business is still in the early stages of its trajectory. In Q2, we expect to outpace the market by more than 3x with growth rates moderating over the remainder of the fiscal year as we lap increasingly strong comps. Cardiac Rhythm Management was up 15% worldwide including balanced performance between the U.S. and international markets, gaining 80 basis points of global share. Conduction system pacing continues to gain momentum adding over 200 basis points to CRM in the first quarter. As CSP adoption expands across a growing patient population, Medtronic remains the leader with CSP capable leads in both high and low power segments. Our broad portfolio and innovation pipeline, position us to extend our leadership in this large franchise. Pivoting to interventional cardiology therapies, which include structural heart and coronary and renal renovation. ICT grew 7% globally, driven mainly by 11% in international growth. Structural Heart grew low single digits. Similarly to Q4, U.S. procedure volume trends remain stable.

Our internal programs in mitral and tricuspid replacement are on track. And we're taking steps to broaden our opportunity over time through targeted external investments as evidenced by our strategic investment earlier this year in Antares as well as Pi-Cardia announced this morning. Pi-Cardia is the first FDA cared leaflet modification technology for TAVR procedures for patients at risk for coronary obstruction, one of the fastest-growing segments in Structural Heart. Coronary and Renal renovation grew 13% globally. Our coronary business was up low double digits, with Cath works our AI and advanced computational science platform for angio-based FFR contributing nearly 300 basis points of organic growth. In Ardian, we continue to make progress in the first quarter. Positive trends across access, market development and adoption reinforce our confidence in this very large opportunity. cardiovascular surgery, which includes our cardiac surgery and aortic businesses grew 8% globally, and Peripheral Vascular Health was up 11%.

Now moving to neuroscience. The portfolio grew 9% worldwide, driven by 11% in the U.S. and 7% internationally. Crano and Spinal Technologies delivered 13% growth worldwide Performance was driven by continued strength in Core Spine, up 14% and neurosurgery up 15%, along with strong contribution from staff access following its first full quarter since commercial launch. Specialty Therapies was up 7%, including 10% in the U.S. and 4% internationally. Within Specialty, Neurovascular grew 4% globally driven by 9% in hemorrhagic and continued strength across flow diversion, intrasaccular embolization, carotid stenting and access devices. In August, Onyx 12 received U.S. FDA approval for MMA embolization to treat subdural hematomas. All 3 Onyx viscosities are now approved for a 1-minute shake time versus the conventional 20 minutes. This quarter, we completed our acquisition of Scientia, which represents an important advancement in navigation, enabling neuro interventionalists to reach areas of the brain that have historically been extremely difficult to access. Pelvic Health delivered 15% growth globally.

In S&M, Medtronic continues to outpace peers and Altaviva's performance is now more than offsetting S&M market softness. We're pleased with the continued progress in Altaviva as physician training expands, reimbursement progresses and physician experience builds. We expect Pelvic Health to become a stronger and stronger contributor to neuroscience in fiscal year '27 and beyond. ENT grew 7% worldwide, driven by low double-digit growth in the U.S. Neuromodulation was up 3% globally driven by ongoing SCS market softness and replacement headwinds in DBS. Our neuromodulation position has been strengthened by the acquisition of SPI Therapeutics in peripheral nerve stimulation, and through our distribution agreement with Medical which expands our presence in BVNA. Both segments are growing over 20% annually. Together, these strategic actions increased our exposure to attractive high-growth markets and reinforce our broader pain portfolio. Now turning to Medical Surgical, which had a strong quarter and delivered 10% growth globally with balanced performance in the U.S. and internationally. Surgical revenue increased 9% with similar performance across the U.S. and international markets.

We saw strength in Advanced Energy and Wound Management driven by share gains from our LigaSure vessel sealing and VLOC Barb sutures. As Geoff mentioned, we are pleased with our launch of Hugo which had an increase in contribution in the quarter. Endoscopy grew high single digits, driven by further momentum of Endoflip 300 system and of PillCam. Acute care and monitoring was up 14% globally including high teens growth in the U.S. Results were driven by mid-40s growth in McGRATH video laryngoscopy, high 30s in Microstream capnography and high single digits in [indiscernible] core pass oximetry. This performance was a positive tailwind in the quarter. However, we expect ACM to normalize as we move through 2027. Finally, the Diabetes business delivered 15% growth driven by U.S. acceleration and robust growth internationally. Our strategic intent for the separation of MiniMed is unchanged, create 2 focused companies that will allow both MiniMed and Medtronic to execute more effectively, pursue their distinct capital allocation strategies and align with the investor bases that best match their respective financial profiles.

Before we shift to the P&L and guidance, I wanted to spend a moment on what we're seeing in terms of procedure volumes. Now Q1 was a very strong quarter for Medtronic, underpinned by healthy underlying procedure volumes across nearly all of our end markets and geographies. Importantly, this strength was broad-based and not concentrated in any one therapy or region. We continue to see resilient demand across chronic disease, high acuity conditions and life-saving interventions, areas where Medtronic is particularly well positioned given our differentiated innovation and strong clinical evidence. While we continue to monitor the broader environment closely, as usual, the underlying demand backdrop remains constructive and reinforces our confidence in the durability of our growth. Overall, we're pleased with Q1 performance as well as the widespread contribution to revenue from many operating units.

Now moving down the P&L. Our adjusted gross margin was 65.2%, up 10 basis points year-over-year. Now let me walk you through the elements that shape gross margin this quarter. We've maintained our discipline on pricing, which provided 30 basis point benefit to the quarter. Net of inflation, cost down contributed 50 basis points this quarter, driven primarily by COGS efficiency programs and strong execution across our portfolios, global operations and supply chain teams. In Q1, we rationalized more than 9,000 SKUs, further streamlining our product portfolio to focus on the areas with the greatest customer impact, while enhancing supply chain performance and delivering cost efficiencies across the enterprise. Mix was unfavorable by 50 basis points, largely reflective of the diabetes and CAS businesses. Consistent with prior quarters, while the near-term capital mix continues to impact our gross margin, it's reflective of our strong commercial performance and growing installed base, which is expanding our foundation for future pull-through of higher-margin catheter sales over the long term. The tariff-related impact with a slight headwind as tariffs paid were largely offset by related refunds.

And finally, the impact from foreign exchange was roughly neutral. Adjusted SG&A was 32.4% of revenue and increased 14% year-over-year. We continue to make investments to accelerate the commercialization of our growth opportunities, while also integrating several recent acquisitions. Adjusted R&D was 7.9% of revenue in Q1 and increased 6% year-over-year. Here, we are focused on driving sustainable growth through investments in innovation, complemented by targeted inorganic opportunities. This discipline is reflected in acquisitions like SPR Therapeutics and Scientia, both of which operate in markets with CAGRs exceeding 20%. These businesses are demonstrating strong early traction. And while not reflected in our organic growth today, they're expected to contribute over $150 million to inorganic growth in fiscal year '27. Our adjusted operating profit was $2.3 billion and increased 15% year-over-year. This resulted in an adjusted operating margin of 23.7%, up 10 basis points from the prior year, while we continue to invest behind our highest priority growth opportunities.

Our adjusted tax rate was 17.2%, slightly better than expected. The benefit was mostly timing, and we expect this to be offset later in the year. All in, our adjusted EPS was $1.45, $0.06 above the midpoint of our guidance range and of Street expectations. Now turning to our guidance. As a reminder, our full year guidance includes the diabetes business through fiscal year-end. On the top line, we are pleased with the strong performance in the first quarter, and are raising our fiscal year 2017 organic revenue growth guidance to 7.25% to 7.75%, which represents a 50 basis point increase from our prior guidance. In the second quarter, we're expecting roughly 6% organic revenue growth. Based on recent FX rates, we expect foreign exchange to be a roughly $50 million to $150 million headwind for the full year with approximate $25 million to $75 million headwind in 2Q. Moving down the P&L and starting with gross margin. We continue to expect pricing and COGS efficiency programs to offset the current impact of business mix, which is primarily from diabetes and CAS. This headwind is expected to reduce following the completion of the MiniMed separation, which we intend to close prior to fiscal year-end. We continue to make targeted investments that are focused on our highest priority growth opportunities and are intended to strengthen the durability of our long-term revenue profile. Taken together, we expect fiscal year '27 operating profit to grow approximately 10% with operating margin expanding approximately 50 basis points year-over-year.

Moving to EPS. Given the strength in the first quarter, we're also raising our fiscal '27 guidance range to $5.94 to $6. For the second quarter, we expect EPS and in the range of $1.32 to $1.34, which includes a roughly neutral impact from foreign exchange at recent rates. To close, we are well positioned for a strong year. I'm encouraged by the strength of our first quarter performance and the continued progress we made against our strategic priorities. At the same time, our operational focus has begun translating into our financial results. Portfolio simplification, SKU rationalization, cost out, and broader supply chain initiatives are beginning to deliver structural efficiencies down the P&L, and we see further opportunity ahead.

We're pairing that discipline with targeted organic and inorganic investment to accelerate innovation and support commercialization and expand our growth platforms. Look, we are laser-focused on translating stronger growth and enhanced efficiency into durable earnings leverage. With that, back to you, Geoff.

Okay. Thanks, Thierry. Q1 was a strong start to fiscal '27 and another proof point that our strategy is translating into results. What gives us confidence is not simply the strength of the quarter, but also the breadth of our performance this quarter. Growth is being driven by several businesses, multiple innovation platforms and teams who are executing at a high level across Medtronic.

We look forward to sharing a deeper look at our portfolio and our pipeline and our capital allocation strategy as well as our long-term growth opportunities at our upcoming Investor Day scheduled for December 10 and 11. With that, I'd like to thank our Medtronic colleagues around the world. The progress we are making reflects the disciplined focus and execution of our teams. I want to thank you for your hard work and continued commitment to reaching more patients. Together, we bring our mission to life for the people who are counting on us the most.

Okay. Let's turn to Q&A now, and Ingrid, please provide the instructions and queue up the analysts.

[Operator Instructions]

Finally, please be advised that the Q&A session is being recorded. We'll now pause for a few seconds to assemble the queue. Our first question comes from Travis Steed at Bank of America.

Congrats on a great quarter. I guess I want to -- as is doing really well, but I want to spend a second on kind of the Medtronic business ex CAS and just some of the ability to accelerate and improve kind of the base business ex CAS at Medtronic kind of going forward, we saw Altaviva having an impact. So maybe just spend some time on that and also the investments this morning with the Cornerstone deal, when does that show up in kind of the base surgery revenue? And how does that contract structured Cornerstone.

And then, Thierry, I wanted to also follow up the margin guide, I think ticked down like 10 basis points from 50 basis points from 60 to 50 basis points. Just wanted to clarify that if that's because of some of the investments you've done this year.

Okay. A couple of other questions here. Thanks for the questions, Travis. First on the -- I'll take -- I'll start on the first one, just on the business performance and get it ex CAS. I say, first of all, -- what we like about the quarter is the breadth and the depth of the performance, right? You had a number of businesses are -- including our big 3 performed really well. cardiac rhythm and improving performance in surgical. And on that breadth note, a lot of different countries around the world contributed to the growth.

And then as you point out, we had a number of growth drivers on top of this to give you the depth, right? The CAS being the biggest one, but also some good progress in Altaviva, Ardian, Hugo, so we've got these growth drivers all moving forward. So look, from our perspective, the performance is broad-based, and we had strong execution. And it's really -- as we talked about this last quarter, the compounding impact of a lot of strategic operational and cultural changes that we've made. So beyond CAS, like you said, you're getting to your question, like I said, we have these other growth drivers that we're feeling really good about. We can talk about the announcement we made this morning in structural heart with Pi-Cardia as well as in soft tissue robotics with Cornerstone robotics. There's a lot to talk about, and Ardian is making good progress as well. Altaviva is starting to inflect and on top of that, you've got Stealth access, really doing well in CST. So we feel good about these other growth drivers.

But if I go around the horn, I mean, just talk about neuroscience for a second. Lots going on there. I mentioned Stealth AXiS in CST. We talked about Altaviva, we can get more into that. And then in neurovascular, we see an acceleration here in the back half of the year, getting that business to mid-single digit. It's partly the acquisition of Scientia, that's not in our organic growth. And on top of that, we'll get to the mid-single digit. But it is it is getting us into more cases, and we've got a lot of new products there, more indications for Onyx. We've got carotid stenting, and we've got RT. So we've got a number of new products there. they're driving then, of course, in Pain Stim and our Neuromod business, we got the new BB&A partnership. It's accelerating as well as SPR, which is moving us upstream and so that business will benefit from that. So you're going to see a nice acceleration in neuroscience, continued performance in cardiovascular and you're seeing the acceleration in surgery. I don't know, Thierry, if you want to add to that and get to the question.

I would say one thing that I mentioned, you mentioned the different investments that we made. In aggregate, we should expect around $150 million worth of revenue in the full year from these acquisitions with kind of a partial year impact. And it's in organic for now, but it will turn into inorganic for now, we'll turn it into organic. And all of these investments and acquisitions are areas where the CAGR is significantly higher than the rest of the business, right? We're talking segments where the growth is typically north of 20%. So that's further good news down the road. I think one that I would mention, you talked about neuroscience.

In neuroscience, in every single segment, we have meaningful innovation happening. So we have Stealth AXiS in CST. You talked about Scientia, Onyx, Neuro guard, RTs in neurovascular. We've got Stealth AXiS, ENT version for the ENT business and Apex cut that's coming out. So every franchise there has good news going forward. So look, I think we've got a lot of good news ahead of us. And there was a question on Cornerstone, but maybe to talk about the margin question, Travis. There's -- yes, it's really the result of the investments that we're making. So just to talk about the guidance for a moment. So we're raising the revenue guidance by 50 basis points and slightly raising the EPS. The way to think about the EPS raise is we took the upside of the first quarter. And then a couple of things I would say part of it about Ascent is driven by tax, which is timing, which we assume is going to come back the other way. for the rest of the year. We've embedded now in the guidance, the foregone interest that is going to come from the investment that we just made in Cornerstone. So it's a $700 million investment, and we're going to have some foregone interest on that.

And then to your point, what we're doing is we're taking a portion of the upside from a revenue perspective and a portion only and reinvesting that to accelerate our commercial performance. The last thing I would say is this is only the first quarter, right? And we want to set the business up for success in the remainder of the year.

Yes. I'm sure we're going to get more questions on Cornerstone and Pi-Cardia. But just high level, I'd say, first on Pi-Cardia, excited about the investment. And it's part of a broader theme in Structural Heart, where we're just making -- doubling down on that space. We made the Anteris investment a few months ago in the TAVR space. We're investing heavily in tricuspid and mitral. We've got an ecosystem that we're building with [indiscernible] on the sizing as well and now Pi-Cardia here. It's just another investment in the space, and we're bullish on it, and we're going to keep going there.

And in terms of Cornerstone, look, we're just really excited about our progress in soft tissue. We've made a lot of progress. We talked about it in the commentary on Hugo. That's our play in the U.S. cornerstone is really about access and choice. It's a global play for us. It's one of a number of investments we're making in soft tissue, but this one in particular, it's a global play. It gives customers choice around the world, and we're really excited about it. And it just goes with a bunch of other investments we're making. Our Touch Surgery platform, our digital platform, we believe we're leading, and we've got a nice lead in Touch Surgery, and we were at 1,500 installed base. We just rolled out our newest version of that aid, which is like 300x more computing power in the surgical suite or investments in visualization, robotic instrumentation. So there's a lot going on in soft tissue, and we're really excited about our progress there.

Our next question comes from Larry Biegelsen at Wells Fargo.

I'll keep it at one, Geoff, and follow-up on Cornerstone, just maybe expand on the deal rationale. I'm going to just ask it head on. Some investors may think this is a signal that you're not confident in Hugo, address that and maybe a little bit more on the financial implications and which markets you're going to launch a and whether it includes the U.S. And just lastly, is there an option to acquire the company.

Well, look, we've got Mike Marinaro on the line here, too, from our medical surgical portfolio. I'm going to turn it to him for a second, and then maybe, Thierry, you can hit some of the financial questions. But on the Hugo question, just the opposite. I mean, we're very excited about the progress that we're making in Hugo. We talked about it in the commentary, we'll be by the end of the fiscal year, over 50,000 cases, 250 units installed we're continuing to roll out new -- we're getting new in clinical indications. We expect multiple new indications by -- in the fall here. We're investing.

I was just in our North Haven Connected facility, where we do a lot of the instrumentation last week, and we've got host of new instruments coming out. So we're really bullish about Hugo. That is our U.S. play and other countries as well. But Cornerstone, like I said, does give us it's like more of a global play. Gives our customers -- it helps us drive up access to robotic surgery, which is very underpenetrated, particularly in emerging markets, and it gives our customers choice. And maybe I'll call on Mike to provide a little bit more detail and answer some of the other questions and we'll go back to Thierry on the financial side.

Yes. Thanks, Geoff. And Larry, thanks for the question. I think Geoff covered it very well. This is a distribution and partnership deal that we're very excited about. As Geoff mentioned, this is a global play. It's an opportunity for us to build out a full portfolio of robotics, a full portfolio offering and an ecosystem. And it builds on the progress that we've made with Hugo. I think Jeff just spoke to it. But this quarter, we've spoken about now our expectations around installs. Really pleased to see with Hugo that our procedure volume, continues to grow at 2x the market rate and then our digital ecosystem, of course, is now expanding.

I think as you've seen at society of robotic surgery, I know you have a prominent presence there. There is a growing suite of capabilities globally. And it's becoming clear to us that there are going to be 2 or 3 platforms that we'll win in the market. And this is an opportunity for us to build out a portfolio of offerings that really meets the customer need and the specifics of the customer situation very well where they sit. So this is an opportunity for us to take that strategy and expand access in one of the largest markets in med tech that is still highly underpenetrated, and we see it as complementary and really just an expression of our confidence in the progress that we continue to make here with Hugo.

Lastly, I'd say we're in this to win. This is a critical area for us. We are leaders in surgery. And this investment is an investment to build out that portfolio of offerings because we're here to win, and we're excited about this platform and portfolio that will build together between Hugo, Cornerstone and our Touch Surgery ecosystem.

And then on the financials, hi, Larry, just -- so for this year, other than the impact of the foregone interest that I mentioned in the previous question, the impact should be minimal. Starting in '28, we should start seeing the impact of the distribution agreement. And this will contribute to the growth that we're experiencing coming from robotics, generally speaking, first with Hugo and now with Sentire, making that stronger and stronger. So we do expect to see a lift in volume and in margins coming into '28 through the distribution agreement.

The question on the acquisition. Look, we -- on the potential acquisition, we just made a large investment. The investment that we made just provide us some strategic optionality going forward, I would say. But the way we're approaching it is similar to what we do in a lot of these investments. We like to take a position, have a seat on the board, understand how the company is being run, start developing the collaboration. And then we understand what's under the hood, so to speak, consider our options. So some optionality there.

Just Larry, just to reemphasize, I just want to make sure we're not missing any words here, and there's no earnings peak. We are doubling down here. We have a lot of confidence and conviction about our position in soft tissue right now. And as Mike said, that's the key word in it. We're building a winning strategy here. We feel good about our position. I feel good about Hugo. We've got confidence and conviction, but there's no arrogance as my college hockey coach used to say, head on a love Panther like stance. lots going on here, and we've got to continue to invest and continue to execute here. We like our we want to become that meaningful #2 and gain on the market leader. And we really like the -- what we believe is a multiyear head start over the next scaled competitor, which is important.

Thanks, everyone. So Vijay Kumar, you are next. Vijay at Evercore.

Congrats on the nice spring this morning. I hired a 2-quarter for you, Geoff. One diabetes split off timing. When you look at Medtronic versus stock prices and MiniMed stock, obviously, it's come off the bottom. Why not? What is the hesitancy in announcing the split off in on CAS. I want to make sure I heard this correctly. I think your prior comment was about what is the rate of market growth. And I think today, you said $2.5 million ex the rate of market growth. So did underlying cash assumptions improve? And now what is driving this confidence?

Well, thanks, Vijay, for the question. Maybe I'll start with the cash question, and then Thierry can take the diabetes question. Yes, we did say for the balance of the fiscal year, that we would grow 2.5x the market. And we think the market's mid-teens in Q3 or Q2, rather, it might even be higher than that. So look, we're just -- there's a lot going on in CAS I'd say. First of all, there's still room to run on Sphere-9, right? We're still relatively early in that launch as evidenced by the 35% sequential growth over the prior quarter. It tells you we're still early. And Sphere-9 remains kind of one of a kind in that dual energy point-to-point space. And it's with a lot of different features and benefits that physicians like and it continues to grow, and we're getting more clinical indications there. We're on the -- we took out a CE Mark for VT, geographic expansion, we're just launching in Japan. So it's just a lot of room to run on that one.

And then we're starting to see progress with Sphere 360 in Europe. And we're going to keep going here. We're building out an ecosystem. That's a trend to here at Medtronic. You saw it in CST, this procedural or surgical ecosystem. We're doing that in soft tissue, and we're now doing it in various areas of cardiology, as being one, we talked about 2 investments in ICE technology last quarter, and we're going to keep going. So again, not too dissimilar from soft tissue. I mean, we like our position. And this one, we're further ahead and marching towards that market leadership. But you got to keep investing here, not just in the therapy itself but also the ecosystem around it. And I forgot about mapping too, the integrated mapping continued to kind of drive mapping upgrades every year. So there's a lot going on in CAS, and that's driving our -- plus you got a great market, right? The market is growing fast. So all that is giving us the confidence and conviction. And then I'll turn over you on Diabetes.

Yes. And just on CAS, it's -- you're right, Vijay. It's 2.5x the market on the full year. We expect it to be north of 3x the market in the second quarter. So we expect another good quarter in Q2 despite comps that are getting tougher and tougher. On diabetes, look, first, as you mentioned, it's great to see that the stock has come back up, and we're encouraged to see that. I think it's a testament to the fact that the business is performing, right? So they had a good fourth quarter last year.

As you can see in the print here and [ Chad and Kew ] will give you more details a bit later. They had a good first quarter. So growth is accelerating, in particular, in the U.S. They have a ton of favorability from an innovation perspective. Every single launch is happening ahead of schedule, which is great news. So it's super encouraging going forward. There's no hesitation on our side. So no change in schedule or anything like that. We had mentioned that we would do the separation when we think the economics are optimal for our shareholders and for our stakeholders generally speaking and we stick to that position. So no hesitation, no hesitation going forward with the separation just when the time is right.

All right. Great. Next question comes from Mike Kratky at Leerink.

Awesome. Can you hear me right?

Yes, yes.

Great. So congrats on the strong quarter. Thanks very much for taking on really encouraging to see the 35% sequential growth for your U.S. affair installed base after 40% last quarter. So can you provide any additional color on utilization trends in centers after they've added in a fair system? How quickly are you seeing your PSA market share shift in those centers? And where are you seeing your share kind of stabilize over time there?

Well, we're seeing -- let me see here, going on my notes here. Well, so first of all, 75% of our U.S. installed base are at high volume centers, right? So right now, we're still concentrated in these high-volume centers, which is not a bad thing, but it also tells us we got room to run in the lower volume centers across the U.S. 30% of our accounts are doing 70% of the ablation, right? These are high-volume centers. That's the 300-plus ablations a year. That's what we define as a high-volume center. And then many of these large accounts have only 1 or 2 systems and they're asking for more.

So we're seeing -- like once Affera goes in there, most of our experience, Mike, is in these high-volume accounts, right? And once our system gets in there, the utilization is high. We're seeing them add systems. And so we're -- that's all good sign. That utilization number is something we're watching every quarter. And like I said, so we're focused on those high-volume centers, and we've got a lot of room to run in centers outside of these high-volume centers. You have anything to add there?

No. I think I'm glad you picked up on the 35% because it's 35% in Q1 after 40% in Q4. So if you think of just the mathematical mechanical impact of what that means from a pull-through perspective, it's just super encouraging.

And for just a variety of reasons. I won't go through all the list of benefits. [indiscernible] is becoming the workhorse in these centers. and that bodes well. And then we've got Sphere 360 coming, which, as I mentioned earlier, goes right at the heart of the largest -- our largest PFA competitor. So feeling bullish on CAS right now.

Great. Next question comes from Anthony Petrone at Mizuho.

Thanks, and congratulations here on a solid quarter. I'll stick to one and maybe go back to Vijay, which is maybe capital allocation and diabetes. There will be a pretty significant hole in the portfolio. It's also growth accretive based on the quarterly numbers for this fiscal quarter, Diabetes going 15%, excluding the week, you're at roughly 7%. So maybe how the capital allocation will change post diabetes being completely separated will the cadence of tuck-in deals accelerate? Will you consider scale deals? Is a buyback in the cards here as well, considering that med tech valuations are off the bottom but are certainly not at multiyear highs. So just looking ahead to what the capital allocation program looks like post diabetes.

Well, thanks, Anthony, for the question. Thierry can comment on the financial impact here. But on the growth side, at the Medtronic level, it's about 20 basis points, right? It's not -- and with our growth accelerating, we're very comfortable. And as we project forward, we're comfortable with losing that 20 basis points. And from a profitability standpoint, from a gross margin standpoint, it's a big step up. Thierry can through that. Look, the diabetes business is, it is fundamentally different from the rest of Medtronic. That's why we made this decision. It's more consumer-based. There's a number of other reasons. But financially, also that industry is a lower margin business, right, on its best day, materially lower than the rest of Medtronic.

And so getting that capital allocation question, I wouldn't say anything has changed. We've already made that switch, and you're seeing it in our performance. We've made that switch to allocating our capital to the highest growth opportunities in the highest growth, but also where you have confidence that they're going to be big. So high growth, large patient pools. And the third thing is where we feel like we have a right to win. We've got strong commercial presence, a good reputation. We understand the clinical nature of it. We understand the technologies, et cetera. And that's where our capital allocation is focused. We're much more prioritized in these high-growth areas, much more of a top-down at our leadership team level, allocating that capital. And you're seeing the uptick in M&A already, okay? That's broad-based, organic and inorganic.

And on the M&A, you've seen over the last 18 months, we've been working on this for probably 3 years to get that pipeline of M&A going. And it's not the scale deals, it's the tuck-in deals. And it's not just it's venture, an uptick in venture investing an uptick in structured deals where you're making investment and then you have strategic optionality later and then just flat out acquisitions. You're seeing it across the board. Prioritize in those high-growth areas. And we announced 2 more investments today. So you're going to see that continue in those areas of cardiology, neuroscience and our medical surgical area.

I don't know what to add, Geoff, that was a pretty complete answer. Just a couple of numbers. I mean, Jeff said, it's about 20 basis points of growth. It is lower margin. So when we deconsolidate diabetes, our gross margin will go up about 50 basis points. Our operating margin will go up about 100 basis points. Typically, the R&D as a percentage of revenue is about double in diabetes, what the rest of the business is. So it does give us an opportunity to reallocate capital to the other segments of the company where we typically get better returns.

As Geoff said, it's -- this is not a -- going forward when we did consolidate. It's something that we've already started doing. So if you look at the last 12 months or so, we went from doing about $2.8 billion of R&D and $0.5 billion of acquisitions to almost $3 billion in R&D and $2 billion acquisitions or investments. So we more than doubled the investment in innovation and that's something that we intend to continue doing going forward. So that's the recipe. And again, diabetes, the separation gives us on flexibility to do more of that. From a buyback perspective, no specific plans in that area, but never close to if the conditions are right, doing it for tactical reasons.

