Boston Scientific Corporation ($BSX)

Good evening, and welcome to the Boston Scientific American College of Cardiology Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Lauren Tengler, Vice President, Investor Relations. Please go ahead.

Thanks, Drew. Thanks to everyone for joining us. With me to discuss our CHAMPION-AF and HI-PEITHO trials are Dr. Ken Stein, our Chief Medical Officer; Dr. Michael Jaff, Chief Medical Officer, Vascular Therapies; and Dr. Brad Sutton, Chief Medical Officer, AF Solutions. During the Q&A session, Dr. Stein, Dr. Jaff and Dr. Sutton will be joined by Dr. Marty Leon, Study Co-Chair, Mallah Professor of Cardiology, Chief Innovation Officer and Director, Cardiovascular Data Science Center, Columbia University Medical Center. We issued 2 press releases earlier today of the data presentation of each HI-PEITHO and CHAMPION-AF clinical trials. The releases can be found on the Investor Relations section of our website. This call contains forward-looking statements regarding, among other things, our financial performance, business plans, clinical trials and product performance and development. These statements are based on our current beliefs using information available to us as today's date and are not intended to be guarantees of future events or performance. In our underlying -- if our underlying assumptions turn out to be incorrect or certain risks or uncertainties materialize, actual results could vary materially from those projected by the forward-looking statements. Factors that may cause such differences are discussed in our periodic reports and other filings with the SEC, including Risk Factors section of our most recent annual report on Form 10-K. Boston Scientific disclaims any intention or obligation to update these forward-looking statements, except as required by law. In addition, this call does not constitute an offer to sell or the solicitation of any offer to buy any securities or solicitation of any vote or approval in connection with the proposed transaction with Penumbra. Boston Scientific has filed the SEC a registration statement on Form S-4 containing a proxy statement of Penumbra and a prospectus of Boston Scientific that contains important information about Penumbra, Boston Scientific, the proposed transaction and related matters. At this point, I'll turn it over to Ken.

Thank you, Lauren. Yes, welcome. Good evening. This is obviously a very exciting time for us, presented 2 very high-quality randomized trials, both of which have the potential to be practice transforming. Before we get into those, I want to begin just a high-level overview of where we stand right now with our cardiovascular group. The group as a whole delivers today therapies that treat millions of patients every year. And if you look at what's in development, we're working on therapies that have the potential to address disease states that affect over 1 billion people globally. I also want to remind you, we recently did change our reporting lines. I hope it's not confusing to everyone. Right now, our Cardiovascular group as a whole, which is led by Joe Fitzgerald, includes our Interventional Cardiology and Vascular Therapies group, which now term ICVT. So that includes vascular therapies and Interventional Cardiology. Separately, our Interventional Oncology and Embolization group and then Cardiac Rhythm Management Diagnostics and our Electrophysiology and WATCHMAN divisions, which now fall under our AF Solutions group led by Nick. Before we get to the 2 trials that you all want to hear us talk about today, I just want to reiterate the overall strength of our clinical trial portfolio. I do believe it's one of the factors that differentiates Boston Scientific from the competition. I was talking to folks earlier today. Someone told me 10 years ago, we'd have 2 papers in the same issue in New England Journal of Medicine. I'd have said you're crazy. But that's not all that's going on. And so just a quick look at what's to come in terms of more important clinical trials. I'll begin our FRACTURE trial. That's the IDE trial to get SEISMIQ approved within coronary use. We will be presenting that at the EuroPCR meeting in few weeks, AVANT GUARD, our randomized clinical trial of FARAPULSE as first-line therapy for patients with persistent atrial fibrillation will be presented as a late-breaking clinical trial at the Heart Rhythm Society. And then down the road, but I think very important to make sure we all focus on THRIVE trial to get TIVUS through its IDE approval for treatment of hypertension, AGENT DCB stance, a very important indication expansion trial for the AGENT Drug-Coated Balloon and further out our expected VITALYST high-risk PCI trial, which we still do hope to begin at some point this year. But that's not what you all are here to talk about tonight. So with no other ado, I'm going to turn things over to Dr. Michael Jaff.

Thank you, Ken. What a great day for patients with PE, incredibly exciting day. This one doesn't work. Thank you. As of yesterday, patients who came into an emergency room or faced in a hospital with sick symptoms of a pulmonary embolus were largely managed by a watchful waiting on monitored bed and anticoagulation. And if things went well, they went well. And if things went poorly, they dealt with it. And oftentimes, they dealt with it was a very complex series of events. As of today, that's no longer the case. HI-PEITHO was a large prospective multicenter international randomized clinical trial with meaningful clinical endpoints and independent adjudication of all those endpoints. 544 patients with intermediate risk pulmonary embolus, 59 sites, U.S. and 8 countries in Europe. Half were randomized to EKOS plus anticoagulation that is ultrasound-assisted catheter-directed thrombolysis and half randomized to anticoagulation alone. The primary outcome was the 7-day composite of meaningful clinical endpoints, death from a pulmonary embolus, recurrence of a pulmonary embolus, which in every study has shown a bad prognosis or the risk for cardiovascular decompensation or collapse. All of those endpoints were independently adjudicated. This was the primary outcome statistically P of 0.005 in favor of EKOS plus anticoagulation over anticoagulation alone. This is a dramatic difference. One of the big knocks on thrombolytic therapy and EKOS in the past has been that sure it may work, but you do it at the expense of major bleeding and catastrophic intracranial hemorrhage. And in the HI-PEITHO trial, there was no difference in major bleeding at 7 days and 30 days regardless of the definition, ISTH or GUSTO. In addition, there was not a single intracranial hemorrhage in this trial. So we are incredibly proud of this. The feedback we've heard so far has been incredible. And with that, I will turn it over to Brad to talk about CHAMPION.

Thanks, Dr. Jaff. Good evening, everybody. It's a full house. It's a long day for everybody, I think. We're going to talk about CHAMPION-AF. And so I'm going to put on my sort of clinician hat a little bit and talk about -- think back to the days when I treated a lot of atrial fibrillation, albeit in the stone age before pulse field ablation. But nonetheless, this is an incredible undertaking. The disease state is well known to you all. More than 60 million patients have this disease globally. It comes with a fivefold risk -- increased risk of stroke. And we know that the mainstay of therapy here has been long-term oral anticoagulation. That comes with a couple of problems. Number one, something like 40% or more patients don't tolerate the medication or take the medication as prescribed long term, which comes along with an increased risk of stroke. And of course, oral anticoagulants come with the risk of bleeding. So the CHAMPION-AF clinical trial is the largest prospective randomized trial in this space. It's the second large randomized trial we've run in this space relative to novel oral anticoagulants, 141 sites globally and 300 operators. So a really broad experience of operators enrolling in this trial. CHA2DS2-VASc 2 or greater in men, 3 or greater in women and randomized to WATCHMAN FLX, and they could be on either DAPT or NOAC plus/minus aspirin therapy for 3 months. What we're going to talk today about, as you saw from Dr. Kar's excellent presentation is the 3-year data. So here, you can see that we met our prespecified primary efficacy endpoint, the noninferiority endpoint, which was a composite of cardiovascular death, stroke, systemic embolism. I would point out a couple of things. Number one, if you look at the curves, they diverge, converge and diverge and converge a number of times. I think this is a function of the overall low event rates. And I would point out here that the absolute sort of difference on an annualized basis between these 2 therapies with regards to ischemic stroke was 0.33%, right? So significant for noninferiority and incredibly low event rates in both arms, suggesting that both therapies are reasonable for patients looking to reduce the risk of stroke in the setting of non-valvular atrial fibrillation. The primary safety endpoint here was the composite of nonprocedural bleeding, both major bleeds and clinically relevant nonmajor bleeds. So let's talk for a minute about what is a clinically relevant nonmajor bleed. These are not nuisance bleeds. This is not bruising. This is not an annoyance. These are significant bleeds that impact patients' lives. They require an escalation of medical care. They require an emergency room visit or a change in medication. So these are meaningful to patients, and we showed superiority with the appendage closure group over the oral anticoagulation group. Now procedural bleeding was not included in the primary safety endpoint, but we did look at it in a secondary analysis. And this is an important slide for you to sort of take in. The benefit remains true when you include procedural bleeding with a 34% relative risk reduction in bleeding over 3 years relative to oral anticoagulation therapy. And it's a [indiscernible] slide. A number of secondary endpoints, prespecified secondary endpoints underscore the safety and net clinical benefit of WATCHMAN FLX. First, on the left is the noninferiority endpoint around major bleeds. So this is both procedural and nonprocedural bleeds, so no difference there. The net clinical benefit, I think, is an important story. So if you're a patient or a provider, you're weighing risks and benefits of 2 therapeutic strategies. And so what you see here is the composite of cardiovascular death, stroke, systemic embolism and nonprocedural bleeding and statistical superiority in terms of the net clinical benefit for appendage closure over anticoagulation. So to put this into context, I think there's a couple of really important points to make. Again, the annualized rate of stroke here and for stroke and systemic embolism in the WATCHMAN arm was 1.1%. So how does that compare to the pivotal DOAC trials? If you look at the ARISTOTLE trial, which studied apixaban and led to apixaban approval, it's the most prescribed DOAC in the world, annualized risk of stroke of 1.3%. And in fact, this rate in the WATCHMAN arm in CHAMPION is as low as any of the pivotal DOAC trials. And I think that's an important thing to keep in mind. And that's still with an incredibly high compliance rate in the drug arm here, right? So a difference, again, of 0.33% per year between the 2 treatment strategies with an almost 90% compliance rate in the medication arm here. And we know that's not real world. So we're very proud of this data. Again, the bleeding benefit preserved both when you include procedural bleeding and with the prespecified safety endpoint. Finally, I want to just talk about the market opportunity here. Today, there are 5 million patients indicated for the therapy. We believe the CHAMPION-AF data paves the way to quadruple that number by 2030 and beyond. So 20 million indicated patients around the world. The bulk of those are in the U.S. If you take the 5 million today, it's probably 3.5 million in the U.S., 1.5 million outside of the U.S. We will be pursuing a label expansion. The goal here is to position this therapy in eligible patients as a first-line alternative to oral anticoagulation. Of course, we're seeking and working actively now with professional societies to get meaningful interim guidelines updates and ultimately expanded coverage both with regards to CMS and the commercial payers, which we believe supports our previously stated market growth of 20% over the LRP. And we're not stopping there. So this is a picture of our fourth-generation device. We're really committed to innovation in this space. This device really is uniquely architectured to close any appendage regardless of the complexity of the anatomy. I would point out that, that IDE trial kicks off later this year. We expect to commercialize that sometime in 2028. And then maybe 1 or 2 other things that I'd love to highlight here, the SIMPLIFY trial, which we hope to present the back half of this year, a reminder that, that is a 3-arm randomized study comparing on-label DAPT versus single antiplatelet therapy or half-dose DOAC. So really excited to bring that data to you all. And then we do have 3 late breakers that I'd be remiss if I don't mention at HRS coming up, actually, one around the ASAP-TOO trial, which if you've been involved in this space for a long time, you may remember. So excited to give you a little bit of data on ASAP-TOO in contraindicated patients. On the EP side, AVANT GUARD, as was mentioned by Ken, is our first-line persistent AF ablation story randomized versus antiarrhythmic medication. And there's one more, Ken, help me remember. Study of CHAMPION. Thank you. So the prior ablation segment of CHAMPION-AF versus no prior ablation will be presented as a late breaker. With that, I'll turn it back over to Lauren.