And just to kind of further emphasize the point and get into our mindset, just go back and look at some of our actions, right? In terms of prioritizing these high-growth areas. We had to take CAS, right, which we just talked about, AFib ablation. We had an organic -- we have an organic program, Pulse Select and at the same time, we thought the space was so important, we decided to go out and invest $1 billion in an inorganic platform. So multiple shots on goal. And here we are today announcing these type of results, we picked up another 9 points of share in the highest growth one of the highest growth segments in med tech. I mean we want to put together these decisive winning strategies.

And then we talked about soft tissue surgery. Again, a lot of investments organically in Hugo and that ecosystem around it, like the digital platform with touch surgery. And then here we go today announcing an inorganic investment, again, doubling down on these high-growth spaces where we believe we have a right to win and putting together winning strategies.

Just one thing I want to add because it's important. You might have seen in the numbers this morning, our free cash flow performance for the first quarter was very strong. Cash conversion is improving. We were at 70% in the first quarter, which is good, but we think we have a strong path of getting to 80%. We've got a strong balance sheet. So independently of the diabetes deal, we've got a lot of firepower to go do this is investment. So we look forward to continuing to deploy capital.

Okay. Great. Matt O'Brien at Piper Sandler, you are up next. Go ahead, Matt.

Great. Can you hear me okay?

Yes.

Okay. So just real quick, I know we're running long. On renal denervation, I just want to be sure I'm clear on the message here. because obviously, cash is doing really well. So how are you thinking about the trajectory of that business now, the market opportunity? Any updates on what you're thinking in terms of the market? And then do you really need Transat deal to accelerate that franchise over the next several years? Is it a reimbursement thing? What's really the clear message on real derivation here as we get this update here in Q1. Thank you so much.

Well, thanks for the question, Matt, on Ardian I still -- we have confidence and conviction that this is going to be one of the biggest things in med tech, right? And there's 3 things driving. You touched on some of them. One is the improving clinical evidence, which I'll touch upon. The other is broader reimbursement coverage and the third is market development. In terms of the evidence, right, the real-world outcomes just keep getting better. I don't know what else to say that we had great 3-year data at CRT, where you saw like an 18 -- over 18-point reduction in the office. Over a 13-point reduction in the ambulatory setting. I mean these are materially higher, like 2x, 3x, 4x higher than the clinical trial. We put in the commentary today, spiral a firm was accepted as a late-breaker TCT, so more data coming out. It's I think that's full 6-month data coming out in a very visible conference.

So what you're seeing is the difference from the trial is material in terms of the improved results. And we're also seeing really strong durability of these results, especially versus like ultrasound. So this is driving -- the conversation is shifting, right? KOLs and hospitals are coming to us to really get some of these programs going as they see this continued improvement in clinical evidence also driving that would be more improvement in reimbursement coverage, right? Beyond the national coverage decision for CMS, we're seeing these commercial payers continue to jump on board. And this quarter, we had a number of them, particularly with some bigger ones like Highmark. So we're seeing that reimbursement coverage improve. And then the market development. That's where a lot of the focus is now. And look, as I know, Matt, you get out there, you talked to a lot of the KOLs and we're out there talking to them as well as the hospital C-suite. And the conversation, like I said, is shifting the enthusiasm there and we're really partnering with them to build out these programs on the back of the clinical evidence on the back of more insurance coverage, building out those referral pathways in driving consumer/patient awareness on these.

So again, we thought we made a good progress on a number of those leading indicators, and it bodes well for the ramp here over the next quarters and years to come.

All right. I think we have time for 2 more. So the next question comes from Robbie Marcus at JPMorgan.

Great. Congrats on the nice quarter. Thierry, I wanted to ask on margins. This quarter, it came in just a bit above the Street on operating margin. How are you thinking about reinvesting this top line upside versus driving margin expansion, both in the first quarter and for the rest of the year? And then a quick follow-up. You talked about tariffs rebates offsetting tariffs paid. Do you have the tariff rebate number, so we can all keep track of that as some of the onetime benefits in the quarter?

Yes. Thanks, Robbie. So I'll start with the rebates with the tariffs, sorry. So the refunds in the first quarter were such that we were a slight net negative on the impact from tariffs. So they almost compensated the full tariffs. Going forward for the year, just to be clear, we have not embedded future refunds. So we wanted to remain prudent going forward. So we're -- we have a construction for the remainder of the year that doesn't bank on any refunds happening. We are continuing to submit for refunds. So there's a potential upside coming from that. From a margin expansion perspective, look, we're in growth mode. So we're taking a portion of the upside that we're seeing from a revenue perspective and reinvesting in the growth areas and a portion only.

And so the construction that we've got on a full year basis today still calls for an operating margin that should be up about 50 basis points on a full year basis. which should put us with a net profit up 10%, so significantly higher than our revenue growth. So look, we're going through all the different parts of the company, right? Cost of goods sold, the manufacturing efficiency, the relationships with the suppliers. We're looking at logistics cost and we're looking at overhead. And we're really looking at how we can drive efficiency at every level and it's starting to pay off. You've seen some of it in the first quarter. And on the full year, we're going to deliver a leveraged P&L.

All right. I'm waiting for my queue up here on our last question which should come from Rick Wise at Stifel. All right. Thanks. Rick, please go ahead.

It might be on mute Rick? You want to go the next one?

Yes. All right. Rick, we'll get you on the next one, please. The next question is going to come from Joanne Wuensch, Citi.

Really nice quarter. To wrap it up, I think I'll ask about Charlotte, North Carolina. And why are we going there? And what can we expect from the analyst meeting and my second question sort of probably ties to that one. For a while, I use to think of Medtronic or we used to think of Medtronic as sort of a mid-single-digit revenue grower, high single-digit EPS. Has that formula shifted?

Well, look, I'll start with your last -- the back half of the question and let Thierry pile on there. But look, we're -- Thierry mentioned between the strong cash so that we're generating or our cash flows, improving here continues to improve. It's always been good, but it's improving. Had a really strong quarter. We're going to continue focus on that. And then our focus on gross margin and operating margins are going to allow us to invest more, both organically and inorganically. And in ramping up our inorganic tuck-in acquisitions combining that with our organic, you're seeing effectively a doubling of our investment in innovation, and we've been doing this for a while.

And now you're seeing that growth tick up. And clearly, we have aspirations for higher growth than we've done historically. You've seen over the last couple of years, we've gotten the growth to mid-single digits, but we're not satisfied with that. That's why the more investments and the focus on execution. We have -- I can't describe in words the sense of urgency on the investments and the execution to continue. You've seen in the last 2 quarters a bit of an inflection of growth and we want to kind of continue with that. So before I get to the Charlotte, Thierry, any other comments on that?

No, no, I think you said it all. So we're clearly at an inflection from a growth perspective. And we're working the P&L. As I just said, we're continuing to make progress in pricing. We're continuing to make progress in cost out. We're reinvesting in innovation, but we're getting leverage from an overhead perspective. So we're really focused on driving the leverage on the income statement as well. And it's one of the things that we'll talk about in Charlotte.

And so Charlotte, why are we going there? So look, the IRCAD facility there in Charlotte is an impressive facility. IRCAD, is mainly historically outside of the physician training outside of the U.S. This is their first North American site and we have a big presence in that site. And it's a good way, Joanne to actually see -- especially a lot of our technology now is -- or more and more of it is capital. So you got our able platform and Stealth AXiS. You have all of our soft tissue technology, which we keep adding to, you have the digital piece. It really helps to see it in action and IRCAD is set up so that you can actually see it.

We'll have physicians there, walking you through it and describing how they're using it. And these are physicians that also use our competition. We all have our weak moments but they'll be able to provide, I think, a good balance of how we stand versus the competition, and we'll talk about where we're going with these technologies as well. And then the other thing, look, on these earnings calls, and some of our other events that we do, the different banking meetings, we don't get a chance to go in depth with some of the other parts of our growth pipeline. And so there's a lot that we haven't talked about that we're going to talk about. And in addition to that, you're going to go down a layer into the org below my leadership team to some of the business unit leaders and experts in these specific areas, and you're going to hear it from them as well.

So physicians plus the business unit leaders themselves, new growth new growth investments that we haven't talked about and then going way deeper into some of these big areas like these surgical ecosystems. And in a showcase, a space that is built for this. And so December 10 and 11, please mark your calendar. It's -- we're really excited to share, and I know the team is as well. So thanks for the question, Joanne.

All right. Great. Well, that wraps up the call. So thank you, everyone, very much for joining. I appreciate your support and continued interest in Medtronic. And Geoff, if you have any other additional prepared remarks, please go ahead.

I mean, look, thanks for -- thanks, as always, thanks for joining today. Really appreciate the engagement. I appreciate the support and the continued interest in Medtronic. With that, have a great rest of your day, and thank you very much.

Good morning, and welcome to our fiscal '26 fourth quarter earnings webcast. I'm Ingrid Goldberg, Head of Medtronic Investor Relations. I'm joined by Geoff Martha, Chairman and Chief Executive Officer; and Thierry Pieton, Chief Financial Officer. Geoff and Thierry will provide comments on the results of our fourth quarter, which ended on April 24, 2026, and our outlook for fiscal year '27. After our prepared remarks, we'll take questions from the sell-side analysts that cover the company.

Earlier this morning, we issued a press release discussing our quarterly results and several financial schedules. We also posted an earnings presentation that provides additional details on our performance. The presentation can be accessed in our earnings press release or on our website at investorrelations.medtronic.com.

During today's program, many of our statements will be forward looking, and actual results could differ materially as explained in our SEC filings. We undertake no obligation to update any forward-looking statements. Unless otherwise stated, all comparisons are on a year-over-year basis and revenue comparisons are made on an organic basis, which excludes the impact of foreign exchange, prior year revenue from the divestiture of the Dutch Obesity Clinic also known as NOK and fourth quarter revenue in the current and prior year reported as Other.

References to sequential revenue changes compared to the third quarter fiscal '26 and are made on an as-reported basis. All share references on its revenue and year-over-year basis and compare our fourth fiscal quarter to our competitors' first calendar quarter. Reconciliations of all non-GAAP financial measures can be found in our earnings press release or on our website at investorrelations.medtronic.com. And finally, our EPS guidance does not include any charges or gains that will be reported as non-GAAP adjustments to earnings during the fiscal year.

With that, I'm now pleased to hand it over to Geoff.

Okay. Thanks, Ingrid, and good morning, everyone, and thank you for joining us. In our fourth quarter of fiscal 2026, we delivered $9.8 billion in revenue, up 9.9% on a reported basis and 6.6% organically. So for the full fiscal year, we delivered $36.4 billion in revenue, up 8.4% reported and up 5.8% organically, marking our strongest top line performance in 10 years.

And on the bottom line, we delivered Q4 and FY '26 adjusted EPS of $1.55 and $5.53, respectively, ahead of expectations and reflective of our commitment to operational rigor as we invest in durable growth.

These results represent the compounding impact of deliberate choices we've made across strategy, operations and culture. We saw continued strong execution across our largest foundational businesses like CRM, CST and Surgical. And we made material progress on our highest growth platforms. We much toward leadership in CAS, advanced simplicity and Hugo and build momentum in Altaviva and Stealth AXiS, all while supporting our uniquely deep pipeline of innovation.

In Q4, we advanced our commitment to further focus the company, deploying capital in line with our capital allocation priorities and meaningfully increasing our investments in M&A, ventures and partnerships. And I am incredibly proud of our teams. Through a dynamic macro environment, we have executed and we've executed with discipline to deliver an excellent fiscal '26 that will continue into fiscal '27.

And now let's turn to the details of our fiscal fourth quarter, beginning with Cardiac Ablation Solutions. Look, CAS delivered another outstanding quarter with 78% worldwide growth and gaining an additional 8 points of U.S. share. PFA saw exceptional global growth of 145% with Sphere-9 continuing to demonstrate broad versatility.

And we are still in the early innings for Affera. In the U.S., we increased our installed base by 40% sequentially, and we see significant runway for continued expansion. Globally, we're now rolling out PRISM 2, our next-generation mapping software. PRISM 2 unlocks meaningful benefits, including improved navigation, using hybrid impedance and magnetic mapping to better visualize nonsensor based catheters.

As we look ahead, we're expanding our entire EP ecosystem, expanding geographically into new indications and with an exciting cadence of new innovation. In Q4, we launched Sphere-9 in Japan, where we expect to extend our market leadership. We also secured FDA approval for our U.S. VT pivotal trial, which we aim to begin enrolling in the first half of FY '27. This is an important population due to the complexity of these potentially life-threatening arhythmias that are often really difficult to treat.

Now further strengthening our EP offering is our Sphere-360 catheter the only rotation free, large tip, single-shot catheter that's available. Sphere-360 is CE-marked and launching in Europe. Early physician feedback is really strong, and our U.S. pivotal trial is enrolling swiftly. And as you saw in our additional press release this morning, we are continuing to invest in a fully integrated EP ecosystem with 2 targeted investments in ice catheter technology that will give physicians real-time digitalization of the heart. This will further enhance the Affera platform over time to extend our capabilities.

Now through innovation, purposeful investment and global execution, we plan to completely surround the electrophysiology space and offer patients and physicians a more complete end-to-end set of EP solutions.

Next, I'd like to share our progress with Symplicity Spyral, which is a novel onetime minimally invasive approach to treat hypertension. Hypertension represents a massive unmet need. Now despite the use of multiple medications, roughly 18 million people still live with the uncontrolled hypertension in the U.S. alone. Our Symplicity physician finder now spans 200 doctors across more than 300 accounts, connecting patients with physicians as demand grows. We've also seen a significant uptick in prior authorization approvals. And since the NCD, we have doubled average weekly procedure volumes. And now Symplicity Spyral is annualizing at $100 million.

At CRT this year, we presented late-breaking long-term data reinforcing the clinical outcomes of RF renal denervation. In over 2,000 patients, Symplicity delivered sustained, mean systolic blood pressure reductions of 13.3 and 18.1 milligrams of mercury and ambulatory and in office settings at 3 years, respectively, with 90% of patients achieving a meaningful benefit. And as a reminder, a 10-point reduction in BP is proven to show a greater than 20% reduction in major cardiovascular events like heart attack, stroke and heart failure. So this is critical and underscores the impact of Symplicity on patients and the health care system itself.

Importantly, we stand apart as the proven platform in a category with enormous unmet need, and we intend to lead it. We are confident in the foundation we've established with robust and growing clinical evidence, a broad label, expanding reimbursement and growing demand from both physicians and patients. We are well positioned and in the early stages of this ramp to redefine the standard of care in historically drug-based setting with a new option for managing hypertension.

Now we're also starting to see meaningful impact from Hugo, our surgical robotic system. Our worldwide procedure volume growth is 2 to 3x the market and utilization is increasing. Last quarter, we launched Hugo for Urology in the United States, placing systems at leading institutions and treating our first patients. Feedback from surgical teams has been positive, both in terms of their experience, and early clinical outcomes.

We are pleased to announce that in late April, we submitted to the FDA for 510(k) clearance for general surgery and gynecologic indications, as well as for our LigaSure RAS vessel sealer. We also recently received FDA clearance for our Pro Grip Advanced, a new mesh optimized for robotic-assisted ventral hernia repair procedures. And our Touch Surgery Digital Ecosystem, well, it continues to represent a clear advantage with over 1,400 installations, up 30% plus sequentially.

We are complementing our strong foundation with data and analytics driving a more precise, intelligent and a predictable future in surgery. Digital is creating real value in the OR, and we are investing and innovating to lead in this space. We are building our robotics program deliberately. We are driving utilization and procedure growth globally, making steady progress in the United States and investing to strengthen our broader surgical franchise over time. Hugo is having an impact on our MedSurg portfolio, and we are pleased with the early progress.

Now moving to Altaviva. Momentum here continues to build. And we are encouraged by the strong physician feedback and early patient demand. Altaviva redefines what is possible for patients with urge urinary incontinence with same-day activation, up to 15 years longevity and full body MRI access, while the device remains on patients start therapy sooner and live life with fewer disruptions. We've trained nearly 1,000 physicians since launch, and that investment is starting to translate into commercial momentum.

Sequentially, active implanters are up 3x. And patients treated are up 2.5x. Importantly, as physicians gain more experience and move through prior authorization more swiftly, implants are accelerating.

Finally, we executed our focused portfolio strategy. In early March, we completed the MiniMed IPO, establishing it as a stand-alone publicly traded company. We also advanced our M&A and venture initiatives, targeting higher growth segments to accelerate innovation in markets where we have a right to win.

In our coronary portfolio, we closed on the Cath works transaction. Cath works FFRangio system uses a combination of AI and advanced computational science to improve decision-making in the cath lab. The company recently presented positive 1-year data from the all RISE trial, validating FFRangio as a noninvasive technology poised to disrupt the gold standard traditional wire-based FFR, which is a $1 billion segment growing in the low double digits.

We announced plans to acquire Scientia, an SPR Therapeutics as well as investments in Beluga Medical and CardioACC. Scientia will meaningfully expand our neurovascular platform with differentiated guidewire technologies for stroke, enabling every neurovascular procedure to start with Medtronic. SPR Therapeutics for P&S will build out our portfolio of chronic pain management therapies. And Beluga Medical and CardioACC will advance development of next-generation ICE catheters that will further advance our EP toolkit.

In our venture portfolio, we invested in emerging technologies, including Pulnovo, a first of its kind minimally invasive system designed to address pulmonary artery renovation. And we entered into a distribution agreement with Merit Medical for ViaVerte which brings an FDA-cleared solution for chronic tibolgenic back pain. Now both of these transactions will expand our reach into new and high-growth adjacencies where we hold leadership positions.

These investments are deliberate and tightly aligned to our strategy of reinforcing leadership positions, building scalable ecosystems and extending our reach in attractive markets. Together, these meaningful tuck-in investments position us to drive sustainable growth for the near and the long term.

Now these are just a few highlights from the quarter. Looking across the business, multiple operating units contributed to the strength in Q4, like CST with Stealth AXiS or CRM with OmniaSecure and Micro and many others, which Thierry will cover in more depth.

So to close, I want to start with thanking our teams not only for delivering a strong year but embracing the changes that have enabled this performance. In a world with many moving pieces, we are executing. We are delivering. We are delivering on our strategic priorities and accelerating access to life-changing therapies, all while creating meaningful value for patients, for physicians, for health care systems and for our shareholders.

Now with that, I'm going to turn it over to Thierry. He's going to walk through the financial results of both the quarter and the full year before turning to guidance. Thierry?

Thanks, Geoff, and hello, everyone. I appreciate you joining today. Let's start with cardiovascular, which delivered 10% revenue growth this quarter, led by 14% in the U.S. and 7% in international markets. Driving this performance was 78% growth in CAS, including 124% in the U.S. In a $14 billion market that grew about 20% in Q4, we're now annualizing over $2 billion in revenue and are on track to reach $2 billion trailing in the first quarter of fiscal year '27.

Cardiac Rhythm Management delivered 5% growth in both U.S. and international markets. Defibrillation delivered mid-single-digit growth, including high teens in ICD and mid-60s in EV ICD. We saw strong momentum in the recently launched OmniaSecure defibrillation lead following our indication expansion that allows for conduction system pacing.

Cardiac pacing therapies delivered mid-single-digit growth, driven by mid-teens in micro and high teens in the [ Select Secure 3830 ] lead for CSP.

Turning to Structural Heart. Performance in the quarter was flat. We saw strong international performance, while the U.S. was softer in part due to the lowest data. We're encouraged, though, by the trajectory we've seen in the field as weekly U.S. procedure volumes have stabilized over the last 8 weeks. Structural Heart clearly remains a strategic priority for us, with internal programs in mitral and tricuspid replacement and targeted external investment in TAVR, including paving the way forward.

Coronary declined in the quarter but was offset by strength in renal renovation as described by Geoff. Importantly, we saw a clear acceleration of simplicity in the back half of the year. We're pleased to see the sequential lift and feel well positioned to drive momentum going forward. Finally, Peripheral Vascular Health delivered low single-digit growth and cardiac surgery was up mid-single digit.

Moving to neuroscience. Our position in neuroscience is strong. We have the most comprehensive portfolio and are the #1 player and category leader across each of our segments. We're investing across the portfolio to advance pipeline innovation and accelerate long-term growth. This quarter, we delivered 3% revenue growth globally, driven by 6% in international markets.

Cranial and Spinal Technologies was up 3% in both U.S. and international markets. Core Spine gained share this quarter, growing 6% on continued module X expansion and distributor conversions. In Neurosurgery, results improved sequentially, supported by low double-digit growth in navigation following the launch of Stealth AXiS late in the quarter. Stealth AXiS platform is an important growth driver for our CST business. The early commercial launch is progressing well. Physician feedback has been very positive and sales are off to a very strong start.

This quarter, we achieved FDA clearance across spine, cranial and ENT indications as well as CE Mark for spine and cranial broadening the platform's reach across our portfolio. [ Luxtelth ] is a force multiplier, driving across planning, robotics and our broader able ecosystem. It promotes the adoption of robotics in spine surgery, creates efficiencies that allow more physicians to integrate it without disrupting workflow. All of this makes our installed base stickier over time.

With robotics penetration still in the high single digits, we see significant runway ahead. Specialty Therapies delivered 3% growth. Neurovascular was up 6% driven by 11% growth in hemorrhagic, including healthy adoption in Euro garden RTs. We are actively investing in Neovascular as evidenced also by our planned Scientia acquisition. Scientia represents a significant advancement in navigation, enabling euro interventionalists to reach areas of the brain that were historically extremely difficult to get to.

ENT delivered another quarter of mid-single-digit growth, including high single-digit in international markets. In Pelvic Health, results were flat as solid growth in Altaviva was offset by broader market softness in sacral nerve modulation. Given the progress our teams have made, we look forward to seeing Altaviva continue to scale into 2027.

Finally, neuromodulation was up low single digit. This is another area of strategic focus and investment as demonstrated by our expansion in BVNA and planned acquisition of SPI Therapeutics, an attractive space growing over 20% annually.

Now turning to Medical Surgical, which delivered 5% growth globally, including 8% in the U.S. Surgical revenue increased 3% globally split evenly between the U.S. and international markets. Performance was driven by high single-digit growth in both Advanced Energy and Wound Management as well as an increased contribution from Hugo. This was partially offset like in prior quarters by continued pressure in bariatrics.

Endoscopy delivered high single-digit growth, driven by strong adoption of Endoflip in the U.S. and Western Europe and market share gain in Nexpowder in the U.S. And then acute care and monitoring was up including high teens growth in the U.S. Results were driven by mid-teens growth in Nalcor post oximetry, high single-digit growth in respiratory and airways as well as mid-single digit in perioperative. The outsized strength we've seen in ACM was a positive tailwind to the quarter. Looking ahead, we anticipate this growth to normalize as we head into fiscal year '27. Overall, we are very pleased with the finish Medical Surgical had to close the year.

Rounding out with the diabetes business, we completed the MiniMed IPO during the quarter, marking an important milestone in establishing MiniMed as a stand-alone publicly traded company. For the quarter, the Diabetes business delivered 15% reported growth or 8.1% organic, driven by strong international execution and continued momentum in U.S. CGM and new patient starts as the team prepares for the commercial launch of MiniMed Flex during the summer. Look, we're excited to see the MiniMed team share more detail on their first earnings call later this morning.

Before we move into the details of Q4 and guidance, I'd like to remind everyone that the diabetes financials as reported by Medtronic are prepared on a different basis than the stand-alone MiniMed ones. Accordingly, you cannot precisely estimate Medtronic remainco financials by subtracting one set of financials from another. As with prior similar transactions post split, when Medtronic is no longer the majority shareholder of MiniMed, we will provide Medtronic guidance that will reflect updated operational performance metrics and share count.

Now turning to financials. Revenue this quarter of $9.8 billion grew 9.9% reported or 6.6% organic. This represented a 60 basis points acceleration from last quarter on a far more challenging comp. This caps the strongest annual performance we have seen in 10 years. Geographically, performance was balanced with 7% growth in the U.S. and 6.2% internationally.

Before I turn to the P&L, I want to pause and take a moment to acknowledge our Medtronic colleagues, especially those in the Middle East and impacted countries who despite the ongoing conflict have remained focused on serving our customers and our patients. Their performance under tremendously difficult circumstances reflects their commitment, resilience and the strength of our mission and culture, so thank you.

On that note, I will now turn to walking us through the fourth quarter P&L. Our adjusted gross margin was 65.4%, up 30 basis points year-over-year and up 50 basis points sequentially.

Let me walk you through the elements shaping gross margin this quarter, as I usually do. Similar to Q3, our disciplined pricing provided 30 basis points benefit. Net of inflation, cost down contributed 60 basis points, driven by COGS efficiency programs as our portfolios, global operations and supply chain teams delivered material savings, improved efficiencies and higher yields. Mix was unfavorable by 60 basis points, largely reflecting the diabetes business as well as higher mix of lower-margin capital to higher-margin catheters in our CAS business. While a near-term headwind to gross margin rate, this represents a favorable leading indicator as it reflects further penetration of the market and strong pull-through potential for future catheter sales.

Tariffs impacted the business by $74 million or 80 basis points, in line with expectations. And finally, foreign exchange was an approximate 80 basis points tailwind.

Moving to overhead. Adjusted R&D was roughly 7% of revenue in the fourth quarter and fiscal year R&D grew $150 million as we march towards higher investment goals. Q4 today we closed or announced nearly $2 billion of additional investments as we executed on M&A and venture capital strategy. We expect recent M&A to contribute approximately $150 million to inorganic revenue growth in fiscal year '27 and to be a healthy contributor to our organic base in the out years.

Within our venture portfolio, we also made 16 venture investment this fiscal year, totaling approximately $250 million. Each of these investments are in growth accretive adjacencies and should generate strong returns and potential acquisition opportunities in the years ahead. We're committed to accelerating our pace of innovation and top line growth through a prudent and strategic combination of organic and inorganic investment.

Adjusted SG&A was 30.5% of revenue in the quarter, up 30 basis points year-over-year. With favorability below the line, this quarter, we made a deliberate decision to accelerate investment in our commercial firepower to support our key growth areas. Our adjusted operating profit was $2.5 billion, resulting in an adjusted operating margin of 25.5%. This included impact of 160 basis points from the MiniMed Blackstone payment and 80 basis points from tariffs. Our adjusted tax rate was 17.7%, slightly better than expected. All in all, adjusted EPS was $1.55, above the midpoint of our guidance range and above the street expectations.

Free cash flow was $5.4 billion in fiscal year '26, the strongest it has been since 2022 and ahead of our expectations. We've made solid progress in working capital over the year. The team delivered notable progress in accounts receivable and controlled the inventory effectively. Our CapEx spend was up roughly $50 million and grew at a significantly lower rate than revenue. Because of this, we ended the year with a $9.2 billion in cash and investments, positioning the company very favorably to execute on M&A opportunities.

Look, our performance this year underscores the strength of our portfolio and the consistency of our execution. While we faced headwinds like tariffs and the transitional product mix, we made meaningful progress in our efficiency initiatives, driving COGS improvements and achieving gross profit leverage ex tariffs. Importantly, we remain disciplined in balancing performance with investment. We purposefully increased investment in SG&A, R&D and M&A to support innovation and commercialization in some of the most attractive and durable growth markets in med tech. I'd like to thank our teams for all the progress made this year, and I look forward to seeing this momentum carrying into the next fiscal year.

Speaking of '27, now turning to the guidance. I want to note that our full year guidance continues to include the diabetes business as Medtronic remains the majority shareholder of MiniMed through this spill-off process. Today, we're guiding fiscal year '27 organic revenue growth of 6.75% to 7.25%, including approximately 11.5% to 12% organic growth in the first quarter. This guidance includes a roughly 25 basis points tailwind from the diabetes business. It also incorporates the benefit from the additional selling week which is recognized in the first fiscal quarter. We expect it to contribute approximately 125 basis points to the full year growth and 500 to 600 basis points in the first quarter.

Additionally, based on recent FX rates, we expect the foreign exchange to be neutral to roughly $100 million headwind for the full year. with an approximate neutral to $50 million tailwind to the first quarter.

Moving down the P&L. We expect our fiscal 2017 margin to be roughly in line with the previous year, excluding tariffs. Pricing and COGS efficiency programs are expected to offset the impact of business mix primarily from diabetes. This pressure point will disappear upon separation. We anticipate a tariff impact to COGS of approximately $250 million in total, including $75 million in the first quarter. Including tariffs, we expect fiscal year '27 gross margin to decrease by roughly 20 basis points.

We continue to invest in innovation to accelerate the launch of key products. This includes incremental spend as we integrate several acquisitions. Overall, we expect our fiscal '27 operating margin to be up 60 basis points, driven by the absence of Blackstone milestone payments we saw this year and operating leverage.

Below the operating profit line, we're expecting an approximate 200 basis points headwind, driven by an increase in net interest expense as well as a slightly higher tax rate. We're guiding '27 EPS of $5.90 to $6. Fiscal year '27 incorporates several dynamic components, and I would like to be explicit around our assumptions on the inputs.

We have included an approximate 150 basis points benefit from the extra selling week to the full year. Because we do not yet know the timing of the MiniMed separation, we're taking a conservative approach and including the full year of the diabetes business and our estimates, including the associated monthly dilution and assuming no separation share count benefit in fiscal '27. Should we separate prior to year-end as per our intent, we could see potential upside from our current guidance.

We're factoring 2% dilution from M&A, which is roughly 1 point higher than what we shared last quarter as the timing of several of our deals actually occurred earlier than anticipated. We're taking the full tariff impact of $250 million, as mentioned previously, an increase of $65 million versus prior year. We have not taken into consideration any government refund. We've embedded also a roughly 1 point headwind from increased fuel and transportation costs due to the conflict in the Middle East. And finally, based on recent FX rate, we expect foreign exchange to have a neutral to 1% accretive impact for the full year.

For the first quarter, we would expect EPS in the range of $1.38 to $1.40, including a 600 to 700 basis points benefit from the extra selling week as well as roughly neutral impact from foreign exchange at recent rates. Look, all of this taken together, our approach to guidance for the full fiscal year positions us well for a strong performance in 2027.

And with that, back to you, Geoff.

Okay. Thanks, Thierry. Now as we come to a close, I'd like to take a step back. The macro backdrop, as you know, has been challenging and dynamic. But MedTech is structurally resilient because the fundamentals are durable, people are living longer, chronic disease is rising, and the demand for medical procedures will only grow. AI, digital, robotics as well as advanced electronics are meaningful accelerants. And at Medtronic, we are uniquely positioned to integrate these technologies for safer care, improved outcomes and stronger health care economics that scale globally.

I also want to take a moment to recognize Brett Wall, who will be leaving Medtronic this summer following an extraordinary 25-year career. Brett has been an integral part of our leadership team and played a defining role in shaping our neuroscience portfolio, including helping establish interventional stroke as a global standard of care and advancing innovation across neuromodulation. His impact on patients, on our strategy and our culture, it's been significant, and we are deeply grateful for his contributions.

As part of this planned transition, Dr. Kweli Thompson will step into the role of Executive Vice President and President of our neuroscience portfolio. Kweli is a proven leader with a strong track record of execution, deep clinical and operational experience, most recently leading our CRM business. He is well positioned to lead neuroscience into its next phase of growth. Again, we want to thank Brett for his leadership, and we look forward to Kweli's continued impact.

So we delivered a strong finish to the year, powered by the breadth of our portfolio and disciplined execution across the business. And look, we are not letting up. We are investing in the future. We are building momentum in our key growth areas, advancing innovations across the portfolio and deploying capital through targeted M&A, ventures and partnerships. Together with strong commercial execution and market development, these actions give us confidence in our ability to deliver durable innovation-led growth for FY '27 and years to come.

With that, let's turn to Q&A. Ingrid, can you please provide the instructions and queue up the analysts.

[Operator Instructions] We'll take our first question from Vijay Kumar at Evercore.

Geoff, congrats on a nice print share. Maybe Geoff, I'll start with the guidance question fiscal '27, excluding the extra week, I think, underlying 5.5 to 6, that's an acceleration in line with the prior assumptions. I think as CAS slows down, that's been a concern for the market, right? Can you just talk about what are the offsets which segments accelerated to offset of CAS and drives the confidence in this 5.5 to 6 organic?

Well, thanks for the question, Vijay. Maybe I'll -- let me just start with the cash comment you made, and then I'm going to turn it over to Thierry to answer the ins and outs and puts and takes of the guidance question. But on CAS, look, the impact of CAS to our growth will be very similar next year to this year. I mean we see the market in FY '27 in growing -- well, first of all, in Q4, we think the CAS market grew around 20%. In FY '27, we're thinking mid- to high-teens market growth and we're going to grow north of 2x that of the market rate. And again, the business has gotten a lot bigger, so its contributions to our growth or even more because of the size. And yes, so we're annualizing -- that business is annualizing now $2 billion. We're going to hit that $2 billion backward-looking revenue mark that I laid out there. We're going to hit that in Q1. That implies -- we're about 15% share right now and marching towards market leadership in CAS. So I don't -- we're not -- look, we're not talking about CAS slowing down its impact on our growth. I just laid out what I think it will grow, but the impact is strong. So I just want to clarify that first. And then maybe, Thierry, you talk about the guidance.

Sure. Vijay, so look, just maybe to give you the couple of components of the growth rate here. So the cardiovascular business should have a performance next year that's pretty much in line with what we've seen in '26. So it's in a -- it's got really, really strong momentum. Geoff just talked about CAS where clearly still in the early innings of the CAS development here. You probably saw in the commentary that from an installed base perspective, the installed base was up 40% in the fourth quarter alone. So that gives us a ton of headroom to grow the catheter sales going forward.

CRM will continue to be strong mid-single digit. We have a lot of strength coming from innovation, from Micra, from Omnia, from EV ICD, and that's going to carry into '27. And then staying in the cardiovascular portfolio, we expect to continue to see some strong lift coming from Ardian. So Ardian is now annualizing about $100 million revenue a year, and we expect that to continue to grow significantly into '27 and beyond.

And then we've incorporated a prudent guidance for structural heart. As we mentioned in the commentary, the business has been pretty stable over the last weeks, and that's what we've incorporated in the guidance going forward. So strong continuation in cardiovascular.

Then we've got the neuroscience portfolio. Hey, look, in neuroscience, we're leading in every segment we're in, and we're gaining share. And on top of that, we've got meaningful innovation in almost every segment out there. If you take CST, we have Stealth AXiS. Stealth AXiS is off to a really good start. About 50% of the revenue we get in CST is coming from consumables. And the more we sell Stealth AXiS, the more we're going to have pull-through on the consumables side and we're super excited about that.

In the Neurovascular business, you saw that we made progress this quarter that's going to continue into '27. We've got a ton of innovation coming there with Neuroguard product and with MMA, and that's going to continue going forward. And on top of that, we'll have the inorganic impact coming from the acquisitions. But expect neuroscience overall to continue to grow.

To accelerate.

To accelerate, yes. Continuing in neuroscience, in pelvic Health. Look, Altaviva is off to a good start, and it's going to continue to grow into next year. So you can see every single franchise in neurosciences is going to accelerate going forward.

And then if you look at MedSurg, Look, MedSurg had a great quarter in Q4 with Surgical being pretty strong, around 3%, both U.S. and OUS. We had great performance from ACM and from Endo. Look, I think that business has great momentum. But we expect that growth to normalize a little bit or we haven't reflected, I would say, the run rate that we see in Q4 fully in the guidance that we taken into consideration for '27.

And then to finish with MiniMed, the team will comment more in detail on the following call after this. But MiniMed had a strong Q4. We expect our continued strength into '27. And MiniMed should bring about sort of 20 to 25 basis points of growth in the construction next year.

So look, all in all, if you look at what happened in '26, we started the year with a 5% guidance. Gradually, we increased it to 5.5%. We ended the year at 5.8%. The midpoint of our guidance this year is -- for '27 is right at that level, 5.8%. So I think we're positioning the business for success going into this year.

And our next call comes from Larry Biegelsen at Wells Fargo.

Geoff, congrats on a strong finish here. Geoff, I'm going to ask the one question. I think that one area of people are concerned about, which is your TAVR business. The Evolut 6- and 7-year data did get a lot of attention this year. What do you see or earlier this year, sorry, what did you see from a share standpoint in your TAVR business in fiscal Q4? Was there any difference in U.S. versus international? And what are you assuming for your TAVR business in fiscal '27?

No, thanks for the question, Larry. I'd say -- I know there's been a lot of talk on TAVR and Evolut. I'll say this, just to repeat what Thierry said to go, the business has stabilized, right? Over the last 8 to 10 weeks, it's been stable. We did experience a slowdown in growth, and it really was tied, we believe, to the low-risk data that came out. It's more of a U.S. dynamic, I would say. I mean, again, I just want to emphasize it's kind of -- it's an older technology. It's an old procedure, the procedure tactics we've changed. And it's limited to a large size valve, which is more used in the United States. So it's not really impacting us outside the U.S. like it is in it's stabilized, and we're moving forward now, right? So we're heavily investing into this business. We announced a big investment last quarter. We're investing in this software, where we've got mitral and tricuspid. And so we're feeling good going forward. We've got some new fresh leadership there that's running fast. And -- so I don't know if you have anything to add to that, Thierry, in terms of next year?

I would just say, look, in Q4, we grew 6.6% despite the headwind that we had from TAVR, in particular in the U.S., as you said, Geoff. And what we've seen over the last 8 weeks is a stabilization of that business, and that's what we've modeled going forward.

Our next question comes from Travis Steed at Bank of America.

I'll start with MedSurge grew 5% this quarter, surgery grew 3% this quarter. Maybe just how you factor these businesses and as you talked about accelerating growth next year into the guidance and to keep these businesses at kind of these higher growth levels? And on Hugo, when does that start to show up on the surgery growth? And when do you expect Hugo to start contributing positively to the margin and EPS profile versus being an R&D investment and how to think about the return on that program?

Well, look, I'd say, first of all, on MedSurg, it was a great quarter, and it was pretty much across the board, right? The surgical business accelerated to 3%. As Thierry just pointed out, you have ACM at nearly 11%. Our endo business at 9%. I mean, Mike, Mariner and the team have done a great job building to this. And like I said, it was a great quarter. And in there, Hugo contributed, right? We had told you that we thought Hugo would have an impact towards the end of FY '26 and it did in Q4. It's -- we're feeling really good about the feedback we're getting on the launch. We announced this morning the submission to the new indications, General Surgery, and LigaSure RAS, so we've got those submitted. And the feedback we're getting on the early cases is good.

We're seeing the smooth case rate is up. That means how many cases, everything goes well in a case that's really important, especially in the U.S. where the physicians really test the system. Our procedures are meaningfully up and utilization continues to be strong. We've got additional placements, installations in the U.S. out outside of the U.S. And complementary to this is our Touch Surgery platform is -- installs are up 30% sequentially. We're now in over 1,400 ORs globally. This is going to be a real differentiator. I want to get to the point where we're talking about the enabling technology, not just Hugo, but all the enabling technology, including the digital piece, kind of like we do with in spine with Able, that's what we're building to. Obviously, Hugo is a big piece of that. So we're feeling very positive right now. You have anything to add to that?

I think you said it all.

Our next question comes from Ryan Zimmerman of BTIG.

Can you hear me okay?

Yes, we can hear you right.

Wonderful. So a lot of directions to go here, but I'm actually going to ask a little bit of a margin question to Thierry. Assuming you lap some of these tariff dynamics kind of midway through fiscal year '27, potentially MiniMed is coming off, and again, I appreciate that you're including it for the full year, but it would seem that there is opportunity potentially for a gross margin step-up particularly in the second half of 2027. And so is there anything else that we should be considering in terms of constraining gross margins as we think about it in the context of the 2027 guide?

No. So look, I think you -- the dynamics in the gross margin are pretty similar to what we've seen so far. So kind of peeling through the different parts, we'll have negative impact from the carryover of the tariffs issue or the tariff topic, I should say, in the first half to the tune of -- someone else that's on the line, sorry. So yes, so we'll have about $65 million of carryover coming from tariffs in the first quarter and the second quarter.

To your point, we'll lap that in the second half. And then if you look at excluding tariffs operationally, we expect to continue to see pricing lift as we did in '26. We expect to continue to see good traction from our cost of good sold, net cost out perspective. The team is gradually netting out better and better performance of cost out net of inflation, and we expect that to continue.

Then we've got the mix topic. And as you know, there are 2 drivers behind that. One is diabetes. To your point, if we are to separate diabetes before the end of the year, which is our intent, then we should see some lift in the gross margin rate coming from that.

And then the other dimension of the mix impact is coming from CAS, it's actually getting better because the margin of CAS is improving. And so we should see that being sort of a headwind going into the second half. So look, all in all, what we've embedded in the guidance here is a gross margin that's basically flat, slightly up, excluding tariffs. So I would say, very slightly up, excluding tariffs with a better performance in the second half than in the first half.

And then the good news is our growth is accelerating and growth we're getting operating margin leverage with better absorption of the overhead. And this will come primarily from the SG&A line going into this year. So yes, we'll have accretion in operating margin, in particular, in the second half of the year.

Our next question comes from Josh Jennings at TD Cowen.

I was hoping to just get a beat on the China franchise, not the [ sexiest ] question here, but historically, China has been a growth channel. There have been some headwinds with VBP for a couple of business years. But what's the outlook for for 2020. Maybe help us think about exposure there as a percentage of revenue? And is that -- is the China franchise going to be accretive or dilutive to the organic revenue growth guidance?

Look, thanks for the question, Josh. I haven't got a China question in a while. Look, China is -- we still view China as a growth market. So when we think about China, we think about it as a growth -- as an end market. We don't have a whole lot of exposure in terms of manufacturing in China for export outside of China. So we don't really have much exposure there. That's very small. It's really about how it continues to be a profitable growth market for the company.

And look, we've had to navigate a number of these VBP and I think VBP is here to stay, but we have the worst is behind us. And we've -- the teams navigated it well. We've been able to increase the procedures and lower our cost because we're on these big contracts, these big tenders and we'd be able to pull out costs, increase volume, even though pricing is down. And it remains growing at the corporate average right now and that average for the company is improving, as you see. And profitability is also strong. For years, there's been this misconception that China is not profitable. Prior to VBP, I admit it was even more profitable, but it's still accretive from a profitability standpoint, and it's a growth region for the company.

Next up, we have David Roman from Goldman Sachs.

I wanted just to come to the comment you made on CAS during the prepared remarks. I think you talked about visualizing, other catheters on Affera? And how you're thinking about integration of some of the investments you're making on expanding the accessory business within CAS as well as the potential to integrate some of the other established technologies on to Affera?

And then maybe I'll just ask my follow-up front here. I know, Thierry, you talked about tariffs as you reflected in the guidance, but there do seem to be a lot of other unresolved considerations on tariffs such as USMCA and then 232. So maybe just your latest updated thoughts there would be helpful.

Well, first, on CAS, I mean here Affera platform, like we look at it as a 3 in 1 kind of -- we view it as the premier platform out there, right? And I think the numbers are bearing that out. And we've worked hard to get to this point, and we're still in the early innings of the launch of Affera in the U.S., as Thierry pointed out, and globally.

And there's a couple of vectors of growth. One is the innovation you pointed out. We're really surrounding electrophysiologists. So we have more catheters coming out, Sphere-336 in Europe. We started the trial in the U.S. for a single shot that was right at our biggest competitor. The mapping, we just launched our second-generation mapping software. And as you pointed out, David, it's got this ability to sense other -- pick up other catheters. And then we're bringing in -- we made 2 investments in ICE catheter companies. So we're going to build out our ecosystem and surround the EP.

In terms of -- if your question is about are we opening the system, I don't think we have plans for that right now. I mean, it's -- we're really building out our proprietary technology and ensuring that we have that tight workflow. That is our plan to have that tight workflow and get the best clinical outcomes and the best experience for the physicians.

Yes. And on the tariff side, I think we mentioned it in the commentary. Look, we continue to monitor the environment there, which is still a little volatile, as you mentioned. I think we continue to look at the 232 situation. On the flip side, we've incorporated sort of a status quo in tariffs. So we haven't incorporated any potential upside for reimbursements that could occur in which we have applied for. So we we took a balanced approach on it, I would say.

Our next question comes from Robbie Marcus at JPMorgan.

Great. Two quick ones for me. First, Jeff, I wanted to ask on MiniMed. I see consensus numbers have strong organic sales growth, margin and free cash flow improvements over the coming years. If that's the case, can you just remind us what's the rationale for separating it here? When do you want to keep a business with strong improvements and inflections in profitability and growth going forward?

Look, I mean, we're separating it not because of our confidence in the outlook of the business. I mean, to your point, we think it's going to do really -- it's doing well today, and it's going to accelerate from here with the product pipeline that they have, which I'm sure Kweli will give updates on the call after this. I mean -- but it's the best we've seen, and it's comprehensive across all aspects of managing insulin independent -- or insulin-dependent patients. So we feel really good about that.

I think as we focus, we have a lot of growth drivers to focus on. And these other growth drivers that we talked about today, whether it be CAS or RDN, Hugo, Altaviva, Stealth AXiS, all of them, I think, take more advantage of and benefit from either technology platforms that cut across the company, especially in robotics, in areas like that or our commercial footprint, where MiniMed does not really capitalize on that as much.

And the second is, look, we are very disciplined around capital allocation. And it's hard to constantly allocate capital to something even though the growth is there, but the rest of Medtronic is growing much faster now. So the gap between MiniMed and the rest of Medtronic isn't as much as it used to be in terms of growth. And profitability, though, it's just a structurally lower profitable segment. And so it's kind of hard to allocate capital that way. I think both businesses will do better separated. And we've -- for our own reputation and patients, we did not -- we think we're separating at the right time. We've put a lot of time and money into the business. It's ready to go. It's got a great management team. And it's going to do well for patients. It's going to do well for physicians, and it's going to do well for shareholders. And the rest of Medtronic, we're accelerating and we're going to do well as well. So we're feeling really good about that decision and excited about the future of both organizations.

Fantastic. Maybe a quick one, Thierry, I look at consensus I realized you just guided to fiscal '27. I look at consensus for 7% EPS growth for 2028, realizing there's one fewer selling week, which is 150-plus basis points to EPS this year. Should we be thinking about a similar headwind next year? And how do you want people to think about year-to-year there just so we could get it correct at this update. Appreciate the questions.

Yes. Thanks, Robbie. Look, we'll give '28 guidance, when we give '28 guidance, it's kind of early, but just kind of directionally, some of the headwinds that we've got like tariffs, et cetera, disappear going into '28, and we expect the growth to continue, right? So we went through all the growth areas that we've got in the portfolio today. And a lot of these are in early innings, right? CAS is still going to continue to accelerate. Ardian is very early at development. Altaviva is also very early. And then we've got a long list of innovation that's kicking in, in the rest of the portfolio. So yes, there will be pressure coming from the 53rd week going away, but we have a lot of things going the other way. So we look forward to talking about that later in the year.

And our last question, we have time for one more, it's going to come from Mike Kratky at Leerink Partners.

Can you hear me right?

Yes.

Congrats on the strong quarter. Maybe just one quick one. But in terms of your commercial strategy and mechanical thrombectomy, to what extent is Leburn bringing differentiation to this market? How are you thinking about your ability to carve out share of the market with 2 well competitors and what could that opportunity look like?

Yes. Look, we're not -- we don't -- we try not to guide at a product level. So I can't get too specific there. But I do think we have a strong commercial footprint out there in our Peripheral Vascular business. And this is a product we've worked on for a while, and it's gotten -- we're getting great clinical results. Physicians feedback is good. And I think we're putting that product in the bag of our Peripheral Vascular business, plus it's got -- we got this agreement with Contigo that's also helping that business and help me with -- no, this is Peripheral Vascular. So we've got a number of new products there. It's not just one thing. So I'd look at the business and the direction of travel of the overall business, putting more competitive products in that scaled sales force.

And it's -- I appreciate the question, Mike. We don't get a lot of questions around Peripheral Vascular, but it's kind of sneakily kind of improving their growth profile, which is part of the exciting story of Medtronic. As we -- you've got these 3 groupings. You've got these big growth drivers that we are all talking about like CAS and now you're going to hear more about Ardian and Hugo now, but both those guys had good fourth quarters. And then you got Altaviva and Stealth AXiS, these thorough breads coming out of the gate hot. And then you've got our big businesses CST, which we kind of just talked about, Surgery is doing well, and cardiac rhythm is just crushing it.

Like where other companies see a mature market. Our cardiac rhythm management sees opportunity and innovates and drives to market. We're not worried about competition, it's about innovation and growing that market, lowering any kind of bar for pacing and CRM, and it's a wonderful story. But then the rest of the company is also doing well. There's puts and takes, but it's also doing well. Peripheral Vascular is part of that story of adding new products to the business. And it all comes back to our capital allocation strategy of feeding the big markets in the hot hands, but also making sure that there's the right amount of capital for the rest of the businesses. And hence, focusing the portfolio to enable that, getting back to the diabetes question that Robbie had. So I appreciate the question, Mike, and I'm sure the Peripheral Vascular team does as well.

Great. Thanks, everyone So with that, I think I'm going to turn the call back over to Geoff for some final remarks.

Okay. Well, first of all, thank you for joining the call and all the questions. It was a really important moment for the company as we are really accelerated and really well positioned, putting up big numbers and really well positioned for the future and particularly in a tougher market backdrop. So I appreciate your support and your continued interest in Medtronic. And with that, I'd say you have a great rest of your day, and thanks again.

All right. I think we can kick things off. But thank you all for joining. My name is Mike Kratky. I'm our Senior MedTech Analyst at Leerink and thrilled to be joined today by Medtronic's CFO, Thierry Pieton. So thanks so much for joining.

Yes. Thanks for having me.

You just passed the 1-year mark at Medtronic. We'd love to maybe kick it off by hearing from your perspective, how the business has evolved over the last year. And as you look out over the next 12 months, what gets you most excited?

Yes. Look, first of all, it's been an interesting 12 months. I mean we've had a lot of things going on between sort of accelerating some of the new product launches and some of the portfolio actions that we've taken that I'm sure we'll talk about, the IPO of MiniMed and we're going back on offense in M&A, and we've done a couple of things in the last 3 or 4 months. So it's been pretty busy. Look, I think the business has growing confidence.

I think a lot of the work that has been done for several years in the past few years to build the portfolio and to reinforce some of the operating mechanisms in the team and to work on R&D on some of the innovations that we're launching now, it's starting to pay off. And I think there's a lot of excitement in the company. Performance has been improving from a top-line perspective over the last few quarters. And so I think it's confidence building, and I think the mood of the team is super positive and leaning forward.

Understood. And yes, talking about M&A, I mean, last 3, 4 months and even the last 3, 4 days, the Scientia acquisition. So maybe actually to kick off, would love to hear how you think about that business and why it might be a good fit for you guys?

Yes. So I think Scientia is the perfect example of what we want to do, right? So what it brings in -- so first of all, stroke is a massive condition out there. Millions of people have strokes every year. And time is really of the essence when you have a stroke. So every minute that you wait to fix the issue costs you millions of brain cells. So for us, having in the portfolio a very differentiated access guidewire is really critical. So we have good equipment for the thrombectomy piece of the business, so treating the blood clot or the hemorrhage, but we didn't have access. And I think now this is bridging that gap.

And what we're seeing is because of how crucial it is to have access as quickly as possible, the access equipment actually dictates what equipment is going to be used afterwards to treat the problem, right? So for us, it generates a lot of synergy. They have a unique technology, which is a great balance between the stiffness of the catheter and the flexibility to access different tortuous parts of the brain as quickly as possible.

And so it's -- yes, it's great to add that to the portfolio. And so they have their own base of customers. Some of the customers are common. We have our own -- they have their own. So there's going to be a commercial aspect to this. Our sales reps are going to be able to carry their product in addition to the existing range. And the financials look good. So for us, it's the exact type of example of deal that we want to be doing on a go-forward basis.

Perfect. And I might have more on M&A later, but I did want to jump in on your guidance and some of the most recent color during earnings that you provided. So I'm curious how you'd kind of characterize some of the top and bottom line growth expectations that you've set forth for next year and to what extent that kind of factors in the extra selling week?

Yes. So first, and I'm sure we'll go through some of these things in detail afterwards, but it starts with accelerated growth, right? And what we've said in the 3Q earnings call is that the organic growth that we're going to experience in '27 is going to be higher than the organic growth of '26. So right now, for '26 -- or fiscal year '26, we're calling 5.5%. So we should be north of that. And that's excluding the impact of the 53rd week. So it's true organic incremental growth. And I'm sure we'll go into the details, but it's on the back of CAS continuing to accelerate in the business because we're still in relatively early innings of the growth of that business, and we can drill into the details.

But in addition to that, in the third quarter, we did 6%. In the fourth quarter, we'll do about 6% and the next generational growth drivers, so Ardian, Altaviva, Hugo haven't really kicked in yet. So what you'll see in fiscal year '27 is starting to see the impact of these other growth drivers, plus a whole bunch of innovation that we've got in the rest of the portfolio in peripheral vascular health, in neurovascular, et cetera, that are going to help as well.

So we feel confident that we've got a great roadmap to continue to accelerate growth in '27 and beyond and again, in '27, excluding the impact of the 53rd week. If you look at the income statement, gross margins are getting better. So right now, the pressure that we've got from diabetes and CAS mix is going to get better. As that gets better, the progress that we're making operationally through pricing and cost out to improve gross margin is going to show up, right? And we'll get some leverage on the overhead part of the income statement. We'll keep investing in R&D, but we'll more than offset that with leverage on SG&A. So that's how operationally we're going to generate some leverage at the operating margin level.

Below that, there are a few moving parts that I tried to explain in the Q3 earnings. We're going to have some dilution from the M&A activity that we've had. There is some dilution that's coming from the diabetes deal, in particular between the IPO and the split. And we'll have some carryover from the tariff effect going into '27. And we're going to use the 53rd week to offset part of that at the EPS level. And when all is said and done, net-net, we're committing to the high single-digit EPS growth for next year.

Very helpful. So maybe a good segue to the CAS business. Obviously, it has been a huge source of momentum for you, fifth straight quarter of accelerating organic CAS growth, close to 80% in fiscal 3Q. So would love to hear how you're thinking about the elevated growth rates for that business moving forward as you kind of lap some of these tougher comps, the durability of growth and how you can sustain some of that momentum?

Yes. So first, it's a growing market. So in Q3, the overall market was $13 billion, it grew 20%. We see it continue to grow in the high teens going into '27. So the pie is getting bigger. Within that pie, we've got a very unique offering now with the versatility that Sphere-9 brings. It's the only catheter that integrates the mapping, PFA and RF, which is a big deal for the physicians because in a lot of procedures, you don't know if PFA is going to be enough. And so having the security of being able to do the complete treatment without putting the catheter out and putting another one in is a big deal.

And our data shows that in 50% or 60% of the procedures done with Sphere-9, there is actually utilization of both PFA and RF, right? So it's a big security. The physicians love it. And so that business is taking off. And it's -- again, it's in the early innings. We're still building the installed base of capital equipment. We're still working primarily on key accounts. So in the U.S., 70% of the business is with 30% of the accounts, and we're focused mainly on those. So we haven't really started going to the rest of the customer base at this stage. And even the key accounts, today, they have 1 or 2 pieces of equipment, and they want to get a second or a third or a fourth. So we feel there's a lot of runway.

At the same time, we're expanding geographically to countries like Japan. We're expanding the indication to VT, and we're about to launch the next generation. So we just got CE Mark for Sphere-360 in Europe, and we started clinical trials in the U.S. So we should be able to launch that product sort of in 18 months from now. So yes, so we see continued increased growth from that business going forward. Obviously, the percentages at one point will not be the same because the base is growing bigger and bigger. But in absolute dollar values, it's becoming a bigger and bigger contributor to our growth, which means growth acceleration for Medtronic.

Understood. Yes, really, really helpful there. And I guess just digging in on specifically the PFA side within U.S. ablations. How do you think about where overall market penetration is today and where that could be, call it, in the next 12 to 24 months?

Yes. So I think today, it's in sort of 50% to 60%. And we think ultimately, it will get to 80%. So there's still a lot of margin for growth there.

Got it. And then maybe within that, you obviously talked about some of the Affera Sphere-9 dynamics has been gaining significant market share. So how do you think about that continuing over time? And what do you think Sphere-360 could ultimately mean for your business in terms of further market share?

Yes. So on Sphere-9, as I said, the reality is it's a very differentiated product today, and it's still a market where technology counts, right? So the physicians want the best technology, and that's what Sphere-9 is today. We know that the competition is working on competitive products. But from our -- from the data that we've got, it's still 1 or 2 years out. In the meanwhile, we're working on 360. 360 is a large tip rotation-free single-shot catheter. It's going to cut the procedure time even versus Sphere-9 by 2/3. So it's an incredible product from a speed of procedure perspective and in particular, adapted to more simple procedures, et cetera. So we're very excited to the incremental contribution that we're going to get from 360.

Understood. And maybe just one of the last ones on PFA. But as you think about potential bottlenecks in the market, whether it's capacity or otherwise, is there anything that you see as kind of a key point of sensitivity for market growth over the next 12 or so months?

For market growth, I don't know. But for our growth, manufacturing is not an issue at all. We've got plenty of capacity now to produce both the capital equipment and the catheters. The long pole in the tent, so to speak, is the mappers. And so we're hiring hundreds of mappers. But we're on track. And if you're a mapper today, part of your remuneration depends on the number of cases that you do. And so you typically want to be with Medtronic because that's where the growth is. So we're able to attract mappers. But again, that's -- if there was going to be a bottleneck at one point, that would be it. But today, we don't see that as a problem.

Got it. Very helpful. I'd love to shift to your renal denervation business. Could you share some of the early takeaways from the commercial launch so far and just the level of demand you've seen?

Yes. So first, so we look at the entire funnel, right? So from the very top, how many customers are interested in the procedure. And for that, we look at the number of clicks we've got on the Internet, and we look at every stage of the funnel down to the number of cases that we actually do. At the top of the funnel, the traction is tremendous. So in between Q2 and Q3, we went from 50,000 clicks on the website to 2.2 million, right? So there are a lot of people out there that have this problem and that are interested in this kind of life-changing procedure.

So we're continuing to do some direct-to-consumer marketing to continue to build that. But really, it's all about creating the capacity to do the procedures down in the treatment centers. So we're opening accounts. We've opened more than 200 accounts. We're putting physicians in -- helping put them in Physician Finder so that people can be connected to them on the Internet. We've got more than 150 in Physician Finder today. But the -- again, the longest pole is getting the first -- getting the reimbursement done. And it's a new procedure. And so what we see is once a treatment center has done one procedure and successfully gotten reimbursement, then the second, the third, the fourth happen pretty quickly, but they don't want to take the risk of not getting reimbursed.

So a lot of the resources that we're putting are dedicated to facilitate the reimbursement to help the customers get it as quickly as possible. But we're getting tons of traction. I mean the procedure volume is going up. The accounts are going up. The physicians are happy with it. The feedback that we're getting from the procedure is excellent. Competitively, we're very, very well positioned. So we're excited about it. But it's a new therapy, so it takes a little bit of time to build that market.

Yes. And I'd love to dig in on some of that. But have you quantified how large that business is today? As you think about your guidance and what you're factoring in for next year, generally, how large you expect it could be by the next 12 to 18 months?

So for Q4, it's still a relative -- a small number. Going into '27, it starts being noticeable, but it will take time. And we haven't given any specific guidance. And as it becomes a bigger business, we'll get more details, but it will start to be noticeable in fiscal year '27.

And then the other point you made is just on the competitive landscape and how you've been tracking above expectations there. So I'm curious what factors really seem to be driving that.

Yes. So look, so first of all, I think Medtronic, it's been a long time coming. So we have 15 years of clinical data. So we have far more data than any competitor out there. And what we're seeing is that we're the only OEM that provides a therapy that keeps having a positive impact after the procedure. So you do the procedure, hypertension goes down. And in the months afterwards, it keeps going down. And even up to 3 years afterwards, you keep seeing a benefit from having the procedure done with simplicity. What we're seeing is that's actually not the case with ultrasound. What we see is actually the reverse. You have an initial kick from a hypertension perspective when the procedure is done, but then it creeps back up.

So for us, from a technology perspective, it's very encouraging. But we're not standing still. So we're developing radial access to make the procedure quicker. We're looking at using simplicity to do ablation in other organs to further increase the impact. So we want to lean forward and capture that business opportunity in the biggest way possible. It's 18 million patients in the U.S. with uncontrolled hypertension. So that's a massive pool.

Yes. Yes, no question. So maybe switching to TAVR. I mean this has maybe been one of the businesses that's been a little bit more variable. You talked about some of the competitive pressures as one of the main culprits recently. So how do you plan on navigating some of the recent challenges you've seen there? And what's the right way to think about the growth rate for your U.S. TAVR business moving forward?

Yes. So look, I think we had several good quarters in TAVR, in particular, in fiscal year '25. It was high single digit, and I think the business was performing well. I think it's been a bit slower in the last few quarters. And I think, candidly, we need to do better, right? So there's -- it's one of the performance areas that we need to continue to improve. I'll take a second to hit on the low-risk study on Evolut because there was some, obviously, news around that. For us, -- it's a valve that we stopped making a long time ago.

Now we sell Evolut FX. It's the fourth iteration of products since the one that was concerned with the study. We've changed the procedure. There was a part of the procedure that -- where some physicians were using balloon expansion after the implant to expand the valve, which is part of the root cause of some of the issues that have been highlighted. And so for us, old procedure, old products, now we're on Evolut FX new procedure. So we're still positive about the performance of that valve. I think it's highly possible that we'll see some short-term disruption while people get the terms with the data.

But long story short, this is a great space for us. Structural heart, generally speaking, is a great space. Medtronic has good market share, good reputation. We made the investment in Anteris recently because Anteris provides a great short valve that's balloon expandable. Balloon expandable is about 70% of the market now. So that's us showing that we want to go in that part of the business as well. And we're investing in mitral. We're investing in tricuspid. So again, we're committed to Structural Heart. It's a great franchise. It delivers great margins, and we need to go back up to the performance levels that we should be at.

Very helpful. Another area within cardio that I feel like maybe we got less color on sometimes is mechanical thrombectomy. We've seen that this has been a really attractive market. So I am curious how you think about your place in the market ahead of the Liberant full market release and the commercial strategy there?

Yes. So Liberant, for us, combined with Excipio, which is the mechanical thrombectomy catheter, brings the incremental benefit of having the suction. And so it's a key unlock for us from a product perspective. And the physicians are delighted to be able to have those 2 combined together. Medtronic also has a good reputation in this area. So we're excited about what Liberant brings actually both in the peripheral vascular health segment of the business and also in neurovascular. So it's sold by the 2 teams, and we're excited about that.

And maybe switching over to neuro. Altaviva, another product that has been clearly a big source of enthusiasm. So curious in terms of as that scales, what investors should be keeping an eye on to gauge how large this commercial opportunity could be for you?

Yes. So in a way, it's very similar with Ardian because you have to build awareness to the therapy on one end. And on the other end, you need to train the urologists and the physicians to do the procedure. It's a very simple one. And you also need to help them get the first reimbursement and get through the VAC process. And that's what we're seeing now. So we're sending clinical specialists and sales reps to the accounts and opening a lot of new accounts and helping them get the first reimbursement.

And afterwards, we see the cases take off. And again, whereas Ardian is 18 million potential patients in the U.S. alone. For Altaviva, it's 16 million. 5 million of those 16 million are actually at a severity of the condition that they're already kind of applying or eligible for that type of procedure. So it's another massive, massive opportunity for us that will start being visible in '27 and will contribute significantly after that.

Understood. And it's a space that there's a few other potential products and competitors out there. So how do you think you'll be able to build market leadership here just based on the product profile that you have?

So look, the product is dramatically different from the competition. One, it's activated right away. So you don't need to come back several times in the weeks after the procedure to have it adjusted, et cetera. You come into the office, you have a small incision, it's inserted above the fascia. It takes a small amount of time, and then it's immediately effective, right? Second, the battery lasts 15 years. where the competition is like 2 to 3. So you don't have to remove the device for 15 years.

You come once a year to the urologist, have your checkup, do the recharge of the battery by induction and you're good to go for a year, right? It's also MRI compatible, fully MRI compatible, which is a big deal because for the category of patients that have UUI, typically at one point, you're going to have an MRI exam done for something. And so the fact that you could do the full MRI without having to remove the device is actually a big deal, right? So yes, I mean, I think there's -- it's a very differentiated product on the market today. So good to have it in the portfolio.

Yes. Understood. And maybe another product that I feel like we're hearing more about recently is the Stealth Access platform. So, curious about where the differentiation comes from there and how large that could be really over the next kind of 2027 type time frame?

Yes. So 70% of procedures that are done in CST today are -- depend on the navigation element, right? So having the best navigation system is really key to being sticky with the customers. The CST team has been on this journey for several years now. And what we've seen is by integrating imaging, mapping and now robotic assistance with Stealth Access, you basically give much better patient outcomes, give a lot more information to the surgeon so that the procedure can be successful, help with the workflow of the hospital. And so it's made our CST business a lot more sticky, and I think you've seen it in the competitive dynamics. And we've been growing healthy mid-single digits for several years. The margins keep improving. And so Stealth Access takes that ecosystem formula to the next level, right?

And so the AI is going to relieve the surgeons from a portion of the mental load that they have to deal with. The mapping is going to help them figure out the best way to actually carry out the procedure. And the robotic assistance is going to further improve their skills. So we're very excited about that product. And it's what's going to help us build the overall franchise. It's not just that product for that product, but it's also the impact it's going to have on the pull-through of the implants.

Yes. And maybe that's a good segue to your MedSurg business and talking about what Hugo might mean for that business, both stand-alone revenue contribution and then also kind of a balanced MedSurg, broader offering.

It's a great parallel. And I think Hugo brings to MedSurg exactly that what Stealth Access is bringing to CST. So it's the opportunity to provide an ecosystem that makes the outcomes and the workflow better for the hospital. Look, now Hugo is FDA approved in the U.S. It's a massive step because 90% of robotics are in the U.S. from a procedure perspective. We're the only OEM that can offer open surgery, laparoscopic, and robotically assisted. In an area where it tends to be partnerships. So people go with J&J or with Medtronic for the instrumentation, and they tend to stick to one of the two. So having that full offering is a big deal.

And so now we've started commercializing Hugo in the U.S. We've done the first installations, and we did the first procedure just before we had the earnings release and the outcome was very positive. And look, it's a great step forward. There's a second player in that area now, and we're excited about that. But I want to stress that it's -- we want to be very successful with our key partners with Hugo. So it's not about flooding the market as quickly as possible. It's about picking the customers that want what Hugo brings to the table because Hugo is differentiated. And we want them to be super happy with the outcome so that we continue to build on the partnerships that we've established over time.

Understood. And just under 5 minutes remaining, but I would love to hear kind of the perspective, the latest thoughts on Diabetes business and MiniMed and what that might mean just in terms of financial implications for the business?

Yes. So look, we're happy that we successfully completed the first phase of the separation of MiniMed. We had committed that we would separate the business by the end of calendar year '26, and I think now we made a significant first step there. Obviously, when we launched the IPO, we didn't know that the conflict in the Middle East would erupt. And so it did create some market disruption.

But at the end, we got a good deal. It's the second biggest MedTech IPO in history. And I think it's a testament to the turnaround that has been carried out in that business. It's got a great management team with Que as a leader. It's got a fantastic product roadmap ahead of it, which puts it in a position where it can really guarantee time in range for diabetic people in a very differentiated way. And so I think it's got a lot of runway. And we look forward to the second step of the transaction, which is the split. I think we should target sort of 6 months after the IPO, market conditions providing, and then we will have completely separated the business. It will be an accretive deal for Medtronic over time.

The impact on '27 depends on the timing of the split because the EPS accretion that you get is based on the number of shares -- share reduction that you get. So when we do the split, we exchange Medtronic shares for MiniMed shares; that reduces the number of Medtronic shares and, therefore, increases the EPS. But the number of shares is calculated on a 13-month rolling average. So you only get the full impact of the accretion after 13 months.

So in a way, the earlier we do it, the bigger impact we will see in '27. But at the end, this is about the strategic move that we're making, right? It will be accretive, but more importantly, it puts both Medtronic RemainCo and MiniMed in a position where both businesses will have their own capital allocation, their own investors, et cetera, and are poised to be successful. So yes, I think we're on track, and we're happy to see it move.

Understood. Well, we started the conversation on M&A, and I'd maybe love to wrap up there. So in terms of how you think about your appetite for business development, the size of the deals that you might be looking at moving forward -- is yesterday's Scientia deal a good way to think about what you might be interested in the near-term, what a larger deal might look like for you?

Yes. So as I said, Scientia is the perfect example. There's complementarity from a product perspective; from a commercial standpoint, we can help at one point, scale the manufacturing. And so there are a lot of synergies. And so that's the poster child of what we would be doing. Another example would be Affera. We had PulseSelect that was an organic development on one side and Affera, which was an acquisition, gave us 2 shots on goal. It turns out both of them are successful, which is great.

And so that's what we're looking for. Anything that can help us create ecosystems in our portfolio that make our products more sticky and accelerate our WAMGR, right? So that's kind of the -- those are the criteria for the type of business. And then from a financial perspective, we have high thresholds from a return perspective. And from a size standpoint, we're looking at medium-sized tuck-in. So basically kind of $3 billion to $4 billion max in terms of deal size, but around $1 billion to $3 billion is probably the sweet spot. But we'll also do venture investments for more upstream type of ventures, et cetera. But we're going back on offense, and it's great to see.

Understood. Well, certainly a lot to be excited about. I know we're up on time. Thank you so much for joining us, and thanks all for coming.

Yes. Thanks, everyone. Thank you.

Good morning. Thanks, everybody, for joining us. I'm very pleased to have with us this year, Medtronic and in particular, Thierry Pieton and who's CFO and EVP. My name is Matt Miksic. I cover U.S. medical devices. So thanks, Thierry.

Thanks for having me.

Yes, of course. Our pleasure. So I wanted to start with question that we're starting a lot of the sessions, not every session with is just the events of the last week. So maybe the 2 key questions are exposure to Middle East, to the extent you can put some shape or size around that and then potential implications, not so much of what we've seen in the last week, but if price of oil were to remain higher for longer and maybe drawing on the experience that you had in 2022 and how this might be similar or different?

Yes. So look, the Middle East region for us is kind of 2% to 3% of our overall revenue for the year. So it's a relatively minor portion. And I would say within that 2% to 3%, there's a large portion that's kind of health care necessary products. So we don't anticipate a large impact. What could have caused an impact would be logistics issues. So if you're unable to ship. But it feels like today, we've got a good grip on how to fix those.

So I would say, short term, we don't see a very large impact coming from the conflict from that perspective. On the price of oil, it's the sort of petroleum derivative content in terms of raw materials and our products is less than 1% of our cost base. So -- and we've got sort of contracts that are in place for the year to come, generally speaking, with productivity commitments, et cetera. So again, we don't foresee that as a strong negative. We did launch the IPO of the MiniMed business just before the conflict erupted, I want to say. And so the result is that there was some pressure on the pricing of the IPO.

That being said, we made a commitment from a strategic perspective to separate that business because we think strategically, both MiniMed and Medtronic are better off living their life separately and having their own investor base and having their own capital allocation, et cetera. So we had committed to getting the overall separation done by the end of calendar year '26.

And so we decided to move forward with the IPO within that context. And we're happy we did it. At the end, we got a good valuation for that business, and we're very confident in the way forward. And so we've set the first steps or path to completing that separation, and I think it's a very positive one.

Okay. That's helpful. So -- and back, just to clarify on the percent of your cost base, you're talking about the percent of your P&L or your percent of your COGS?

Percent of the cost.

Of COGS manufacturing. Got it.

Small portion.

Sure. No, that's helpful. And then shipping and logistics, any -- there were some rising shipping costs, much different situation in '22 because there was also componentry shortages and all kinds of other things that were making it more difficult to get parts globally to where they need to be. Any sense that extended period of time where shipping costs are more expensive?

No. Look, and again, shipping would be, again, a relatively minor portion of our cost base. But I think back in '22, the issue was accessing certain raw materials, and there's not really that problem in this case other than, again, petroleum-derived products, which is small for us.

So no, we don't anticipate a major impact from that. In the regions, there are several countries where we work for distributors. So we're able to make sure that they have the right level of inventory to be able to cope with some fluctuation in access from a logistics perspective. But at this stage, we're able to ship in the region.

Okay. And then finally, the timing, like things have to work their way through work in process and cost of goods and inventory. Is that if there were an effect now, would this be a '27 event?

It would be. I mean, typically, our inventory cycle is about 35 weeks, right? So it would take 7 or 8 months before we would see the impact in the income statement.

Got it. Okay. Well, we -- there's a limit to how much I can dig into the MiniMed transaction, given our involvement in that transaction. But I would ask from a Medtronic perspective, this wasn't sort of just to put that -- underscore the fact this wasn't a one-and-done event, right? So it priced at lower than was expected. But your -- the time frame for your divestiture, if you could talk about the second stage and the benefits that you expect to.

Yes. So look, so first, again, the main rationale behind the deal is, first and foremost, a strategic one, right? It's about focused capital allocation, and it's about making sure that these 2 businesses are going to be as successful as possible on their own. And I think clearly, MiniMed is B2C. Most of the rest of Medtronic is B2B.

The margin levels are pretty significantly different. So MiniMed represented about or represents about 7% of our revenue, but kind of 3% of our EBIT. So it's less profitable than the rest of the business. The R&D intensity in MiniMed is a lot higher than in the rest of Medtronic. As a percentage of revenue, it's about twice the spend of the rest of the portfolio.

So it's a relatively minor part of our business that took a significant portion of our capital and of management attention. And so the decision was made to separate and all those criteria remain obviously completely the same. So the path going forward is -- so we just did an IPO on 10% of the capital. If we were to exercise or if the underwriters were to exercise the green shoots, that would go up to something north of 11%.

The big part of the deal is the second part, which is the split of about 90%. So what's going to happen there is we will offer the option for Medtronic shareholders to either keep their Medtronic shares or opt for a conversion into MiniMed shares with a discount to incentivize them. And so the intent is to do this. I would say, I would target roughly 6 months from the IPO from an ideal timing perspective. The result of that will be that we'll have a share count reduction as people convert from Medtronic stock to MiniMed stock. It will mechanically reduce the number of shares that Medtronic has, which will mechanically increase the EPS.

And so net-net, we view this as an accretive deal for Medtronic shareholders. And again, it gives access to MiniMed to its own capital, to its own shareholder base and investors, et cetera, and enables us to redeploy a portion of the investment and a portion of the capital towards elements of the portfolio where we have an even stronger right to win and better economics, candidly.

Okay. And obviously, it's a slightly -- it's growing a little faster than corporate average at the moment. So maybe talk about some of the commitments that you've made, preliminary commitments for 2027 in terms of driving leverage to the operating line, leverage to the bottom line and how we can get into and then maybe the first part of the question because there's a lot. And then we'll get into how the composition of your other growth programs can kind of get you to where you want to be on the top line. But first in the leverage part.

So look, first, the impact of the deconsolidation of MiniMed. So MiniMed will be deconsolidated once we complete the second stage, right? So the split. When we made the announcement of the deal, the calculation that we had made was that MiniMed was contributing about 40 basis points of growth for Medtronic, which is less than CAS and less than what we expect from a number of the other growth drivers, which we'll talk about later.

Since then, the growth has accelerated for Medtronic. So you've seen the growth profile get better and better. We were at about 5.5% in the second quarter. We did 6% growth in the fourth quarter. In the third quarter, fourth quarter seems similar. And so we're on an acceleration path. So if you look at the algorithm going into '27, growth is going to continue to accelerate.

So I made this comment in the 3Q earnings call. We expect the organic growth in fiscal year '27 to be higher than the organic growth in fiscal year '26. And that's even excluding the effect of the 53rd week because I know I've had a lot of questions. So on an apples-to-apples basis, you will see an acceleration of growth. We expect the gross margin profile to improve. The things that are hiding the operational improvements that we're making in gross margin today are basically the negative mix coming from MiniMed, and that will solve itself with the split.

And we're seeing mix pressure coming from the growth in the cardiac ablation systems part of the business, which will get better towards the second half of fiscal year '27 with the mix between capital equipment and the catheters starting to go more towards the catheters. So a lot of the improvements that we've made in net cost out in pricing, et cetera, will start showing up in the gross margin. Then if you keep going down the P&L, we've said that we will continue to increase R&D as a percentage of sales. And we'll keep doing that in '27, but we will reinvest only a portion of the leverage that we're getting from the volume growth into the R&D spend, right?

And then on the SG&A line, we'll continue to fund the growth areas. So we'll fund CAS and we'll fund Ardian and we'll fund Altviva and Hugo, et cetera, to capitalize on these big opportunities. But net-net, the leverage that we can get on the G&A line, which is really the functional cost will more than offset the resources that we're putting on the sales and marketing side.

So net-net, we expect SG&A to provide some leverage going into fiscal year '27. So op profit should look better. Below the line, tax will be more or less the same, slightly worse, but we're kind of stabilizing the tax line. On the interest side, we've got a bit of pressure like a lot of the peers coming from the fact that we're refinancing debt that was almost at 0% with debt that's at 3% to 4%. But all things being equal, that puts us in a position to have some EPS leverage going into '27. And then we've got a number of moving parts, right, which I alluded to in the 3Q call. So we will have carryover from tariffs.

So this year, tariffs were about $185 million. We forecast about $300 million going into fiscal year '27, so $100 million to $120 million of carryover. We will have some dilution coming from the M&A activity that we're doing. You probably saw this morning the announcement on Scientia. We've embedded some pressure coming from the period between the IPO and the split on the diabetes deal because a lot of the benefit from the split of diabetes comes from the share count reduction, and that's calculated on a 13-week rolling average.

So we will see that benefit and the deal will be accretive, but it will come gradually after the split. And on the flip side, we'll have a benefit from the 53rd week that we have, which is something that happens every 7 years for Medtronic. Net-net, including all of this, we're committed to high single-digit EPS growth. So that's kind of the algorithm for us.

Okay. Well, then there's a lot in there. And one of the things I think that surprised folks was given the strength in CAS, and of course, you have Altaviva, you've got Ardian, which continues to ramp. You've got other growth programs. But just given the strength in CAS and the comps that folks are anticipating for next year, the concern was, well, how can you grow faster? So maybe there's a few things that are different about the way CAS is growing for Medtronic than, for example, the way CAS grew for Boston.

And I think it has to do with the sort of account wins on the mapping side as well as on the catheter side. So maybe talk about like how has that been, how has that maybe tempered your growth as strong as it's been? And how does that sort of help you drive more sustainable high growth over the next 12, 18 months?

Look, we're -- so first of all, we're the fastest-growing franchise in this incredibly attractive market. And so we're thrilled with that. It's a fantastic franchise. It's dilutive at gross margin, but it's super accretive at the operating margin level.

So we're happy with it. I think what puts us in a different spot is kind of the product portfolio that we've got. We've got PulseSelect single shot, very competitive product. Then we've got Sphere-9. The big advantage of Sphere-9 is that it's dual energy. So it's RF and PFA, and it includes the mapping.

So for a physician, you don't know how all of the procedure is going to go when you started. So having a catheter that enables you to do the mapping, to do the PFA, but also to do some RF if you need to in the procedure is a big differentiator. The alternative is to do the mapping with one catheter, pull it out, do a PFA ablation. And then if that's not sufficient, put it out again and put a third catheter.

So it's not great, it's not as good for the patient. It's not as good for the hospital economics because it's more expensive. It's not as good from a procedure time perspective. And our data says that in the case of Sphere 9, 50% to 60% of the cases that are being done are dual energy. So the physician is having to use both PFA and RF. So it's just a massive differentiator. And originally, we got some comments on, is this a niche product for high-end procedures.

And clearly, the experience of the physicians is that it's not. It's a workhorse that you use when you don't know what the outcome of the procedure is going to be. And then on top of that, we're about to -- we've just received CE Mark for Sphere-360, which is the next-generation single shot. It reduces significantly the procedure time even versus Sphere-9. We started the clinical trials in the U.S. So we should be able to commercialize that product in about 18 months from now.

We're continuing to expand the usage of Sphere-9. We're launching it in Japan. We're looking at expanding indications to VT. So we're in absolute sort of growth mode for this business. And we're really -- we really feel like we're at the beginning of the growth for this franchise. So we're super excited about the perspective. And clearly, our ambition is to take the lead in this market. And in the third quarter alone, we took 4 points of market share. So we're super excited about the franchise.

Okay. No, it's been a huge, huge win and -- but still constrained. So maybe talk a little bit about some of -- what are the -- not to make a big sort of negative point about it, but the reality is there are some hoops and hurdles that you need to go through to get a new center up and running, let's say, just using another catheter on a biosensor and Abbott system don't face. So maybe talk a little bit about.

Yes. So first, at the beginning, the bottleneck was supply chain and was the production of the catheters. It's 100% fixed. We have ample capacity to respond to the demand. The second, I would say, topic that you need to address is the mappers because you have a mapper that's physically present during the procedures. And since we're growing very, very fast, we're having to hire a lot of mappers. And a large number of those mappers require training.

Typically, it takes a few months before they're fully operational on our products. But again, there, we're on track. So we've hired hundreds of mappers since -- over the last couple of years, I would say, but most importantly, in fiscal year '26, and we'll continue to do that. And so we're in a position to continue to grow the franchise.

Now if you look at the market, today, about 70% of our revenue is coming from 30% of the centers, which are the big established centers. And we feel like we still have a large opportunity to grow in these large centers. Because typically, they have one piece of equipment today, and they're looking to add the second one and the third one. So there's still significant opportunity to grow with the large centers. But now we're starting to look at smaller accounts as well.

And so again, large opportunity to continue to grow from a commercial perspective. And even in the ASCs, which it will take time, but it will, I think, become a larger portion of the market over time. We've got a perfect catheter for them, which is PulseSelect with great economics. So I think that the product range that we've got with Sphere-9 and PulseSelect today and shortly with 360 really puts us in a position where we can address the different parts of the market.

So we could spend another hour talking about cast, but we don't have another hour. But just lastly, on mappers. I think investors and we sometimes think about this as, okay, so it's hard to hire experienced mappers. Some of your competitors are doing their best to lock down those resources and retain them. But I would imagine and what we've gathered is like the ability to hire isn't a constant.

It's changed, right, over time, just as Medtronic has gotten recognition for the success and the adoption and the growth in Affera has recognized in the community. So maybe talk a little bit about is the ability to -- for people looking to join this team improving?

Yes. Look, if you're a mapper, you want to go where there's business. So your salary is going to depend on the number of procedures that you're able to carry out on a weekly basis, et cetera.

So right now, the mappers to want to come to Medtronic. And we know the competition is trying to do retention, et cetera. But look, we're on track. For sure, the mix between experienced mappers and less experienced mappers is gradually going to shift. And we've incorporated that in the way we do the training and the way we do the onboarding. So we pair the less experienced mappers with the more experienced ones, et cetera. But whereas it's an important topic and the team is very focused on it, we don't see this as a roadblock going forward.

Okay. Just a quick one on really important programs, Hugo and RDN in a couple of minutes we have left. So there's different opinions on both. Maybe talk about maybe most importantly, when and how will investors begin to see the sort of the positive benefits either to growth or to size or however you're going to be able to communicate about those businesses? Is that in calendar '27, we'll be talking about those?

Maybe color on when we start to see them moving.

Yes. So Ardian, short answer is yes, there will be impact on '27. I think it's relatively limited still for Q4. So we're not reliant on a large pickup for Ardian in the fourth quarter of this year, but it will start having an impact in fiscal year '27.

Look, it's a huge opportunity. Even yesterday at CRT, I think a lot of you might have seen the comments from the physicians everyone is super optimistic about the number of cases building. But it's a new franchise. So you need to set up the hypertension centers. You need to sort of build the referral pathways between the consumers that want to undergo the procedures and where the physicians actually are.

One of the hurdles is getting through the first reimbursement. So what we're seeing is when a physician has done successfully a case and gotten the reimbursement, then the second one and the third one tend to come quicker. And we're going through that buildup. And look, it's -- again, it's an 18 million patient pool.

So 1% of that multiplied by the price of the catheter, which is around $15,000 or $16,000 is a very significant opportunity for us. It's a good margin business. So it's a great franchise. And again, you'll start seeing the impact going into fiscal year '27. Hugo, look, we just got the FDA approval in the U.S. last -- at the end of last quarter. The U.S. is 90% of the global market. So it's a massive open door for us now. We did the first procedures at Cleveland just before the earnings and the way the product is received is very positive. There's someone else in that market now.

Noticed.

If someone has approval and can start selling an alternative. So we're looking forward to it. I will say, though, that it's a huge opportunity for us. So we want to get it right. So the first -- the approach is really to select the right customers, do the installation and the setup of the system in an optimal fashion so that there's perfect sort of customer satisfaction.

Our goal is to be the only OEM that can do open surgery, laparoscopic and robotic surgery. It's super important for our customers because they want to have that full solution. And now we're able to do it. And so we're in setup mode and starting to do the first installations. We'll take our time, but it's a big opportunity.

Okay. And the compulsion is, of course, to count boxes and talk about systems and things like that. But is the right way to think about this as entering a segment, entering an indication, if you will, within surgery that's going to show up as improvements in the overall Advanced Surgery business. Is that the right way?

It will help for sure, especially as we expand the indications. So today, it's mostly urology. We'll go to gyne and then we'll go to hernia and then general surgery. And our goal is to improve the coverage with these key accounts. And as this happens, you'll start seeing the effect in the financials.

Exciting times.

It is. Yes.

Well, thanks so much for taking the time.

Thank you. Appreciate it.

I'll leave it there.

Thanks very much.

Thank you.

[Audio Gap]

beyond cash, we're also making material progress with Simplicity Spiral for hypertension and Ulta Viva for urge urinary incontinence. Symplicity delivers a onetime durable minimally invasive treatment for hypertension and represents one of our largest growth drivers. Now this is going to be a contributor for years to come given the 18 million U.S. patients with uncontrolled hypertension. We're seeing strong patient outcomes in the field and the already in value proposition, it resonates with both physicians and patients.

Now we've got strong and growing clinical data, a broad label and expanding reimbursement all in hand Look, we've built the foundation. Now we're focused on growing this new segment and transforming the hypertension treatment paradigm.

We've recently activated our direct-to-consumer Go Beyond campaign in key markets around the U.S., which is resulting in a 50x increase in website visits versus the prior quarter. So a lot of interest coming in from patients. Building a new market, it does take time, but that is something Medtronic knows how to do exceptionally well. And in parallel to building out this new market, we're innovating for the long term. First, with our Transradial Catheter, which is on track to launch in the second half of fiscal year '27 and with our Spiral Gemini trial evaluating multi-organ ablation to further boost efficacy.

Now similarly, we are scaling Altaviva, our tibial neurostimulation device. Altaviva is a simple yet transformational option for treating urge urinary incontinence, which is a condition that affects 1 million people in the U.S. Altaviva is a very small device that requires no imaging, no sedation, activates the same day, is MRI ready and offers up to 15 years of battery life, the longest in its category. Again, we are receiving great early interest and feedback from both physicians and patients. And we are training doctors. We're educating and supporting hospital staff and investing in omnichannel consumer activation.

Look, it's early days for both of these launches, and we are focused on disciplined execution to convert early traction into procedures.

Now pivoting to Hugo. This quarter, our Hugo robot received FDA clearance for urologic surgical procedures, enabling us to begin our purposeful U.S. launch. And today, I'm excited to share that we've already completed our first installations and initial cases. As noted in our release this morning, last week, we completed our first cases at Cleveland Clinic, where surgeons echoed the strong feedback we continuously receive on Hugo's differentiation across multiple areas. This includes its flexibility, portability, open console and of course, our trusted instrumentation. Hugo is especially compelling when paired with our Touch Surgery Digital Ecosystem, an AI-powered data connectivity and analytics technology that is unique to Medtronic. This quarter, Touch Surgery installations increased over 20% sequentially and have now surpassed 1,000 systems globally.

Further, we continue to evolve our Hugo system with the fourth-generation software release and continuous system improvements. We are planning to expand into additional indications in the U.S. like hernia, part of our broader general surgery indication where this system really shines. Customers value. I mean they really value having a partner that spans the full continuum of surgical care. And Medtronic is the only company that has approved offerings across open, laparoscopic and robotic-assisted surgeries, which matters as hospitals build and expand their surgical practices.

Now we are thrilled with these 4 generational growth drivers, but our innovation pipeline is far broader. And we are committed to driving sustained innovation across our portfolio and advancing a steady cadence of new technologies across high need, high-growth categories, where we are well positioned, like MMA, carotid stenting, thrombectomy, coronary DCB, cardiac rhythm management, spine surgery as well as many others.

And to that point, I am extremely excited to highlight a major milestone in our Neuroscience business. Just last week, we secured FDA clearance for our Stealth AXiS surgical system for spinal procedures. Stealth AXiS is a new transformative platform that unifies AI-powered planning, robotics and navigation into 1 seamless system, elevated by the entire able ecosystem. Stealth AXiS was designed around navigation, which is paramount to surgeons workflow in the OR. Today, navigation, which we pioneered and we lead, drives 70% of U.S. spine procedures. And really, it just dictates the workflow in the spine OR. So Stealth is really 2 things. It's about taking share as a new platform with improved functionality, and it brings down barriers for physicians to step into robotics without disrupting their workflow.

Now building on our 10,000 unit installed base, we are expanding and opening this segment and extending our leadership, and we're not stopping at spine. We anticipate pursuing future cranial and ENT indications for Stealth AXiS. This is an important driver for our CST business and an exciting step forward to improve precision, predictability and personalization of care.

And we're executing our M&A strategy as well with the Cat Works acquisition and CRDN, and we continue to build out our venture and minority investment portfolio with the Enteris investment in structural heart. Both transactions underscore our long-term strategy to digitize, enable and build effective and efficient ecosystems within our core markets.

So before I turn it over to Thierry to walk through the details of our business performance, our financials and the guidance, I would like to close with the following remarks. At Medtronic, we are translating the breadth and the depth of innovation across the portfolio into durable growth. We have businesses at different stages of their growth journey, but the cadence of innovation across our portfolio suggests a steadily improving growth outlook for total Medtronic. We have businesses that are executing exceptionally well today and are positioned to be meaningful contributors for a very long time. This includes CAS its strong PFA pipeline, CST with Stealth my, and of course, CRM, a large and steady growth engine with meaningful innovation in defibrillation, in leadless and in conduction system pacing. We have businesses where the pipeline is now just activating, where we have clear line of sight to meaningful tangible opportunities that will enhance growth from CRDN with the ramp of Simplicity, pelvic health with Altaviva, peripheral vascular health with NeuroGuard and Libero and neurovascular with innovation like Artis, Neurogard and expanding indication for Onex into MMAE, and surgical, where the launch of Hugo in the U.S. is just beginning. These are all real drivers with tangible reasons for improvement and the potential to impact growth in the coming quarters and years.

We also have areas where there is work to do, and we have defined plans underway like in structural heart, where we're taking specific actions to fill out the portfolio and improve the trajectory. So with strong contributors delivering today, business is on the cusp of step change improvement and segments where we're taking deliberate actions to strengthen long-term competitiveness, we are confident in our ability to deliver durably.

So with that, I'll turn it over to Thierry to walk through the details of our business performance. So over to you, Thierry.

Thanks, Geoff, and hi, everyone. I appreciate all of you joining today. Let's start with our Cardiovascular portfolio, where this quarter, we delivered 11% year-over-year revenue growth, with 13% growth in the U.S. This represents the strongest growth we've seen in cardiovascular in the last 10 years, excluding COVID comps.

CAS grew 80% year-over-year, with PFA accounting for 80% of that revenue. Beyond CAS, the remainder of the cardiovascular portfolio delivered combined mid-single-digit growth.

Cardiac Rhythm Management also had a strong quarter. CRM continued to contribute 15% of our total revenue, and it grew a healthy 5%. This was primarily driven by continued double-digit growth in Micra, mid-teens growth in 3830 CSP lead and over 70% growth in Aurora EV ICD. In peripheral vascular health, we posted high single-digit growth driven by broad strength across our endovenous portfolio. We look forward to the continued launch of NeuUrOGARD-IAP carotid stent and the full market release of our Librac mechanical thrombectomy system.

In structural heart, Q3 was a little softer as expected and grew low single digits. We had a stronger quarter internationally and continue to gain share in Europe. This was partially offset in the U.S. where we annualized our Evolut FX Plus launch and saw some competitive pressure.

I'll now pivot to our Neuroscience portfolio, which grew 3%. Growth was a little below our expectations this quarter, but Neuroscience is also where we have 1 of our broadest pipelines and some of our most exciting opportunities. Importantly, we expect that pipeline to begin impacting growth in the fourth quarter.

Cranial and Spinal Technologies continues to be a powerful engine for Medtronic. This large business delivered mid-single-digit growth, including 8% growth from strong pull-through in core spine. We're excited to offer customers our new navigation and robotics platform, Stealth AXiS, which Geoff just mentioned. With FDA clearance achieved, we expect to see Stealth AXiS contribute Neurosurgery and CST overall as soon as the fourth quarter.

Specialty Therapies delivered flat results in the third quarter. This is an area where we expect improved performance in the coming quarters given the series of new product developments. Neurovascular has been challenged over the last quarters due to China VBP and to the recall of Vantage, both of which are now mostly behind us. We also have line of sight to a higher level of growth from the contribution of Onex's expanded indication. The NeuroGuard carotid stent launch will also contribute as it's being commercialized by both our Neurovascular and Peripheral Vascular businesses.

In Pelvic Health, we saw a slightly softer sacral nerve stimulation market environment, but look forward to seeing the increased contribution from Altaviva.

In Neuromodulation, we grew 4%, driven by the continued rollout of our differentiated, fully closed-loop technologies, in septive SCS and brain sends ADS.

Next, our Med Search portfolio grew 3% ahead of expectations. First, endoscopy and ACM had strong quarters. Endoscopy revenue grew 10%, led by mid-teens growth in our esophageal portfolio, driven by Next Powder and strong market adoption of Endoflip 300.

Acute care and monitoring saw a 7% growth, led by strength in blood oxygen management and airway access. And finally, our Surgical business grew by 1%. We saw strength in energy and wound management and hernia with expected softness in stapling. The next phase of growth for this business is the rollout of Hugo, and we're thrilled to see our first installations and first cases so swiftly after the U.S. launch.

Wrapping up our business performance is MiniMed, our diabetes business, which delivered 15% reported and over 8% organic growth. Performance was led by double-digit strength in international markets, but we also saw acceleration in the U.S. with strong sequential lift driven by Simplera Sync and Instinct, which both just launched in December. Our Diabetes business continues its strong innovation cycle, supported by multiple recent regulatory and pipeline milestones.

In addition to introducing Instinct and Simplera to the market, we secured several FDA clearances that further expands 780G's indications. We also announced that 780G system is now available through pharmacy with agreements that cover the majority of commercially insured lives in the U.S. And we submitted MiniMed Flex to the U.S. FDA and began the U.S. pivotal study for Vivera, our third-generation fully closed loop algorithm, which we believe will help maintain our leadership in delivering industry-leading outcomes. Finally, our MiniMed Fit patch pump remains on track, and we intend to submit it to the U.S. FDA by this fall. The planned separation of MiniMed is perfectly on track. Our preferred path continues to be a 2-step, IPO and split. We continue to expect the separation to be complete by the end of calendar year '26.

Now turning to the financials. This quarter, revenue of $9 billion grew 8.7% reported and 6% organic, a 50-basis-point acceleration from prior quarter and 50 basis points above our guidance. Geographically, this performance was balanced, led by high single-digit growth in Western Europe, with mid-single-digit growth across the U.S. and Japan. U.S. growth was 6% year-over-year, the strongest performance we've delivered since fiscal year 2019, excluding COVID compns.

In China, we delivered low single-digit growth while navigating ongoing but manageable volume-based procurement in a few businesses. Excluding DBP, our growth rate in China was mid-single digit.

Our adjusted gross margin was 64.9%, ahead of expectations. As I've done in the last several quarters, let me walk you through the rough breakout of the components. We realized 30 basis points of benefit from pricing. Net of inflation, cost down was negative 20 basis points as the third quarter is typically our lowest quarter for generating cost efficiency savings, and we had some prior year nonrecurring items. Mix was negative 100 basis points, mostly driven by CAS and Diabetes. As discussed in prior disclosures, with CAS in the early stages of launch, this business is currently impacted by the mix of lower margin capital to higher-margin catheters, and Diabetes is in the -- in its early manufacturing ramp-up of Simplera.

Over time, as you know, we expect this mix dynamic to improve as we scale CAS and separate the diabetes business.

Tariffs impacted the business $93 million or 110 basis points, in line with forecast. And finally, foreign exchange provided an approximate 40 basis points tailwind.

Adjusted R&D was 8% of revenue and increased 7.4%. On an organic basis, this outpaced revenue by 50 basis points. Our adjusted SG&A was 32.3% of revenue, which is 30 basis points lower than the third quarter of last year. We continue to fuel our PFA launch and develop and build the markets for Simplicity, Altaviva and HUGO, but at the same time, we delivered disciplined leverage in G&A.

Our adjusted operating profit was $2.2 billion, resulting in an adjusted operating margin of 24.1% ahead of expectations again.

Our adjusted tax rate was 17.3%, about 100 basis points higher than forecast, largely due to jurisdictional mix of profits.

All in all, adjusted EPS was $1.36, and $0.03 above the midpoint of our guidance range.

Now turning to guidance. On the top line, we're reiterating fiscal '26 organic revenue growth guidance of approximately 5.5%. In the fourth quarter, we expect revenue growth similar to Q3, so around 6% off a stronger Q4 '25 comp.

Moving down the P&L, we expect our fiscal '26 gross margin to increase slightly ex tariffs. Pricing, FX and COGS efficiency programs are expected to more than offset the negative impacts of business mix, primarily from CAS and Diabetes. We anticipate a tariff impact to COGS of approximately $185 million, including $75 million in the fourth quarter.

Including tariffs, we expect fiscal 2016 gross margin decrease of roughly 30 basis points. We expect fiscal '26 adjusted operating profit to grow approximately 5% or 7% excluding tariffs. Our fiscal 2016 operating margin is expected to be roughly flat, excluding tariffs, and down about 50 basis points, including the tariff impact.

In totality, we expect these results to deliver gross margin and operating margin leverage ex tariffs in the second half of the fiscal year '26 as we stated last quarter.

Turning to EPS. This quarter, we saw a beat of $0.03. This was largely due to a slightly better-than-expected revenue in the quarter, mainly from CRM and ACM. This was partially offset by the aforementioned tax pressure that we saw in the quarter. As we expect CRM and ACM to normalize and the tax pressure to carry into Q4, we are maintaining our fiscal '26 EPS guidance in the range of $5.62 to $5.66.

Look, we're excited about the quarter, and we think Q4 is going to be another robust quarter and that we will sustain our growth at a high level and into the next year. We're making progress on margin expansion, and the negative mix effect from CAS and Diabetes are going to get better. We're going to continue to invest in growth areas like R&D, sales and marketing and M&A to capitalize on the opportunities ahead of us. And we will also continue to drive efficiency in functional areas.

All told, we are committed to our guidance, and we maintain our expectation for high single-digit EPS growth in fiscal year '27.

Back to you, Geoff.

Okay. Thanks, Thierry. Now before we go to Q&A, let me close with a few final thoughts. So we're encouraged by the progress across the business, as Thierry just said, and we remain committed to stronger, durable revenue and earnings growth. Our PFA trajectory is strong, and we're progressing on multiple billion-dollar opportunities. We're reinforcing our future pipeline, and we're committed to organic and inorganic investment to further bolster the portfolio. Bottom line, we are delivering.

Now to our Medtronic colleagues around the world, thank you for your unwavering commitment to our mission and to the patients we serve. You are delivering for customers and for patients, and you're turning our strategy into performance. So thank you.

With that, let's turn to Q&A. So first, Ingrid, welcome to your first earnings call. And now can you please provide the instructions and queue up the analysts.

[Operator Instructions] We'll take our first question from Travis Steed at Bank of America.

First, I'll start on just the comments on accelerating revenue growth next year and growing earnings, high single digits. When you think about CAS obviously -- can you hear me okay? Can you hear me okay?

There we go.

Yes.

Okay. I just wanted to ask about the accelerating revenue growth for next year and also the the commitment to grow earnings in high single digits. I guess when you think about the overall portfolio, obviously, CAS is starting to hit tougher comps and this quarter, surgical is only growing 1%. So just trying to think about how you get that business accelerating with Hugo and just like the commitment to be able to deliver on the commitments that you've kind of laid out for FY '27?

Well, thanks, Travis, for the question. I'll give it a start and then hand it over to Thierry. I mean, look, on the top line, obviously, as you mentioned, we had a really strong quarter with CAS. We still -- we think that growth is going to continue and become a larger part of the company, obviously. We're well positioned there. And then we -- our other big growth drivers, particularly Simplicity for hypertension and Altaviva for overactive bladder, we see them beginning to kick in here even in Q4. And then you've got a number of other businesses here that are going to start growing faster than they have been here recently. One is CST with the Stealth AXiS. I'm sure we'll get some questions on that. But I do think this is kind of underappreciated, quite frankly, by the Street. This is not just a new robot. It's not just an extension of [indiscernible], it's a whole new platform that has a lot of benefits to it, and I think that's going to create growth for the short and long term for CST.

And then Neurovascular is going to kick up as well. Neurovascular has got a number of new products like the Onyx indication for MMAE as well as our carotid stenting product NeuroGuard. And then it's anniversaries, BBP and a few other things. So you're going to see a kickup in neurovascular as well. So I think we feel good about the growth continuing here out not just in Q4, but into FY '27.

Yes. And on the EPS side, so as I mentioned in the comments, the algorithm is clear, right? So we have the accelerated growth. The things are getting better at the gross margin level, in particular, in the second half, as we'll see the mix effect from CAS getting better and the separation of Diabetes. We'll continue to drive the leverage on the functional areas, in particular, in G&A. And we'll then continue to invest in R&D and in M&A. So we're reiterating the high single-digit EPS growth guidance for '27.

We do have a couple of meaningful puts and takes in the number next year. And as we're getting more visibility, we'll keep you posted on what the impacts are. But to name a few, so we'll have the carryover from the tariffs settlement going into next year. This year, we had about 2.5 quarters of tariffs, and that will carry over into the full year. I think the way to think about that is about $75 million per quarter. So on a full year basis, it means around $300 million of our headwind versus the $185 million we had in -- what we're having in '26.

We'll have a little bit of help from the fact that there's 53 weeks in fiscal year '27 as opposed to 52 usually. And then the Diabetes deal, we fully expect the deal to be accretive. But between the moment we do the IPO and the moment we do the split, you should expect some dilution to the tune of $0.01 to $0.02 per month. The reason behind that is that most of the stock -- the Medtronic stock retirement that we will do that drives the accretion happens only upon the separation. And so we'll see the accretion later. But initially, we've got a little bit of pressure coming from that.

And we've also embedded in the guidance $0.04 to $0.05 of dilution coming from M&A activity. So we've already announced Cath Works and Antares. And so we've embedded that in the guidance. So it's all in as we get more visibility to the timing of Diabetes and the closing of the M&A deals, we'll give you more specifics on the different impacts in the Q4 release. But as you can see, we're committed to the growth acceleration. We're committed to the investment with M&A and with R&D, and we're committed to the guidance.

Yes. And just on [indiscernible] acceleration. Go ahead, Travis.

There's an extra selling week next year. Is that -- is the growth acceleration excluding the extra selling day?

So that will be part of it. That will be part of it. And again, we'll give you the details of the impact as we go into the Q4 announcement.

When I think about the growth acceleration, you mentioned cash in Q3. I mean beyond cash, you saw our CRM business and our Peripheral Vascular Health business, both step up in Q4, like I said and beyond, CS -- think about CST and neurovascular starting to accelerate. And then as you get into FY '27, that's when the Ardian and Altaviva really kick in and also Hugo. So we feel good about that acceleration.

Our next question comes from Vijay Kumar at Evercore Vijay.

Geoff, congrats on a nice spin. I had 1 product question and 1 clarification on the guidance. On the product, you mentioned already in [indiscernible] and Altaviva, those will be growth accelerators in fiscal '26. How should we monitor the progress? Are there any goalposts that we can look forward to in tracking the launch curves for RDN and Altaviva?

It's a good question. I think we'll start to lay out more concrete goal posts as we go forward. Right now, we've been talking a lot about the leading indicators that we're seeing with both, and we're seeing really strong leading indicators like with Altaviva, we talked about training 500-plus physicians. You have strong demand, training 500-plus physicians. And like I said last quarter, I mean, these are -- this is over the weekend often traveling. It just shows the commitment here.

And then things like in renal denervation, I'd say it's things like the opening of new accounts. Like this quarter, we opened 200 -- over 200 new accounts, our physician finders up to 150 physicians. And remember, that's a low -- it's a high bar to get in. You have to do 5 cases and plus opt-in. So there's a lot more physicians doing cases today. And we'll continue to track like the covered lives, like for Ardian. We're already up to like 100 million covered lives. It's about 1/3 of the population here in the U.S. So those are all leading indicators, and we'll start putting more other, as you put, goalpost out there as this starts to mature a little bit, both of these launches. I don't know if you have anything to add to that, Thierry?

No.

Great. And just 1 clarification on the extra week Geoff, we're looking at exit rates of 6% organic, right? And let's assume next year is north of 6%. The extra week is almost 2 points of growth. So are we looking at base organic excluding extra week somewhere in the 5%-ish range or any thoughts on how to think about extra week contribution?

So maybe I'll take that one, and thanks for the question. Look, first, it's a little bit less than 2 points of full growth. And again, we'll give you the specific calculations as we close the year, but the way to think of it is that there's going to be growth acceleration, excluding the extra week, right? So it should be upside. So we should have better growth than we have in fiscal year '26, in '27 and the extra week should be on top of that.

that clear, Vijay?

Crystal clear, yes.

And our next question comes from Larry Biegelsen at Wells Fargo.

Geoff, I wanted to ask about cash and your growth continued to accelerate this quarter to 80% worldwide, which implies the worldwide EP market grew about 20% in calendar year Q4. So my question is, how are you thinking about the EP market growth in calendar year '26, and your CAS growth going forward now that you're lapping the Affera U.S. launch? I think to achieve the trailing 12-month $2 billion goal, it looks like your CAS growth has to kind of sustain about 80% in the next 2 quarters. Is that directionally accurate?

Well, first, I'd say you're -- we agree with you on the market growth in our fiscal Q3 or Q4 here of around 20%. And we think the market will continue to be like that in the near term. And for our fiscal '27, we think it's going to be at least high teens and thereafter, a strong double-digit market. So we see the market growth continuing, and then we believe we're really well positioned with our portfolio of catheters that we have as well as mapping.

In terms of our business growth, we do see it sustaining here in Q4, and we haven't provided guidance beyond that. But again, I'd like to say, I think we're very well positioned here. When you look at the 4 players in PFA, I think we got 2 that are really, their value proposition right now is setting around mapping. And we feel like we're very well positioned against them because we still think the catheter carries the day, and we have integrated mapping. And then when you look at our competitor that's really their value proposition centers around catheters, we believe we have a better portfolio of catheters.

Our Sphere-9 has, like I said in the commentary, proven to be quite versatile. And I know initially, our competitor here did a pretty good job of putting out a narrative that Sphere-9 was more of a niche. And I think as that's gotten out there, that's proven not to be true as it's being used in across persistent and paroxysmal. It's new cases, redos. It's simple versus complex. It's being used across the board. And then we've got SER-360 got CE marked and it's a single shot catheter. And again, that's probably the one catheter that's got more excitement than Sphere-9, and we started the U.S. trial. And then, of course, we're going to have mapping upgrades on a regular basis.

So feeling pretty good about our position today as well as tomorrow. And like I said, the underlying markets were really strong.

Our next question comes from Patrick Wood at Morgan Stanley.

I'll keep it to one, just given there's so much going on. Obviously, the [indiscernible] deals. I know you were close to [indiscernible] for a long time. How are we thinking about capital allocation and M&A? There's a lot of other companies doing very large deals in the space. I'm just trying to work out directionally, do you guys feel still more that it's kind of bolt-on M&A, technology tuck-ins, that kind of things relative to larger deals? And how are you thinking about capital allocation going forward?

Well, thanks for the question, Patrick. And like as we've stated, we're very committed to accelerating M&A, and you're starting to see that with Cathworks and [indiscernible]. And again, it's very focused tied to our strategy venture investments that might lead to -- ultimately to M&A and then M&A. And we are focused on more like what we would define as tuck-in deals. They can get up to several billion dollars. But tuck-in, in or a close adjacency to our existing business and a number of them though. I mean that's the other thing. I think it's a fairly meaningful amount of capital among several different tuck-in venture and tuck-in opportunities across our portfolio. Again, prioritizing maybe the higher growth areas, and in some cases, maybe having multiple shots on goal, like we did with [indiscernible] ablation, right? We've done an organic program. We went out and got Affera. We may see us do that again in some of these high-growth really must-win markets where, but that's how I would say, a tuck-in across many of our different segments and subsegments as well as venture.

So Robbie Marcus from JP Morgan will be our next question.

Great. Can you hear me okay?

Yes.

Yes.

Great. Two for me. Maybe I'll ask them just as one. Jeff or maybe Thierry. As you think about the fiscal '27 guidance and especially, I imagine you'll have you go in renal denervation and tibial spend to support those launches and continued investment in CAS, how do you think about getting to the high single-digit EPS growth? If you could give us some high-level drivers there?

And then second part, the Street is sitting at 8.5% EPS growth. I know traditionally, you do something like 6.5% to 9.4% as high single. Do you think the Street at 8.5%, is that a good midpoint of the range to start here?

Robbie, thanks for the question. So again, on EPS, the high-level drivers. We talked about the accelerated growth. And obviously, that's going to help from a leverage standpoint. If you look at the gross margin line, what you've seen so far is operational improvements in pricing and cost out that have been offset by the mix effects on CAS and Diabetes, and as I've stated a couple of times already, those are going to get better. So the CAS improvement comes from the mix shifting towards more catheters and less capital equipment, which will help from a margin perspective. And then on the Diabetes side, it comes from the separation, right? So Diabetes has a lower gross margin rate than the rest of the business. And so once that business go away, it will give us a natural lift from a gross margin perspective.

If you start looking at overhead, look, we're going to continue to lean into R&D and sales and marketing to develop the franchises that you mentioned. So we're putting resources in Ardian. We're putting resources in CAS. We're hiring the mappers that are necessary. We're doing the direct-to-consumer marketing on -- in particular, on renal denervation and Altaviva. And we'll continue to do that. But net-net, the SG&A line will provide leverage because we -- as we're having this quarter, for example, Q3, what you see is the leverage that we get on the G&A line more than offsets the resources that we're putting from our sales and marketing perspective. So look, that will provide some improvement on operating margin. And then below the line, we'll continue to have a little bit of a headwind on the interest line because we're refinancing debt that was contracted almost at 0% 4 or 5 years ago with debt that's now sort of 3.5%, 4%. And we'll continue to have some pressure on tax. But the tax line is kind of getting to where it's going to stabilize now.

And then look, I mentioned we have a few puts and takes where we need to understand the timing between now and your ends. One is the timing of the Diabetes separation. And as I said, between the IPO and the split, we get about $0.01 to $0.02 of dilution from the fact that we're losing 20% of the profit of diabetes, but we don't have the benefit from the share count reduction yet. That share count reduction is calculated on a 12-month rolling average. So you'll see that gradually get better. And then we'll have some dilution coming from M&A. So the guidance is all in at high single-digit EPS growth.

Now the second part of your question on the 8.5%, it feels like some of the latter items that I mentioned, so the sort of temporary dilution that we get from Diabetes and and some of the M&A dilution that is maybe not fully embedded in what the Street sees right now. And as we get more visibility, we'll help clarify that.

Our next question comes from Matt Taylor at Jefferies.

I wanted to follow up on the question around capital allocation in TAVR. I guess it was interesting to see the investment in tariffs. I was wondering if you could comment about why you didn't just buy the whole company versus invest? And we also saw over the weekend, the results a longer-term follow-up for CoreValve published in JAK. And similar to the Edwards trials, there was some late catch-up in mortality. I was wondering if you could comment on that in the TAVR arm?

Sure. I think on your first call on [indiscernible], I mean, it's just -- we feel the structural heart space is one of the spaces we help pioneer. We have a really strong position, great reputation, but we want to expand in that. We've got some organic program. Obviously, we have our Evolut platform. We've got mitral and tricuspid replacement programs, but we still think there's an opportunity here to expand. And in the case of TAVR, the balloon expandable is the larger piece of the market and this is an opportunity to get into that market. And again, we may have multiple shots on goal here. But I think [indiscernible] is a good one to invest in and partner with, and we'll see where we go from here there.

And then in terms of the JAK article, I would say here that, look, this is -- I just want to emphasize that this is an old valve that's no longer commercially available, and it's an old procedural technique that we've provided guidance. So basically, all that communication did is reiterate the guidance that we provided back in 2020. And so that's what's happening there. And like I said, we're collaborating with our physicians to make sure they understand all of this and moving forward from here. So that's -- I don't know if you have anything to add there, but bullish on the structural heart space, and I would -- the [indiscernible] investment and who knows maybe more following that.

Our next question comes from Matt Miksic from Barclays.

Great. And congrats on the Antares investment, by the way. So on cash, I'll just ask 1 question. You mentioned generator sales or kind of a headwind to gross margins at this point, the mix is maybe shifting a little more towards capital you can give us a sense of when that starts to normalize? And then also in terms of the runway, I think we understand that hiring mappers is maybe the bottleneck here if there if you want to put it that way. You need more people to open more centers to get more catheter use. Any sense of where you are in that continuum through the academic centers or into the general centers in the U.S. and some sense of the pace that you're able to maintain for hiring centers? So helpful color.

Thanks, Matt. On the last part of it, where are we? I still think we're kind of relatively early in our launch here where we still have a long runway to go, which is good, in penetrating some of these high-volume academic centers as well as getting out beyond that. And to your point, the mappers -- hiring mappers has been critical. It's not the topic, if you will, but it is an important topic here. We've been able to stay ahead of it, but it is the thing that we're probably the most focused on right now is continuing to hire mappers.

And a lot of these mappers tend to be pretty dedicated to the space, and they're seeing where the direction of travel is or to use the Minnesota term where the puck is going. And so that helps a lot as well. So that's how I would comment on there. And what was the first part of the question?

The first part was on the dilution that comes from the capital equipment and when does the mix turnaround? So first what I want to say is CAS is a fantastic business from an operating margin perspective, right? So it is slightly dilutive because of this mix issue at the GM level, but it's driving significant profitability at the total business level at the operating margin level. When it's going to turn around between capital equipment and catheters, I want to say it's almost a good problem to have. So I hope it turns around as late as possible because as we're building the installed base, it's always going to be good news going forward. That being said, I think you'll start to see an inflection in the second half of next year. The mix is starting to improve with the catheter sales increasing. And look, year-over-year, CAS is going to drive gross margin improvement as early as '27.

So look, it's a great business to be in, and it's all good news going forward.

Our next question comes from Chris Pasquale at Nephron.

I wanted to ask about Hugo. Geoff, you talked about the impact of Simplicity and Altaviva really beginning to kick in as soon as next quarter. I don't think you included Huge in that group. So I would love to hear how you're thinking about the time line for Hugo to really begin to move the needle within the surgical business? And any qualitative comments you can make about the system pipeline right now?

Well, first of all, look, super excited about where we are with Hugo. Big quarter for us this past quarter, getting the FDA approval. We just announced this morning we did -- we completed our first cases in the U.S. in February earlier this month in Cleveland Clinic. We got more scheduled this week, got other centers and all the leading indicators of Hugo. And by the way, on those cases, we got great feedback in terms of how the system is performing and and its future opportunity in the U.S. market. The leading indicators are all positive in terms of the smooth case rate, procedure growth globally and utilization, they can both continue to be really strong. We watch those every week. I know the business watches it every day, I see them every week. And we're seeing a pretty meaningful step-up in installations around the world, especially as U.S. kicks in.

And so look, we expect a step up in Q4. Now the surgical business is a big business, has some puts and takes. So you may not move the needle on the surgical business quite yet. But underneath the covers there, Hugo is growing and growing pretty fast now. And it will -- eventually, you'll see -- you'll start to see this move that big $6 billion business. But we like where we sit. Really excited about getting into the U.S. market and the reception that we're getting and the orders that we have.

Next question comes from Danielle Antalffy at UBS.

Geoff, I was hoping you could talk a little bit more about how we should think about renal denervation, Simplicity and the market development that you're talking about? We've talked to some referring physicians who've been involved in renal denervation since the very beginning, and she sounds like she's getting a lot of calls from folks. I'm just curious what goes into actually developing this market, building out -- helping centers build out referral networks, et cetera. And if you any color on actual numbers to date even directionally?

Sure. Thanks, Danielle. I mean, I appreciate that question. I mean, first of all, in terms of physicians getting a lot of calls, that is really starting to kick in. Just to give you -- again, I appreciate that it's a leading indicator, but it's pretty powerful. So on our direct-to-consumer website around Simplicity, I'm just double checking, last quarter, we had maybe 50,000 -- or Q2 rather, we had about 50,000 visits. In Q3, we had 2.5 million visits. So the consumer demand is really spiking here, and we're just getting started. Like I said earlier, we opened up over 200 accounts, the Physician Finder is up, reimbursement is strong, we're getting that strong consumer demand. And most importantly, we're getting terrific patient results, patient outcomes, right, with the blood pressure coming down meaningfully. It's staying patients -- and it's really resonating with patients, and that in and of itself is getting doctors excited.

And so what we're doing is we've been hiring a lot of people in terms of market development. And there are several different roles here, right? One is building that referral pathway from the general practitioners in the hypertensive specialists into the hospital, into that procedure list. We've got a lot of people around health economics, around coding and billing as well helping the hospitals. So it's a number of roles like that, right? Health economics, coding, billing as well as some of the other roles I said in terms of the market development, building those referral pathways. And that's really where things are right now.

I'd say, all the market, like the initial foundational elements have all been like the chips have turned over green, right? The FDA approval is breakthrough approval, and it's broad. The CMS reimbursement, it's a good number and it's broad. We -- the commercial payers are falling in line and the competitive dynamics are way better than we thought. We -- initially here, we're doing -- I saw different analysts' over the last couple of years predictions on the mix between us and the other competitor on the market. We're doing way better than any of those models. And so now we just got to build this market. It's all those things we said, Danielle. But again, where we're really excited where you feel the energy is it all starts with those patient outcomes and how this is resonating with consumers.

So the other thing we're going to do over time besides building the referral pathway, working with hospitals is building the brand around Simplicity, right? So all of the 50,000 to 2.5 million I talked about of site visits, that's all about lead development, lead generation. We'd also like to build the brand of Simplicity and make it synonymous with hypertension management. So that's going to be an investment that Thierry talked about for FY '27. So a lot of exciting -- a lot of excitement right now in Ardian. And It'll start to -- the numbers will be more meaningful in FY '27 for us, the actual revenue, the lagging indicators. And again, it will be -- it's very profitable right out of the gate for us.

And as we reach the top of the hour here, our last question is going to come from Joanne Wuensch from Citi.

And before we move to Joanne, please, of course, e-mail us for any of those we did not reach today. Sorry, and thank you, and we'll look forward to talking to you soon.

I'm going to ask the Stealth AXiS question and what you can share with us about the product and why you're so excited about it?

Well, thanks, Joanne, for that question. I -- first of all, like I said, I do think this is -- has been -- is meaningfully underappreciated in the not so much maybe in the clinical community from spine surgeons, but maybe in the investment community because, look, this robot does 2 things. First of all, it's not an extension of Mazor. It's a new platform with a ton of new functionality that's going to be very value added. But the other thing that's really important here is how it fits into the workflow. So today, 70% -- I mentioned the commentary, 70% of procedures in the U.S. are navigated. That's like navigation and arm, which we invented and we lead by far. And today, robotics doesn't work well with that that workflow. So that's why robotic penetration is a lot smaller than the 70% that we're seeing with navigation. The Stealth AXiS fits right into that workflow. So it's one seamless system from the initial imaging to the AI-based surgical planning, right into the case, navigation, imaging and now robotics, 1 seamless workflow that trust me, surgeons really have been waiting for. So you got a better robot with more functionality and then you've got a much, much, much better workflow that, as you know, is super important to physicians and health systems. And this is just effectively lowering the barriers to step into robotics for spine surgery, and it's going to grow the market, I believe, and we are definitely going to continue to take share. And this really lengthens or extends our lead, in my opinion, from our primary competitor in this space.

The competitive dynamics have dramatically changed over the last couple of years. We're enabling technology and our AiBLE suite is key to winning. And this is, like I said, extends our lead over our competitor. And so super excited about that, but in closing here, I'd say beyond some of the big generational growth drivers we mentioned, we talked a lot about CAS and Ardian in a little bit about Altaviva and Hugo, I would add to that robotics piece, I would add Stealth AXiS. But we've got a breadth of innovation right now in Medtronic, which is why you -- we are getting the excitement here. Whether you saw from this quarter, like I mentioned from CRM and peripheral vascular health, which we didn't get any questions on, their growth has meaningfully improved here from a number of new products like carotid and thrombectomy. We talked about CST accelerating, neurovascular is accelerating with new products, that they've got between the NeuroGuard carotic product as well as MMAE, it's a mouthful. And then you've got these -- like I said, these bigger growth drivers like Ardian and Altaviva that are at the very, very -- and Hugo that are at the very early stages.

So you're starting to see the breadth kick in, which is beautiful to see. I know that in this business, innovation is key. And we've got a depth of innovation with these big generational growth drivers, but we also have the breadth. And as Thierry walked through, I think it was Robbie's question, we're pulling different levers to make sure that we're investing appropriately in these organically, whether it's increasing R&D, funding direct-to-consumer, hiring a ton of mappers, and if you're a mapper out there, hit our website up, and then kicking in the M&A, right?

So we're really shifting our stance, moving into more of an offensive footing here, and it's based on just the momentum that we have and the momentum we see coming.

All right. Thank you, everyone, and I'll turn to Geoff for some closing remarks.

I thought that was the close. Okay. Thank you. Thank you all for joining today, and all of your questions, and appreciate your support and continued interest in Medtronic. And we hope that you'll join us for our Q4 and our full year fiscal '26 earnings broadcast, where we're going to update you on the continued progress that we just talked about against our short- and long-term strategies. With that, have a great rest of your day. Thank you.

Welcome, everyone. I'm Robbie Marcus, the MedTech Analyst at JPMorgan. Very happy to introduce our next session. We'll have Geoff Martha, Chairman and CEO of Medtronic, present, and then we'll be joined up on stage for some Q&A. Geoff?

All right. Thanks, Robbie. All right. Good morning, everybody, and thank you for joining us today. Before I begin, I would like to remind you that today's discussion will include forward-looking statements that are subject to risks and uncertainties, and so we encourage you to please reference our SEC disclosures. Well, I'll start with saying, look, it's an exciting time for Medtronic. For the last several years, we've been working diligently towards this moment through engineering rigor, manufacturing expertise and regulatory know-how. And now we're in the fortuitous position to accelerate our revenue growth and our earnings growth. Today, we're going to talk about 4 key areas: accelerating on both what we call our generational growth drivers like PFA, Symplicity, Altaviva, Hugo and through our continuous pipeline of new technologies in areas like thrombectomy, carotid, spinal navigation and robotics, MMAe or in our case, Onyx, and many more.

And we're focused and hyper-focused on expanding margins, which will help us drive increased R&D to fuel the future growth as well as our EPS leverage. And finally, we're executing on strategic portfolio management and capital allocation. But let's first take a step back, and I'd like to remind everybody of Medtronic's key businesses today. Medtronic is an innovation-driven global MedTech leader, and our focus is on high-growth, high-margin opportunities to improve patient lives. We have a diversified portfolio in cardiovascular, neuroscience and Medical Surgical. And you also see our nearly $3 billion revenue diabetes business on the page here, which, as announced last May, we intend to separate by the end of the calendar year via an IPO. So in total, our 3 focus areas represent a $100 billion market opportunity, and we are well positioned to get -- to execute within these critical areas.

Now this slide has an important message I want to make sure we bring home. Over the last several years, we've been putting the people, the processes and the tools in place to form what we call the Medtronic Performance System. It's changed the way we execute, enabling us to deliver on our promises commercially, operationally and, of course, financially. We've addressed things that have historically held us back -- held our performance back. We've transformed our quality function to yield even greater safety outcomes. We've optimized global operations and supply chain, for example, consistently achieving now 5% gross COGS improvement, and our back order levels are at all-time lows. We've built the foundation to make all of this sustainable as well, and you'll see this start to flow through in the coming quarters. And we've made the hard yet purposeful decisions around portfolio management to drive even greater focus within the organization. And today, as we sit here today, we are focused on growth and innovation.

In the last 12 months, we've unlocked 4 new multibillion-dollar opportunities while accelerating our revenue growth. We're on track to deliver well above $2 billion in revenue for CAS in fiscal year '27, which we'll talk about a little bit later here. And to follow, we have a strong pipeline across the enterprise. And with the top line coming into place, we're now relentlessly pursuing margin expansion. You put all this together, we're driving greater effectiveness across the entire organization to fully realize the benefits of these big new opportunities. All right. The clicker is not working. That doesn't work either. Can I just push the button here maybe, go the old-fashioned way? No, that's not working either. Just going to use this now. Okay. All right. Great. All right. So getting back in the groove here. So we're delivering -- this slide, so now we're in a position to execute on these 4 areas.

So we'll discuss the details of each of these 4 areas in a moment, but all of these are devices that are approved in the early innings of launch and each represent a $1 billion-plus revenue opportunity for the company. And this is going to fuel our growth for years to come, and these are core markets for Medtronic. So like I said, it's a pivotal time for the company, and our teams have anticipated this moment for years, and we're well positioned to execute. Now I'm going to dive deeper into each one of these unique opportunities. We're going to start with electrophysiology and specifically atrial fibrillation, which remains one of the highest growth areas in med tech. Our Cardiac Ablation Solutions business, or CAS, as we call it, represents over a $13 billion market opportunity, growing annually at 25%. We are winning share here in this fast-growing space with our comprehensive portfolio of PFA catheters. We started to see an acceleration of PFA revenue roughly 12 months ago.

And now we are on track to reach $2 billion of trailing revenue and total CAS revenue by the first half of fiscal '27. With the top 30% of the centers performing 70% of the total AF volumes, our teams are really focused on going deeper into these accounts to increase catheter utilization, roll out our next-gen software and add mappers for greater account coverage. So in this space, we have a versatile platform of catheters and will service multiple clinical needs in different geographies. So let's start with Sphere-9, which is our all-in-one really our workhorse catheter. It's a versatile first-of-its-kind dual-energy catheter with integrated mapping that delivers superior safety and durability. PulseSelect, which is our first PFA catheter, offers a leading safety profile and is a strong option for price-sensitive customers and those that lack access to general anesthesia.

So as we look ahead, we're going to continue to innovate and we're going to continue to expand. So adding to our international business, we're excited to bring Sphere-9 to Japan in the first half of calendar 2026. And we're pursuing expanded indication into VT in the first half of calendar '26 as well. And we're really excited about our next-gen single-shot Sphere-360 catheter. So the EU trial demonstrated strong durability, safety, speed and clinical efficacy, and it's a very highly anticipated solution by physicians. Our U.S. study was approved last month and will begin enrolling in the trial in the coming weeks. So this is only the beginning for us in PFA, and we look forward to continuing our market-leading growth rate as we march towards market leadership.

Let's switch to hypertension. So like PFA, renal denervation is a huge potential market. However, unlike PFA, Symplicity is a new market that we are pioneering and developing. Today, hypertension affects 1 in 2 adult Americans, but despite decades of access to numerous medications, hypertension continues to be a problem, causing 50% of heart disease and stroke-related deaths globally. Over 75% of hypertension patients do not have their blood pressure under control and 50% stop taking their medications in 1 year. And now here comes Symplicity. It's a onetime safe and durable treatment that has consistently demonstrated material blood pressure reductions. So as I just described, the unmet need is very clear. And with over 10 years of clinical data and over 30,000 patients treated globally, Symplicity is one of the most researched therapies in cardiovascular.

More than 18 million U.S. patients with uncontrolled hypertension are eligible for Symplicity and just a 1% penetration into this market represents yet another multibillion-dollar revenue opportunity for the company. So we're building therapy awareness with patients. We're training physicians, creating referral pathways and activating new sites every day. And looking ahead, we're also innovating. We're already working towards a trans-radial approach, which we plan to launch in the second half of FY '27. And we're investigating combined denervation of both renal and hepatic arteries for even greater efficacy. So beyond improving the current procedure and increasing efficacy, our plan is to make Symplicity synonymous, the Symplicity brand synonymous with the treatment of hypertension. So we're first to market. We've put in the investment. We've put in the work, we certainly put in the time. And now we plan to capture and lead this space for the long term.

Next up, Altaviva. Altaviva delivers neuromodulation via a small device positioned just above the tibial nerve, providing a simple same-day therapy activation for patients suffering from urge urinary incontinence or UUI. The Altaviva device has an expected 15-year battery life, is MRI-ready and does not require sedation or imaging. These are key attributes that make Altaviva differentiated solution for patients and for the providers. Today, here, there are 16 million patients in the U.S. alone suffering from UUI. So it's a big patient pool. 5 million of these individuals are eligible and actively seeking treatment. And again, roughly a 1% penetration of this 5 million patient pool represents another $1 billion revenue opportunity for the company. So here, education and awareness are the focus. We're seeing significant engagement and interest. Just 4 months post approval, over 500 physicians have been trained in just those 4 months.

And this is a meaningful commitment of their time because it's an in-person training, not virtual and often in a different city, in most cases, in a different city from where they practice, which shows their interest and just as a good leading indicator about the future potential of Altaviva. We're launching also a direct-to-consumer awareness to reach the 5 million patients I just spoke of as well as the balance of the 16 million who just aren't quite ready, aren't quite comfortable seeking care. This will come. The stigma is breaking down. Now let's shift to Hugo, robotic-assisted surgery. But before I jump into Hugo itself, I want to take a step back and talk about surgery. We have an incredible history in surgery with over 100 years in the OR as a category creator and leader in numerous product areas. We have earned the trust of generations of surgeons.

Further, we're the only company to offer solutions across all surgical modalities, open, laparoscopic and now robotic-assisted. Our broad capabilities position us to give our customers choice. And this does 2 things. First, it provides customers with the choice in robotics, a competitive choice in robotics that they've been waiting for practically begging for. Second, it enables customers to get back to their comfort zone, contracting with a true partner for their diverse surgical needs. So now let's get back to Hugo specifically. Last month, we announced FDA clearance for Hugo with the urology indication. We've learned -- outside the U.S., we've learned tremendously from our prior experience in over 35 countries and across 50 different procedure types. And we're thrilled to be launching Hugo in the U.S. and bring this experience with that.

We're getting a lot of good feedback from customers on Hugo's differentiation in 5 areas: modularity for arm range of motion and portability between ORs, open console for improved situational awareness, ergonomics and collaboration in the OR, trusted instrumentation from a surgical leader. Four, our touch surgery digital ecosystem. And this is a key one. It's unique to Medtronic. Digital is a force multiplier for robotics and laparoscopic surgery as it brings actionable data, analytics and AI into the OR. And finally, partnership, partnership across all modalities, open, lap and RAS, which is critical to customers as they build and expand their surgical practice. So our purposeful U.S. launch of Hugo is now underway, and we're ensuring successful first experience for our physicians and their teams. Our teams are also working diligently to expand into additional indications with hernia and gynecology and add advanced instrumentation like LigaSure.

Okay. So beyond those 4 generational growth drivers, as exciting as they are, we are delivering innovation across the balance of the portfolio as well. This slide here represents products that were approved and launched in the last 2 years alone. So products like Inceptiv for SCS or Percept for DBS, next-gen micro leadless pacing, our AiBLE surgical suite for cranial and spinal procedures, carotid and Onyx for MMA, for peripheral vascular and neurovascular, just to name a few. So it's not just the depth of the innovation, those big 4 drivers, but it's the breadth of the innovation across virtually all corners of the company that gives us confidence in our ability to drive durable revenue acceleration. So moving beyond innovation, we're also working on accelerating our earnings leverage. As mentioned earlier, we've made enhancements to drive consistent execution and now we are starting to see the benefits.

We've highlighted our 4 generational growth drivers, and we've talked about innovation across the entire portfolio, and we are starting to see the growth accelerate. And again, with the top line coming into place, we're relentlessly pursuing margin expansion, which will improve with volume and mix shifts over time. All of this enables us to increase investment into the future. And you've seen this in the last 2 quarters as our R&D growth has outpaced adjusted revenue growth. And to supplement these organic opportunities, we're going on the offense with strategic M&A, where we're focused on tuck-in high-growth areas that are close to commercialization.

So taken together, this creates a flywheel that we've depicted on the page, which will begin to spin even faster as we continue to drive on this -- deliver on this algorithm and execute against our goals. So we talked a lot about the depth and the breadth of our innovation. We talked about the flywheel and ensuring this is durable. We also talked about our enhanced capabilities to ensure consistent execution. And this is combined with our Medtronic mission and our world-class reputation with physicians, with health system executives, with governments and most importantly, with patients. Look, Medtronic is a pioneer and a trusted partner. So I'll end where I started, it's just an exciting time to be at Medtronic. So thank you.

All right. Can't see -- we brought up Thierry, the CFO. Thierry, welcome to your first JPMorgan Healthcare Conference. Geoff, between the diabetes spin, which I believe you can't comment on given it's an open SEC filing, but the new operating committees, a lot of the new product launches, there's been a lot of transformation at Medtronic over the past few years. How do you feel about where the business is today, the state of the portfolio? And maybe versus a few years ago, how do you feel about the company's competitive positioning and success in some of these new product launches that are driving the top line?

Well, look, the short answer, we feel a lot better. We feel really good about it. I mean, just like I just went through those big new markets that really just unlocked in the last 12 months. I mean, of those 4, CAS is well on its way, but still in its early innings with PFA. And we've got a lot of opportunity in those other 3 that I mentioned. But it's not just those, right? I talked about innovation across the portfolio. We can go business by business because it's -- and there, whether it be neurovascular or peripheral vascular, these you're going to see growth acceleration here. And underneath it all, I like the operating rigor that we've put in place. I talked about the Medtronic Performance System and how we're operating the company and how we're measuring things and tracking these measurements all the way up to the board. So I feel good about it. I feel like it's durable.

You did put in these 2 committees that you're running. One of them is, I believe, a growth committee and one of them is an operations committee. Any early findings you could discuss from them? What are you focused on? And what should we expect in 2026?

Well, the operations committee is really more focused on the margin expansion plans as well as that Medtronic Performance System. So it's both. The one that's been the bigger, I think, enhancement has been the growth committee and because we are going on the offensive on M&A. And these are -- it's very focused on tuck-in M&A around -- in and around the spaces that we're in. But you need to bring -- the Board need to be brought along in that journey and be part of it. And so that committee is set up with the expectation of focused on portfolio, M&A included. There's frequent touch points, way more frequent than our Board meetings. So it allows us to move with speed and agility. So I think as we're leaning into play to tuck-in M&A and playing offense there, this is helping a lot. I don't know, Thierry, if you want to mention anything on the operations committee or anything else there?

I just think when we introduced those 2 committees, we took an opportunity to eliminate some others, so drive some simplicity in the way we -- the Board has operated. And I think the one big benefit that I see is these 2 committees align with the strategic objectives of the company and they align with the way we run the company on a day-to-day basis, right? So if you look at the operating mechanisms we've got, they're really focused on one side on growth and on the other side on the margin improvement. So having that direct link and that direct synchronization between sort of internal operating mechanisms and the way the Board is run, I think, is helpful. It's helping us make decisions faster. And I think it was a good move.

Thierry, it's been almost a year. I think you started in March last year since you've been at Medtronic. Now that you've had some time to get yourself into the business, you came from an autos industry, very different from MedTech, but you did enact a lot of change at your former company. What are some of the things that you see as the strongest components of Medtronic here, maybe from the CFO perspective and some of the things that you're spending your time addressing?

So look, so first of all, I want to say that I'm thrilled to have joined Medtronic, right? I think it's a fantastic franchise. It's a great team, and it's a privilege to be able to join the company and try to contribute. Look, when you do -- when you take an opportunity like this, you do the due diligence kind of on what to expect. And so we had talked about the growth opportunities the ones that Geoff just went through. And so I knew they were there. I underestimated how impactful they would be, the magnitude of these opportunities and how transformational they could be for the future of the company, in particular, in our ability to use part of that growth and reinvest in the future. The second thing is we had talked a lot about the mission.

And one of the reasons I came back to health care because I had been in health care a long time ago was that the mission side of the business. And I knew it was going to be there. I didn't anticipate to what extent, how deep rooted it is in the company and how it drives the behavior towards the customers and towards the patients. To stay on innovation, we had talked about the 4 big opportunities during the interview process. What I had underestimated is the magnitude and the number of innovations we've got across the portfolio. In the business I come from, you do a couple of launches a year, and it's good here. Geoff just went through all the different opportunities that we've got in spine with AiBLE, in neuromodulation with DBS, in carotid, et cetera.

It's across the portfolio. And for me, it's super exciting to see that level of activity and to see the opportunities that it brings ahead of us. One of the reasons I was brought in was to drive margin expansion, right? Because I come from an industry that's super, super cost competitive with very, very thin margins where every dollar counts. And look, I saw that the team has made a lot of progress that the operations are pretty stable and run sustainably, but that we still have a lot of opportunity ahead of us. And I'm excited about what we could do there. And Geoff talked about driving margin expansion to continue to fuel innovation in the future. And I'm super excited about contributing to that.

Maybe to that point, one of the things that you've announced since you've started is you're committing to investing more in R&D as a percentage of sales over the coming years. I think it's 200 basis points over some in definite time period, but the coming years. MedTech is a very innovation-driven top line-focused growth sector. So as you think about spending more, Medtronic is already in some of these fastest growth end markets. They're also some of the most expensive end markets to be in. How are you thinking about prioritizing these R&D dollars, where they're going? Is it to existing markets, new markets? And how should we think about the time frame for contribution of the increased spend?

Yes. So look, if you look at our R&D spend today, at the end of the second quarter, it was about 8.5% of our revenue. And I think the goal that we set to ourselves is to get gradually to about 10%. So it's quite a significant improvement also because today, diabetes is above average in the portfolio. So when we deconsolidate diabetes, it's going to make the ratio go down a little bit so it will give us the opportunity to invest more. So we've started to increase the spend in the first couple of quarters of the year. You've seen it in the first quarter and the second quarter, we've grown R&D faster than we've grown revenue. So the percentage is starting to go up. So from a prioritization perspective, there's, I would say, 3 -- almost 3 layers. The first one is making sure that we capitalize on these generational growth opportunities that are ahead of us, right?

So the first block is continue to capture the opportunity in cardiac ablation, in RDN, in PVL and in Hugo. So the first 4 big blocks. Then we've got a set of businesses that are really high-growth opportunities for us, such as structural heart, such as neuromodulation, for example. And we take these, and we're going to invest more in those relative to other parts of the business. But we also have large franchises that contribute significantly to our profit and to our cash generation. So the third priority is where we can invest in R&D to continue to drive leadership in those franchises. And there it's mostly CRM, I would say, and CST in particular. So continue to invest in CRM with the next-generation Micra, for example, continue to invest in spine to solidify the ecosystem that we've created. So I would say those are the 3 kind of layers that we use for prioritization.

And what we do is we basically rack and stack all the demands that we've got from a funding perspective. And we look at the opportunity that's ahead of us, the payback that we expect, and that's where we're going to put the funds. If you look at what we're doing with the diabetes separation, look, diabetes is a great business. It's got great opportunities ahead of us. But the reality -- ahead of it, but the reality is we could get a better payback and a better return if we invest in some of the other franchises we've got in the portfolio. So the spin of diabetes, that's what it's about. It's about making that business successful on its own, but it's also simplifying our organization and being able to redirect capital to places where we're just simply going to have a better return.

You talked about -- you called it 4 generational product launches. And I imagine everybody here has heard about them, and we've talked about it for a long time. So I don't want to jump into each of those just right yet. But I do want to ask the way I think of it is renal denervation is well underway. That's clearly a very successful launch. Geoff talked about in $2 billion in the first half of, I think, fiscal '26.

Cardiac ablation.

Cardiac ablation. What did I say?

Renal denervation, yes.

Pulsed field ablation, sorry.

That would be great, though. We'd take that.

Hopefully, we get there soon. So when I think about pulsed field ablation, that one is clearly ramped up. And that one, maybe some of the investment is already out there and maybe we start to see the margin benefit come through. When I think about renal denervation, when I think about tibial, when I think about Hugo and surgical robotics, to me, at least, those seem like opportunities that need heavy investment from Medtronic to be able to realize that success. So I guess the question is, is that the right way to think about these 4 opportunities? And if not, how would you characterize sort of the investment and return potentials?

Yes. Look, they're at different stages of their development. To your point, CAS is starting to be an established franchise now. And it's -- however, it's still in the early innings. So we still see accelerated growth. That business grew 50% in Q1. It grew 70% in Q2, and that growth rate is going to continue to accelerate. But we're going to continue to invest in it. We're -- the next generation Geoff mentioned with Sphere-360 for us is really important. And as that business grow, the margin is going to continue to improve, and it will be an opportunity to have more funds to reinvest in the other franchises. RDN is very early on in the development. And it's clear that we're positioned ahead of a lot of our competitors there. In fact, we're clearly leading in this field. But we want to keep it that way.

And so we're already fueling investment to do radial access to improve the performance, to look at other indications that we could expand to the portfolio. And I think Hugo is the same. It's very early on in the development. We just got the indication on urology, but we want to expand that, hernia, gynecology, et cetera. And for sure, we're going to differentiatedly invest in those areas to capture the maximum of growth. But we can't stop investment in the rest of the franchises. As I said, those are not the only growth drivers we've got in the portfolio. And we have to secure the leadership positions that we've got -- that we've acquired in some other large cash-generating businesses in the portfolio.

Geoff, I think it was this conference last year, you first started ramping up your mentioning of tuck-in M&A and being more aggressive with that. You now have the growth committee, Medtronic, as you just talked about, looking more at tuck-in M&A. How do you see tuck-in M&A as part of your overall growth strategy? Is it supplemental to internal innovation? Is it stuff you can't get to? How are you thinking about balancing internal where there is a good amount of innovation already versus external? And when do you think we can start to see some of that tuck-in M&A flow through?

Look, I think we've got a pretty robust pipeline right now. So I don't think it will be -- I can't predict the timing of these things, but it's not way out there, right? It's pretty tangible inside the company right now. So a lot going on. And I do think it's -- everything you said, it's supplemental, right? And we've got some real strengths in our commercial go-to-market and real presence, and we've got to feed that beast. And some of it comes from organic and more of it needs to come from inorganic than it's come over the last couple of years. And so that's how we're seeing it. And -- but it's -- that we're focused on these areas, a couple of themes. One is in these high-growth areas that we talked about.

And we'd even -- some of these are such must-win competitive areas that you might have an organic program and go after an inorganic program and see which one wins or have 2 organic bets. We've got a number of -- and venture investing is a big part of this, too, right? So we've got a number of venture investments that are in 2 companies that one of them, by definition, both won't be successful, right? They're both looking at the same thing. So much more aggressive earlier on the venture, multiple shots on goal, focused on the high-growth areas. And also the other theme I'd say is around these procedures, so enabling technology around the procedure like CAS, like ablation or more even around surgical robotics technology around the procedures, I think those are some of the themes.

Great. And when you think about tuck-in M&A, I would generally think something in the -- for a company Medtronic size, something like low to mid-single-digit billion dollars. Is that how you would characterize tuck-in M&A?

Sure.

Yes. Maybe to stick on capital allocation further along. So you have internal innovation, you have tuck-in M&A. You have the dividend that you pay out. Going forward, from today on, how would you prioritize your free cash flow dollars? And are there any changes that we should expect moving forward versus what you've had in the past?

Sure. So look, we talked about funding organic R&D first, right? And so again, we've given clear signs of the direction that we're taking in that area. Second priority is the tuck-in M&A that we just went through. Look, we've got significant firepower with the balance sheet that we've got today to be able to carry out a meaningful number of meaningful acquisitions without any problem. And the dividend is not getting in the way of that, right? So there's no change in the dividend policy. It's what a lot of our investors expect us to do, and we're going to keep doing that. But I think clearly, what's changing versus the last few years is coming back to doing more M&A. I think we went through a period that Geoff mentioned around solidifying the operations and improving operations on a day-to-day basis. And now we're there. So we've earned the right to do these acquisitions, and we've got the capacity. So we're going to step up in that area.

Geoff, it was a year ago exactly today that you got the NCA for renal denervation that got approved. I think it got finalized with the government shutdown in November.

Right.

And so now it's been, let's call it, 2 months since the NCD went into effect. Any early comments you could give us on how the launch is progressing? Obviously, we'll wait until February this year for...

Yes, sure. Look, the leading indicators are good, right? You've got -- I'd say, first, there's the clinical results, I think, are very positive, I'd say, are surprising docs to the upside, right? They -- in many cases, we're looking at the trial data and not really equating it to the real world because what they're seeing in the real world is people that are pretty sick and not taking their meds. And then what happens with this procedure is it's simple, it's fast, it's very tolerable for patients and they get a pretty quick drop in blood pressure, and it sustains. So the impact on patients' lives and their ability to come off the meds, I think, are very strong and better than expected from a physician standpoint. The other thing we've learned is that hospitals were cautious about really the docs are very excited about it, but hospitals were cautious because of the economics. They've been burned before.

They wanted to see not just the NCD come into place, but they wanted to see a few reps. So they'd say, okay, now that it's in place, okay, I'll give you 15, 20 cases to the doc. And then I want to pause and see if I get paid. And so we've had to work with them to make sure they're coding it right and all that. But that is cranking through now. And even just last week, we got more positive news on the NCD, and that went up a couple of thousand dollars. So it's -- those signs are all positive. And what's happening now is now the sites that had, the systems that had hypertension programs, they're moving through and others that didn't have to build those hypertension programs.

Medicare is half the market, I believe, roughly commercial is the other half. What's the latest progress on commercial coverage for...?

I think we said -- we have an update on our last earnings call, we said another 30 -- we're up to 30 million patients now. So the commercial coverage is happening probably a little faster than I would have thought. I thought they would have pushed back a little longer. But there's just such a strong patient pool here that I think it's going to move the coverage faster.

So do you think this is something that could ramp kind of on par with what we saw in pulsed field ablation?

Well, no, because that was a shift. I mean that was a shift from one established procedure shift from one technology to the other. Here, we're building a new. So I mean, it will get -- we believe it's going to get that big, right? But the ramp is going to take longer than that.

If only every product launch could be as successful as that, it'd be good.

Yes. Yes. Yes.

Maybe with the last few minutes, we could shift over to surgical robotics. Hugo just got approval in the FDA for urology. How are you thinking about the rollout here? We saw your competitor take about 1.5 years in a limited launch with their new system. We have general surgery approval coming from you in the future. How are you thinking about limited launch versus full launch and the uptake there?

Look, we're starting with a purposeful launch here. I know you want to call it a limited launch, purposeful launch, but we're very focused on the first impressions of the physicians and make sure we get this right. We've come a long way. We've invested a lot. And with Hugo, like I said in the prepared remarks, you've got -- one, it's the first -- in our opinion, the first real competitive offering to Intuitive here in the U.S. And so that's one. But two, I think what's underappreciated is our ability to contract across the whole surgical suite, open, lap and robotic, right? In today's day and age with the economics of hospitals, the challenges they're facing, the ability to do that efficiently is a big deal.

And remember, one of the key features of Hugo is that the tower that is used for it can also be used for laparoscopic. You don't need a separate room. There's a number of features also that plays into the economics. And then from a clinical perspective, there's physicians are telling us they really like the way it shines in certain procedures, right, where they want a little more access to the patients, so you can move the arms around. They want to come in at a different angle, like hernia, it really shines in hernia, for example. So there's some real economic advantages and then there's some clinical advantages that we feel good about, over time, building a nice market position here globally and here in the U.S.

Great. Unfortunately, we're out of time. Thanks for a great discussion. Thanks, everybody, for coming.

Thank you.

Hello, everyone, and thanks for joining us today for our fiscal 20,162nd quarter video earnings webcast. I'm Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations. Joining me here today are Geof Martha, Chairman and Chief Executive Officer; and Thierry Pieton, Chief Financial Officer. Geoff and Thierry will provide comments on the results of our second quarter, which ended on October 24, 2025, and our outlook for the remainder of fiscal year '26.

After our prepared remarks, we'll take questions from the sell-side analysts that cover the company. Today's program should last about an hour.

Earlier this morning, we issued a press release discussing our results and containing several financial schedules. We also posted an earnings presentation that provides additional details on our performance. The presentation can be accessed in our earnings press release or on our website at investorrelations.medtronic.com.

During today's program, many of the statements we make may be considered forward-looking statements. and actual results may differ materially from those projected in any forward-looking statement. Additional information concerning factors that could cause our actual results to differ is contained in our periodic reports and other filings that we make with the SEC, and we do not undertake to update any forward-looking statement. Unless we say otherwise, all comparisons are on a year-over-year basis and revenue comparisons are made on an organic basis, which excludes the impact of foreign exchange, Second quarter revenue in the current and prior year from our divestiture this quarter of the Dutch Obesity Clinic, also known as NOK, and second quarter revenue in the current and prior year reported as Other.

References to sequential revenue changes compared to the first quarter of fiscal '26 and are made on an as-reported basis. All share references are on a revenue and year-over-year basis and compare our second fiscal quarter to our competitors' third calendar quarter. Reconciliations of all non-GAAP financial measures can be found in our earnings press release or on our website at investorrelations.medtronic.com. And finally, our EPS guidance does not include any charges or gains that would be reported as non-GAAP adjustments to earnings during the fiscal year.

With that, over to you, Geoff.

Okay. Thanks, Ryan, and hello, everyone. Last quarter, I told you that Medtronic is on the cusp of an acceleration on our financial results and our strategy. Well, today, I'm pleased to share that because of our organization's relentless focus, that acceleration is indeed underway. We delivered a strong second quarter. Both our revenue and EPS beat expectations. Looking across our business, procedure volumes and end markets are robust, and we're bringing Medtronic's full capabilities to bear as we launch innovative technologies and execute ahead of plan in some of the most attractive and fast-growing end markets in med tech. We're glad to be able to raise our revenue growth and EPS guidance for the full year on the back of this building progress. This quarter, we accelerated our growth with significant contributions from our cardiac ablation business as promised.

Looking ahead, there's even more that Medtronic is capable. We're positioning ourselves for even greater acceleration in revenue growth in the back half of the year and beyond. And our momentum is fueled by our enterprise growth drivers, including our PFA franchise for AFib, SIMPLICITY for hypertension, Hugo and soft tissue robotics and Ulta Viva for incontinence. Look, these are game changers, and they'll power our trajectory. And at this pivotal inflection point in our growth journey, we recognize the need to capitalize on the incredible market opportunities before us. So we've scaled manufacturing to support our acceleration. In this quarter, we took the opportunity to increase OpEx investments to support our revenue growth momentum. We did all this while still delivering outsized EPS growth relative to our guidance.

Overall, we shifted to a growth mindset. Besides our organic programs, we're focused on pursuing tuck-in M&A and executing strategic portfolio management. Now let's get into the details on our enterprise growth drivers, one of them powered our growth acceleration this quarter. And together, all of them will fuel our total company revenue growth in the quarters ahead.

In cardiac ablation, our PFA franchise is generating just a ton of momentum. We grew 71%, which is a strong acceleration from last quarter's nearly 50% cash growth. This is the highest growth rate of any company in this large and fast-growing space. We're winning share as our PFA franchise grew over 300% in the U.S. as well as in international markets. This was based on the strength of our Affera mapping system and our Sphere-9 dual energy and high-density mapping catheter. Look, physicians tell us that they appreciate not only the shorter procedure times that they're seeing with the Affera, but increasingly, they're calling out its outstanding durability as well. And demand continues to be extremely high as we hear repeatedly from customers that they want to purchase additional Affera systems to expand into even more of their labs. And in the vast majority of instances, when a new Affera system goes into a lab, we take the majority of the AF procedure share in that lab.

Our plants have scaled, as I mentioned earlier, to meet the challenge, and our mapping hiring is going really well. And as a result, we've doubled our installed base of Affera mapping systems during the quarter. And given the economics of this business with capital and consumables, our mapping system sales are a strong leading indicator of future revenue growth and margin expansion. So we're in the early -- we're still in the early parts of this rollout. And we expect revenue acceleration to continue with an even higher cash growth in Q3. We remain on track to double the revenue of this business soon, adding an incremental $1 billion off the $1 billion FY '25 base. Look, we're not stopping there. With our pipeline, we're bringing Affera technology to the single-shot segment with Sphere-360. EPs tell us that 360 is the most anticipated PFA catheter out there. given the strength of its early clinical data. We've submitted the IDE to the FDA to get approval for our U.S. pivotal trial, which we're expecting to start in Q3. So the EP ablation space is now over $12 billion. It's growing mid-20s. And with our low double-digit share and the high demand I just talked about for the current portfolio and our pipeline, we see a long runway to gain significant share and add meaningful growth to Medtronic.

Now on top of that growth, we're launching as the clear market leader in 2 very large end markets, our Simplicity procedure for hypertension and Ulta Viva for incontinence. And we're excited to have received the final Medicare NCD for Simplicity 3 weeks ago. So now in addition to a broad label from the FDA, we have an excellent coverage outcome from CMS. The final NCD enables broad access and removes certain patient pathway barriers that were in the original proposal, including reducing in-person visits, removing a kidney function exclusion and cutting in half the time requirement for adherence to meds. It also highlights patient quality of life as an important consideration. So the NCD gives physicians many avenues to bring Simplicity to patients.

Additionally, we are currently the only company to meet the full NCD criteria with an approved continued evidence development plan, and on the commercial payer front, we picked up significant momentum with wins during the quarter, including HCSC, regions and several Blue Cross Blue Shield plans that collectively cover 30 million lives.

Shifting to efficacy. Medtronic is the runaway leader with Ardian in clinical data, and we continue to add to it. Only Simplicity RF Ardian has consistently shown sustained and improving blood pressure reductions in the long term. This is definitively unique to us as we've not seen this with the ultrasound devices. This sets the standard that all other devices must now meet. And last month at TCT, we shared 3-year data from our ONMED trial that continue to show the procedure is effective over the long term. Patients who underwent the Simplicity procedure experienced an 18.5 point average drop in systolic blood pressure.

We also completed enrollment in our Spiral Affirm trial, which aims to expand simplicity into high-risk subgroups, including people with isolated systolic hypertension. The first data from a subset of this trial was also shown at TCT with very strong results. We're using these results in ongoing discussions with the FDA.

So Simplicity represents a massive multibillion-dollar opportunity for Medtronic with an addressable market of 18 million people in the U.S. with uncontrolled hypertension. And now with a broad NCD in place, and commercial payers coming online faster than anticipated, this isn't a question of if or even how big, it's a question of how fast.

Now we have not incorporated much Simplicity revenue into our back half guidance, but we are sprinting after this opportunity. We have supply. We've ramped up physician training and market development activities with many hospitals initiating Simplicity programs across the country. And now we're increasing our consumer awareness programs. And as a result, we expect our revenue to pick up in the back half of the fiscal year and ramp over the next few quarters and meaningfully contribute to Medtronic for years to come.

Now shifting to Altaviva. We're seeing very positive signs in the first several weeks of the U.S. launch. Physician training programs are oversubscribed, and we're expanding training capacity to meet this demand. Physicians are stacking cases and early media coverage has driven a surge in consumer search activity. Altaviva is a simple option to treat urinary urges and involuntary leaks, which affect 16 million people in the U.S. This small device is inserted just below the skin but above the fashion near the ankle. The procedure is minimally invasive, doesn't require sedation and the patient goes home with a therapy activated. So they're not waiting for follow-up appointments to feel the results. The device is only recharged once or twice a year, eliminating the need for daily at-home charging equipment, and it has a 15-year battery. So we believe Altaviva will add meaningful growth to our Pelvic Health business, and be a Medtronic growth driver again for years to come. And more importantly, it is meaningful for patients.

This is our first patient in South Carolina, who is dancing to Jingle Bell rock. It's getting up to be that time of the year. And it's a wonderful video.

In addition to these enterprise growth drivers, we're seeing improvements in many of our other businesses as we execute on new product introductions, getting products to market ahead of schedule and ensuring strong commercial follow-through.

So with that, I'm going to turn it over to Thierry to cover the details of our business performance, financials and our guidance.

Thanks, Geoff. Hi, everyone. I appreciate everyone joining us today. So I'll start with our Cardiovascular portfolio where we grew 9%. This was our strongest growth in over a decade, excluding the easy comparisons we had after the pandemic. The growth acceleration was driven by our building momentum in CAS, which Geoff walked you through, and it's worth noting that PFA is now 75% of our cardiac ablation revenue. Our PFA growth significantly offset the 40% declines we had in cryo, and 90% of our remaining cryo revenue is in markets outside of the U.S. And look, it wasn't just CAS. The rest of our cardiovascular portfolio grew a combined mid-single digits. Cardiac Rhythm Management grew 5%, with 18% growth in micro leadless pacemakers, and nearly 80% growth in Aurora EV ICDs.

In structural heart, we grew 7% on the strength of the Evolut TAVR platform. In peripheral vascular, we grew low single digits, and we expect growth to improve as we continue to launch the Neurogard-IEP carotid stent and begin the launch of our Liberant mechanical thrombectomy system.

Next, in our neuroscience portfolio, our growth returned to mid-single digits, as expected, with growth of 4%. In Cranial and Spinal Technologies, we grew 5%. That included 8% growth in core Spine, both globally and in the U.S., and 5% in neurosurgery capital equipment. Our Spineable ecosystem, which includes AI-enabled preoperative planning software, and enabling capital equipment, including robotics, navigation, imaging, and powered surgical instruments, continues to attract strong spine surgeon adoption and drive meaningful share gains. And this is enabling strong pull-through of our core spine hardware.

Our Specialty Therapies businesses had flat results in Q2 and expected improvement from last quarter, driven by ENT and Neurovascular. We have clear line of sight to continued improvement in specialty therapies next quarter as we accelerate growth in both Neurovascular and Pelvic Health.

In Neurovascular, growth will improve as we anniversary the vast majority of China VBP in January. We also expect an increasing growth contribution from the Neuroguard carotid stent launch, which is being sold by both our Peripheral Vascular and Neurovascular businesses.

In Pelvic Health, we expect growth to accelerate on the Altaviva launch that Geoff outlined.

In Neuromodulation, we grew 7%, both pain stem and brain modulation grew high single digits as we continue the rollout of our [indiscernible] SCS and BrainSense A DBS systems. The market continues to appreciate our differentiated fully closed-loop technology with responsive real-time therapy adjustments that's available in both of these products.

Next, our MedSurg portfolio grew 1% as expected. Our Surgical business also grew 1%, impacted as we anticipated, by the timing of certain tenders in emerging markets and the ongoing, but stable market pressures from bariatric surgery and the shift to robotics. We expect a slight rebound in Surgical in the back half, and over time, we expect growth to continue to improve as we enter new markets with Hugo.

In the back half of this fiscal year, we expect the FDA to approve Hugo with a urology indication and we'll start our entrance in the U.S. We also continue to make progress on expanding indications. During the quarter, we presented our Enable Hernia Repair study, which met its safety and effectiveness endpoints. And we kicked off our Embrace gynecology U.S. pivotal study last month. This builds on the momentum from the positive results of our international gyn study, which we shared at SRS in July.

Given our experience in international markets, we have developed a clear understanding of the differentiated features that will make our robotics program successful. This includes Hugo's modularity and open console. It also includes continuously adding advanced technologies such as our ICG imaging and instrumentation like LigaSure RAS.

Our touch surgery digital ecosystem is a force multiplier for robotics and for laparoscopic surgery. Adoption is building momentum and bringing AI into operating rooms in over 30 countries.

Beyond the features, we're also leveraging our deep partnerships with customers through our training, support and through our service. We look forward to robotics becoming a more meaningful growth driver over time.

Next, our Endoscopy business grew 8%. This was driven by double-digit growth in our esophageal products as well as in GI Genius, our AI-powered solution used to detect polyps during colonoscopy.

Wrapping up our business performance, our Diabetes business, or MiniMed, as it will be called post-separation, grew high single digits. We had particular strength in international markets, which grew 11%. As expected, the U.S. was lower this quarter, in large part due to a decline in new orders as customers anticipated the launch of our new sensors. As we've started accepting orders, we're seeing this pent-up demand materialize.

There's a lot of excitement behind both the Simplera Sync and Instinct sensors. Look, with the Simplera, we continue to ramp manufacturing volume to support its European launch. As that ramp continues, we plan to roll it out more broadly to U.S. consumers later this fiscal year. And ahead of that, we started accepting orders during the quarter. With the Instinct sensor, we started taking preorders in the U.S. during the last month of the quarter, and we expect to begin shipping in late November. We accumulated more than 35,000 U.S. customer orders for Simplera Sync and preorders for Instant. Around 25% of these orders are from new pump users or our Medtronic pump users who were not using our CGM. The rest of these orders are current customers in our installed base, upgrading to the new sensors.

We also saw over 9,000 HCPs in the U.S. who are new Medtronic prescribers. Look, for those of you who follow this space, you know how big a deal these numbers are and the impact there expected to have on increasing our installed base. We expect the demand for our new sensors to accelerate our U.S. growth in the back half of the fiscal year.

Our Diabetes business is in a strong innovation cycle. We've had a lot of great news in the last few months as our teams execute on the pipeline. In July, the 780G system received CE Mark for 3 expanded indications, including for type 2, for children as young as 2 and during pregnancy. In September, the U.S. FDA also approved 780G for people with type 2 diabetes. And they cared our SmartGuard algorithm that enable integration with the Instinct sensor.

Earlier this month, we received FDA approval to start the U.S. pivotal for Vivera, our third-generation algorithm. We also continue to make progress with our new AID systems, MiniMed Flex and MiniMed fit. We remain on track to submit Flex, our next-generation durable pump, to the U.S. FDA. And and with Fit, our AID patch system, we intend to submit to the U.S. FDA by the fall of next year.

Look, finally, our planned separation of MiniMed is on track. Our preferred path continues to be a 2-step IPO and split. We continue to expect the separation to be completed by the end of calendar year '26.

So we have a lot of momentum with Diabetes given the order inflection and progress on the pipeline and separation. And you're hearing today that this momentum acceleration extends across the enterprise as we advance our pipeline and deliver growth.

Now turning to the financials. The second quarter revenue of $9 billion grew 6.6% reported and 5.5% organic. That's an acceleration from last quarter and 75 basis points ahead of the midpoint of our guidance. Our revenue from a geographic perspective was balanced, with double-digit growth in Japan and mid-single-digit growth in the U.S., in Western Europe and China.

In China, we're driving growth even as we go through ongoing, but very manageable volume-based procurement in a few businesses.

Our adjusted gross margin was 65.9%, up 70 basis points year-over-year. Similar to last quarter, I'll walk you through the main components. So we got 30 basis points again from pricing as well as 40 basis points from our COGS efficiency programs, net of inflation. Importantly, margin headwinds from ramping up our manufacturing capacity on Affera are now behind us. So together, we drove a 70-basis-point operational improvement in gross margin in the quarter. This was offset by business mix, which represented a headwind of 80 basis points, split roughly equally between Cardiac Ablation and Diabetes.

As I noted last quarter, CAS is impacted by the mix of lower-margin capital to higher-margin catheters and Diabetes is early in its manufacturing ramp-up of Simplera. Over time, we expect both of these to improve as we scale our CAS business and separate the Diabetes business.

Next, tariffs were a 20 basis points headwind. And finally, FX was about 100 basis points tailwind.

Adjusted R&D was 8.4% of revenue and increased 8.9%, which is 230 basis points ahead of reported revenue growth. We've increased R&D investments in our core right-to-win franchises where we've identified opportunities to accelerate top line growth and improve our share in the near, mid- and long term.

SG&A was 32.7% of revenue, up 20 basis points versus last year. As Geoff mentioned, we proactively took the opportunity to increase spending to accelerate our PFA and Ardian launches in light of the considerable market demand and compelling near- and medium-term outlooks. At the same time, we delivered disciplined leverage on G&A, with growth at under half the rate of our revenue growth.

Our adjusted op profit was $2.2 billion, an increase of 6%. This resulted in an adjusted operating margin of 24.1%, down 20 basis points year-over-year, but an increase of 50 basis points sequentially. Our adjusted tax rate was 16.4%. Q2 tax expense was lower than expected, which is largely due to timing, and which we expect to offset in the fourth quarter.

All in all, adjusted EPS was $1.36, an increase of 8% and $0.05 above the midpoint of our guidance.

Now let's cover our guidance. Given our outperformance in the first half of the year as well as the confidence we have in our revenue growth acceleration, we're raising our full year revenue guidance today. Year-to-date, we've delivered 5.2% organic growth, and we expect this to further accelerate in the back half of the year. As a result, we now expect fiscal 2016 revenue growth of approximately 5.5%, a 50-basis-point increase from the prior guidance. In the third quarter, we're also expecting approximately 5.5% growth and Q4 will be even stronger.

Based on recent rates, we now see an FX tailwind to fiscal '26 revenue of $625 million to $725 million. including $150 million to $200 million tailwind in the third quarter.

Moving down the P&L. We expect our fiscal '26 gross margin to be slightly up ex tariffs, with pricing, FX and COGS efficiency programs more than offsetting the negative impacts of business mix, primarily from Cardiac Ablation and Diabetes. We anticipate a tariff impact to COGS of approximately $185 million, including $90 million to $95 million in the third quarter. Including tariffs, we expect the fiscal '26 gross margin decrease of roughly 40 basis points.

We'll continue to fund R&D to grow greater than sales. With SG&A in light of the outsized demand and building momentum for our enterprise growth drivers, we're capitalizing on every opportunity to accelerate our top line by strategically increasing sales and marketing investment in key programs, but we'll still deliver SG&A leverage on the 4 year by rigorously managing our G&A line.

Taking all of this together, we expect fiscal '26 adjusted operating profit to grow approximately 5% or 7% excluding tariffs. Our fiscal '26 operating margin is expected to be roughly flat ex tariffs and down about 50 basis points, including the tariffs impact.

Now coming to EPS, second quarter EPS came in $0.05 above the midpoint of our guidance, $0.035 of this beat was from reduced tax expense, as I mentioned earlier, that we now expect to occur in Q4. We're flowing through the remainder of the Q2 beat and increasing our fiscal '26 EPS guidance to a new range of $5.62 to $5.66 versus the prior range of $5.60 to $5.66. For Q3, we expect EPS in the range of $1.32 to $1.34.

We're expecting margins to be down a couple of hundred basis points in Q3 as the quarter includes half the annual impact of tariffs. In addition, the expected growth acceleration in CAS and Diabetes will continue to impact business mix. And Q3 is typically our lowest quarter for generating COGS efficiency savings given the holidays. However, we do expect Q4 margins to increase year-over-year and shows strong sequential improvement.

Looking ahead to next year, we continue to expect high single-digit EPS growth in fiscal year '27, driven by accelerating revenue growth, a lesser impact of business mix from CAS and Diabetes on the gross margin line, and leverage on SG&A while we continue to drive higher investments in R&D and sales and marketing.

Look, we remain committed to driving both revenue and earnings growth and believe strongly that our financial algorithm will flow from our current focus on building sustained top line momentum.

Geoff, back to you.

Okay. Thank you, Thierry. Before we go to Q&A, let me share a few quick thoughts. So when you look at our top line, you can really see the focus we've had on allocating capital and executing on our pipeline is all now coming together to drive meaningful acceleration in our growth. We're on an incredible trajectory with PFA, and we're just getting started with some big new opportunities with Simplicity and Altaviva. At the same time, our newly formed Board committees are helping as we act decisively and with increased speed. We're executing on margin enhancement programs to fuel our enterprise growth drivers, the future pipeline and earnings leverage. We continue to evaluate the overall portfolio at every level as well as tuck-in M&A, and we are committed to growing above our WAMGR while also raising the amber of the company over time. And I'm looking forward to diving deeper into all of this with you at our Investor Day next year.

So bottom line, we're executing on our commitments. You can see it in our numbers, and with every quarter, we're picking up more momentum. We're pleased with the progress, but eager to continue proving Medtronic has turned the page and entered a new period of greater revenue and earnings growth.

Finally, I want to thank our employees who are watching today around the world. Thank you. Thank you for your steadfast commitment to the Medtronic mission and to the patients that you and our customers serve every day. I also appreciate your continued execution, which allows us to collectively deliver on our total company performance. So thank you.

Okay. Now it's time to move on to Q&A, where we're going to try to get to as many analysts as possible. [Operator Instructions]. If you have additional questions, you can reach out to Ryan and the Investor Relations team after the call. So Ryan, can you please give the Q&A instructions and queue up the analysts?

[Operator Instructions] Finally, please be advised that this Q&A session is being recorded. Okay. Let's take the first question from Patrick Wood at Morgan Stanley.

I'll keep it to one, of course. I'd love to start with Simplicity. You mentioned the commercial discussions happening faster than kind of expected. Obviously, without diving into any individual payer, how are those reflective relative to the NCD? Like are there restrictions being put on? What is the sort of tone of the conversation, and how are the commercial payers looking to introduce us within their patient pool?

Yes. Thanks for the question, Patrick. The commercial payers, like you mentioned -- I mentioned in the commentary, they are coming online faster than I believe we anticipated. They're getting a lot of push from patients as well. In terms of restrictions, I would say -- first of all, I'd say, look, the NCD is -- the Medicare NCD is broad, and it's better than we anticipated. It's better than the proposal. So we're comparing it to that. The 1 area that I've heard, and in addition, on the NCD, they've incorporated physician -- for lack of a better word, physician discretion, patient discretion on, hey, as a patient, can I tolerate these meds, or does the physician feel like the patient cannot tolerate the meds. That gives them that avenue to move to Ardian to Simplicity.

In the commercial payers, we're seeing where there is 1 difference that I know of is around the medication. It's more of an emphasis on being on a few medications for a while. So that's the 1 area that I'm aware of. Patrick, and we'll keep everyone posted as this -- as we get more commercial payers online.

We'll take the next question from Travis Steed at BofA Global Securities.

Congrats on a good quarter. I guess, first of all, the implied second half guide around 6%, and you kind of think about the 2 buckets of the pipeline and then end of the base business? Maybe talk about kind of what you're assuming on Ardian in the second half and then also the base business, why I'm confident in the slight rebound in MedSurg and kind of the confidence to keep the base business humming. And then on the margins in the second half, this quarter, we didn't see quite as much margin flow-through, just assuming that changes in the second half, the revenue upside leads to more margin upside in the second half?

Do you want to take that one?

So maybe I'll start with the margin. Travis, thanks for the question. Look, we described the momentum that we had from a commercial perspective in the second quarter. And pretty early on in the quarter, we saw the order intake being pretty strong. We also saw that we were going to have a little bit of upside from a tax perspective, even though that's timing, but we did see it coming early on in the quarter. And so we just made a decision to go invest in the places that are going to drive the growth going forward. So we made some significant investments in the mappers structure, for example, in cardiac ablation. We started to build up the capability from a direct marketing on the Simplicity side.

So we took the opportunity that we were going to see upside on revenue and a little bit on the tax line just to lean into the investment to make sure we fully capture the opportunities that are ahead of us. And so you saw that in R&D. It's the second quarter where we have R&D growth that's pretty significantly higher than the revenue growth. And this quarter, specifically, you saw it on the SG&A line, where we put, as I said, quite a bit of investment, especially in sales and marketing, while keeping the G&A line pretty constrained.

So going forward into the rest of the year, we'll keep investing in these growth areas. You'll see R&D continue to ramp up. As you know, we're targeting to get over time to roughly about 10% of our revenue on the R&D line.

On SG&A, though, you should expect to see leverage in the second half, so SG&A together. So we'll start seeing a lift there. And so ex tariffs, we'll have gross margin and operating margin leverage in the second half and -- but we'll have to contend with the tariff impact. So all in all, on a full year basis, you'll see gross margin slightly up before tariffs, down about 50 basis points post tariffs. And at the operating margin level, you'll see operating margin roughly flat year-over-year ex tariffs and slightly down with the impact of tariffs.

So look, it's all about capitalizing on the opportunities that we've got ahead of us, and that's what we'll keep doing. But again, our second half leverage on both those lines.

So on the revenue, as you see from the guidance, we're seeing -- we're looking at a back half ramp here that will extend into 2017. And the way I'd break it down, I mean, a big piece of that is these growth drivers that are kicking in, these multibillion-dollar opportunities. In terms of the back half, though, most of that is really coming from PFA. So -- in terms of the new big ones, right? When you think about PFA, Simplicity, Altaviva and we have Hugo coming, those are, we would say, our big multibillion-dollar upmarket opportunities. In the back half, the contribution will be more from PMA in that category. PFA is, I mean, it's cranking right now. We've got a lot of momentum there.

When it comes to Simplicity and obviously, Simplicity in Altaviva are approved in the U.S. On Simplicity, I'd say we're going to see it start to tick up in the back half of the year and then ramp in the quarter following that. Like I said, between the NCD and the commercial payers coming online, this market is really a best case scenario. It's as big as what we said it is. It's not about if or even how big, like it's as big as we said, it's really how fast. And we're measuring that speed of adoption in quarters, not years.

Altaviva, again, just approved a lot of great leading indicators, physician training is over booked, and we can talk more about that if I get questions on why we're so excited. Again, it will start to contribute in the back half a little bit. And then Hugo, we don't have too much on, but we do still expect the approval in the back half of our year.

Then there's another -- getting to the base business, Diabetes pops back up as our new sensors are available. Neuromodulation continues to be strong. CST will be -- continue to be strong. CRM had 2 really good -- a really good Q2. I don't know if we're going to have that same level of growth there, but still a strong growth there. And then you've got 2 other businesses that I'll call it tick up, incrementally increase their growth rate, Peripheral Vascular with the carotid stent mechanical thrombectomy coming. And then Neurovascular, again, it's also selling a carotid stent, got some hemorrhagic products coming, and they're just lapping some issues, a recall and then lapping DBP here.

So the base business is a big contributor. PFA is a big contributor and then you're going to start to see Simplicity, Altaviva and a little bit of Hugo.

Next, we'll go to the line of Vijay Kumar at Evercore ISI.

Congrats on a nice print here. And Jeff, I had maybe a new product question, a 2-parter, if you will. One on Affera, Jeff, do you feel like we have enough mappers now? And if supply in a place enough where you can hit the $2 billion? How are you thinking about supply and mapping? And then on TBL, we've got some good feedback on cannibalization of whether TBL could cannibalize BOTOX procedures. Could TBL be a $1 billion product for you guys down the road?

So I'll start with the PFA questions. On the supply that we are -- that's not holding us back. So supply is in a good spot. And then on the mappers, the Mapper hiring is going well, right? We're staying ahead, but I wish the buffer a little bit more because the growth is tremendous. But we are staying ahead on the mappers and the supply is not an issue. And like I said, our PFA business is really humming.

I was just with a big customer yesterday. They've got 2 systems. They laid out 3 more that they're going to buy. And just talking about once they put especially Affera, once they put that in 1 of their hospitals, how it kind of takes all the market share or the majority of the market share there for all types of cases. There's just all these benefits there. So feeling really good about that. And again, this mapper hiring has been a Medtronic, not just our Cardiac Ablation business, but a Medtronic effort, and our HR team is doing a hell of a job there.

And then on Tibial, look, Tibial is something I think everyone needs to invest a little bit of time in here. It's a huge market, 46 million people in the U.S. with overactive bladder, and of that 16 million with urinary urge incontinence where this really shines. And it takes the therapy versus sacral, which works really well. It's been a great market for us. There's been some channel disruption in the market lately, but it's still a great market and works really well for patients. But it does take weeks or months to get that therapy to a patient from when they start versus Tibial is less than a day.

So what you're seeing here is with Tibial, right, you have to do both with sacral nerve. You have to do a trial, then you have to go in for the implant, then the patient leaves without the therapy turned on, has to come back to get it activated, versus Tibial, this all happens in a day and the procedure is easier. And when patients, to get to your core of your question, when they're presented with options, all of their options, sacral nerve, Tibial, BOTOX, they choose -- they tend to choose the Tibial. So we do think it will take share from BOTOX.

And I would emphasize that this, we believe, look, there's a very strong place for sacral nerver. Definitely been -- this is an incremental opportunity on top of our sacra business. And so this -- that sacral combined with tibial, given that it's going to be incremental, this is going to make that business, that Pelvic Health business, a growth driver for the company. That's what I'll say about that. It's going to meaningfully improve the growth rate of that business.

Next, let's go to the line of Robbie Marcus at JPMorgan. Please go ahead, Robbie.

Thierry, I wanted to ask, you talked about strategically reinvesting into SG&A and over time materially increasing R&D, I think, up to 200 basis points. How are you thinking about where those dollars are going? How soon should we be thinking about that? And just help us think about the cadence and the ability to still grow operating margin in the face of higher investment?

Yes. Robbie, thanks for the question. So first, where the dollars are going? So there are really 2 different categories, I would say. One is to, as I said, to capitalize to the maximum extent possible on the growth drivers that are ahead of us. So there's a significant amount of investment that's going to to CAS, to Ardian, to Altaviva, to -- and obviously, to Hugo with a profile that's a little bit more long term. The -- there are other growth drivers that we're funding at the same time such as structural heart and Neuromodulation, for example.

The second category of where we're putting investment is to make sure that we keep the leading edge from a technology perspective in the key franchises that are our bread and butter. So there's overinvestment compared to the average of the business in CRM, for example, in next generation of Micra. There's -- and there is significant investment going in CST to continue to develop the ecosystem that, that business has created around AiBLE that has enabled us to make the CST business more sticky with our customers from a device perspective and gradually improve the margins. So it's really those 2 areas, capitalize on the growth drivers on 1 hand and keep the edge on innovation in the key franchises on the other side.

From a sequence perspective, look, I would say third quarter, we made a pretty deliberate strong investment because we saw the upside coming. You'll see a bit less of that already in the second half. So as I said, you should see our leverage on the SG&A line in the second half of the year already. But maybe going into the longer term, look, we've tried to give as much clarity as possible on the gross margin line, so that you see the dynamics.

If you look at what happened this quarter, we had about 40 basis points of pricing and about 30 basis points or 40 basis points of cost out. That's been sort of a recurring performance over the last quarters, and we expect that to continue over time, right? So we're generating between those 2 lines, 70 to 80 basis points of gross margin improvement, right? And this quarter, you had about 80 basis points of negative mix and 20 basis points of tariffs, and that was offset with FX.

Going forward, we expect that negative mix to start getting better towards the second half of '27. So for the rest of the year, it's still going to be a pretty significant headwind as CAS and Diabetes continue to accelerate. And in the second half of '27, Diabetes will be deconsolidated. And then on the CAS side, we'll start seeing the shift between the capital equipment and the catheters, which will make that an accretive business as opposed to being dilutive.

So what you're going to see there is the 70 to 80 basis points of gross margin improvement operationally start to show up more as the mix becomes a gradually smaller and a positive effect over time. And then outside of that, we've got some external factors. So we have to contend with the tariffs. So for second half, we've got about 90% of that $185 million of tariffs that's going to show up in the income statement. The bigger portion is in Q3. And then we'll have a carryover of tariffs going into '27. And we expect foreign exchange, which is the last item there to be a slight tailwind going into '27.

So if you go -- it's a long answer, apologies, but I think it's important that you understand the algorithm. Going into '27, we'll keep investing in R&D to get to the 10% over time. But you should expect to see leverage on the SG&A line in '27. So look, we're confident that with the growth, with what we're doing from a gross margin performance in a sustainable fashion and COGS and pricing and the leverage on the overhead, we'll have a leverage P&L on the operating profit line in 2027. And that's why we hold on our commitment to have high single-digit EPS growth going into next year.

Yes. And just to add to that, there's more oxygen here to create for the investment. It's good to see the improved pricing. And as we go forward, we're not assuming much incremental, but -- pricing, but at least holding the improved position that we have. But there's more oxygen in our cost down. As we -- there's opportunities in scrap, obsolescence and over time, continue to optimize our network. So these are areas, I think there's incremental opportunity and cost down. And Rob, I've read some of your stuff in the past that you don't think there's much to do for us on SG&A, but there's more. There's more to go on SG&A for the company, and that's where the scale of the company should benefit us here. And it's not going to be easy on the company, but there's opportunities there, and we're committed to doing what it takes to fund these growth drivers because what we're seeing out there with patients on these different growth drivers and what we're hearing from clinicians, the impact on them and their staff, it's -- this is a big opportunity for the company we haven't seen in decades, and we're going to make it happen, right? And so there's still room to go on SG&A as well, and like I said, COGS to make this happen.

Great. That was a fantastic answer. Maybe just 1 quick follow-up. Jeff and Thierry, I know even since the beginning of this year, you've talked more and more about tuck-in M&A. How are you thinking about the environment today? Do you see a lot of opportunities? And any areas you see more interesting than others to help flesh out the portfolio?

Yes. No, look, we're very focused on the tuck-in M&A. I don't want to tip our hat in terms of exact segments. But we definitely are prioritizing some of the -- again, it's tuck-in. It's -- we're prioritizing these higher-growth segments. A lot of that is in cardiology, some in neuroscience as well. We like that Affera profile, right, where you're close to market or just you're on the market early stage or close to market would be ideal. Not afraid to make the investment that it takes to get those type of companies. But as Thierry said on the -- on your earlier question on like where is the R&D going, doesn't -- the tuck-in M&A, I wouldn't rule out some of our other key franchises that may need to augment their R&D with a little M&A. But we are more focused on these higher growth segments. And then the Board committees we've set up help with the speed and enable us to move faster. So we'll see where it goes, but it's definitely a big focus.

One thing that we don't communicate at all about it, but we've got a pretty active ventures and that arm has been pretty active. So it's got over 50 companies in which we have a stake right now. And we like to use that arm to make investments in sort of early stage companies. And it helps with some of the dilution, et cetera. And typically, we always make these venture investments with a view of going higher into the capital over time. So it's never a venture for venture. And again, it's been -- the pipeline there is pretty strong, and we'll keep working that angle too, because it's helpful to feed the pipeline for future M&A.

Yes.

Thank you, Robbie. Looking at the clock here. I think we've got time for about 3 more questions. So next, we'll go to the line of Larry Biegelsen at Wells Fargo Securities.

Congrats on a nice print here. So Geoff, I wanted to ask about the ramp of Ardian because as you said, it's a question of how fast. So I'm hoping you can add some precision to your earlier comments. I think at our conference in September, I asked if U.S. already in sales could replicate the U.S. WATCHMAN ramp, which is about $400 million in year 5. And I believe you said you'd be disappointed if your U.S. Ardian sales didn't achieve $400 million by, I believe, year 3. So how does the exclusion of isolated systolic hypertension in the NCD impact how you think about the ramp? And do you still believe you can achieve $400 million U.S. sales by around fiscal 2028, which I think would be year? 3. And just confirm, Jeff, that the current run rate in the U.S. is about $50 million?

Well, look, let me start by saying, yes, I would be disappointed if we're at year 5, whatever you said at $400 million, we think it would go faster than that. And this -- the final NCD won't hold us back. And like I said, we believe it's an improvement on the proposed NCD. Maybe this is a good time because I know there was -- on that NCD, like I said, it's an improvement to the proposed NCD. And if you go back a year, it's better than what we thought a year ago. If you go back 5 years and you asked us if we thought we would get this type of NCD, we'd say that's the best case scenario. So this market, like I said, is as big as we said it's going to be. And we believe that this final NCD, as you dig into it and really understand how hypertension today is treated, it actually reduces the requirements for patients to get this therapy and it reduces the time. And this is a good time that we have our Chief Scientific and Medical Officer on the line, knowing that there'd be Dr. Laura Mauri, who's also an interventional cardiologist, knowing that there'll be maybe some questions on this on the treatment pathways. Maybe I'll ask Laura to comment since you mentioned that 1 systolic question, our diastolic question. Laura, can you maybe provide some context here?

Sure. Larry, specific to your question about isolated systolic hypertension, those are patients who don't have an elevation of their diastolic or the lower number of their blood pressure. It's only the top one. And Jeff, we're continuing to study those patients. But I think the important thing to note is that this population is actually pretty small for us overall. If you look at recent studies, people with hypertension over age 60, it's less than 15% of patients who have ISH or this condition. And for patients who are younger than 60 who are half of our patients in trials and then also in practice, it's really very unusual. So as Geoff said, out the gate with the NCD, if you just look at that topic, we would estimate that would be less than 10% that would be affected by systolic systolic hypertension or not meet those criteria. And then overall, just to reiterate what Jeff said is that the overall the final NCD makes access more practical for patients with less time delays to treatment, less restrictions and the couple of things that they've talked about screening for are really things that are done in standard practice by general practitioners or internists.

And I think the other part just to mention is that in their response, CMS really reiterated that quality of life is a really important consideration for patients because lifestyle changes and being on many medications can be really difficult. And so they specifically said the good pave attempts are reasonable before referral rather than specifying some like mandatory minimum doses or number of medications. So overall, whether it's ISH or overall, the workflow for patients to get into referral for simplicity is really not restricted.

next, we'll go to the line of Shagun Singh at RBC Capital Markets.

Great. I wanted to touch on the financial algorithm. Other key message was growth acceleration. How should we think about the base business? Is it mid-single digits? The $1 billion incremental PFA sales is about 300 basis points? And then Ardian, I don't know if you could put a final point there in terms of the growth contribution. But as you think about growth acceleration, should we think about Medtronic moving towards that high single-digit on the top line?

And then on portfolio management, I was just wondering how you're thinking about or should we expect portfolio pruning beyond Diabetes?

Well, maybe -- Shagun, thanks for the question. I'll start with the last part of it on the portfolio management. And look, this is an ongoing focus for the company. And it's really making sure that beyond Diabetes, right? First of all, that deal is tracking and it's on track and going well. But beyond diabetes, we just want to make sure that the whole portfolio fits together, we're getting the right amount of synergies, and we can provide the right amount of focus on these generational enterprise growth drivers like PFA, like Ardian and like Altaviva and Hugo when it comes to the U.S. and others.

And so it's still -- it's -- it remains a focus and it remains a focus of like one of the board committees that we set up, and we're meeting frequently on this and looking at it. And that's what I'll say there. And then I'll have Thierry answer...

Look, overall, if you think about the guidance that we just gave 5.5% on the full year, we were at 5.2% at the end of the first half, we're guiding at 5.5% in the third quarter. So you can do the math for what fourth quarter looks like. And we don't want to slow down from there. And look, what I would say is, it's pretty clear that CAS represents a sizable opportunity. We reiterate the incremental $1 billion coming shortly, probably in the beginning of '27, fiscal year '27 for us. And Ardian, we have all these discussions about the speed, et cetera, but I think it's important to keep in mind that 1% of market share in that population is sort of almost $3 billion of revenue for us. So it's a pretty significant opportunity. And we talked about the size of the Altaviva opportunity as well. It's 20 million patients overall.

So those come in increment to the rest of the business and the rest of the business is not standing still. So Specialty Therapies is getting better. You saw a first sign in this quarter and it's going to keep going. With the product activity that we've got in neurovascular, with Altaviva and Pelvic. And the key franchises, look, had a great quarter. It's going to continue to perform for the rest of the year and beyond. We're investing in that business to keep the technology lead. So we don't intend to go backwards. CST Has been improving on the back of the AiBLE ecosystem that the team has created.

So look, we're positive about the opportunities of the company going forward, and we'll keep you posted when we give when we give next year's guidance at the end of Q4.

We've got time for 1 more question, and I apologize to the analysts that we weren't able to get to. If you've got additional questions, feel free to reach out to me during the day. So we'll go to our last question, Pito Chickering from Deutsche Bank.

I have sort of 2 product questions. I'll ask them upfront. The first 1 is, as [indiscernible] move into the ASC setting, can you talk about how you are positioned in ASC in terms of mappers and Affera placements? And on TAVR, can you talk about what you saw in the U.S., Europe and Japan and how market share is looking in those markets?

Well, thanks, Poto. Look, for PFA and ASCs, over time, we do see that as an incremental opportunity for market expansion there. There will be a bit of a shift outside of the tertiary centers to the ASCs over time, but it also be a market expansion opportunity for us. It is a focus for us. We have been hiring across the company, quite frankly, particularly in Neuroscience and in Cardiovascular, folks that are specifically focused on market development in the ASCs for us and what our strategy is and how our product portfolio fits there and the resources we need, including mappers. So this is definitely is in the calculus for Medtronic, not just our Cardiac Ablation business. Like I said, this -- I think this represent an incremental growth opportunity for us there.

And then on TAVR, what I'll say is we had a decent Q2 here, growing high single digits on a global basis. Internationally, we're executing particularly well and getting more than our fair share of that Boston exit. As we move forward in PFA, I think Q3, we may see a deceleration there in TAVR.

In TAVR.

What did I say?

PFA.

I'm sorry. PFA is going to keep it going, I'm sorry. But in TAVR, a little bit of a deceleration in Q3, but then it will pop back up in Q4. We've seen due to a phasing. We've seen this in prior quarters as well. I don't know if you want to add anything to that?

No. No, that's right. We saw the Q4, Q1 effect and looks kind of similar a little bit slower in Q3, but with a pickup in the fourth quarter.

And just for clarity, PFA will continue to grow off the 71%, and it will accelerate in Q3 and beyond.

Jeff, if you want to go ahead with your closing remarks.

Sure. Well, so thank you for joining all your thoughtful questions this morning. And like Ryan said, apologize to the analysts we didn't get to -- we certainly appreciate your support and your interest in Medtronic. Please join us again for our Q3 earnings broadcast for more updates and there'll be more and our continued progress and on the long-term strategies. And we expect to hold this on Tuesday, February 17. And for those of you in the U.S. I wish you and your families a very happy Thanksgiving next week. I can't believe Thanksgiving is next week. With that, enjoy the rest of your day. Thank you.