Thank you, Brad. And you did want to make the point that you couldn't have said it better yourself than Dr. Kar. So that's what you left this slide with.

That's right.

Yes.

Said it better than I did.

All right. Yes. Awesome. So I know everyone is going to ask the slides will be posted on our website at the conclusion of the event, so you'll be able to see that. We are going to open it up to Q&A for the next 20 or 25 minutes. In order for us to take as many questions as possible please limit yourself to 1 question. I will let my esteemed panel come up and sit down and just raise your hand and someone will give you -- maybe we'll start with, yes, go ahead.

Shagun Singh, RBC. I was just wondering with respect to next steps, how should we think about guideline changes, label changes? And then what impact do you expect from the study in 2026 prior to these label changes in NCD?

Maybe I'll -- just on sort of the broad picture, we think this data supports our previously provided guidance of the 20% market growth. And maybe I'll let Brad or Ken speak to the guidelines and NCD.

Yes. I mean I'll just reiterate what Brad said. Again, we do firmly believe that this data should support a label expansion. So we will be submitting to FDA for that. We are working with the societies now in terms of getting a focused update to consensus documents, which would come before any guideline update. And then once we get through the FDA process, then the next step would be to work with CMS in terms of getting expanded reimbursement through the CMS national coverage decision.

You can -- maybe in the front row over here.

Matt Miksic from Barclays. Maybe just maybe help us understand how you think about the near-term effects before we get to the point of guidelines, NCD, et cetera. What challenges, if there are challenges in the clinical referral community, do you think that this solves or helps kind of move along?

Dr. Leon, do you mind answering that?

Sure. Glad to. Well, first, guidelines tend to lag behind clinical practice. I think people are going to look at this data, hopefully, as we do, that this is a very strong endorsement for the expansion of left atrial appendage closure with the WATCHMAN FLX in a much broader population than we've previously been confined to. You know the current guidelines are pretty restricted. Right now, even in contraindicated patients, it's only a Class IIa indication. In the Class IIb indication in patients that are at moderate or high bleeding risk, which is well behind what we currently are doing clinically. And it's my feeling that these data with a 0.33% annualized increase in either ischemic strokes or systemic embolization versus about a 2.6% reduction in bleeding that -- that's going to be a balancing act that's going to allow us to be able to have meaningful conversations with patients. And given the nonadherence even to DOACs, at least in my mind, it's likely that a significant number of patients are going to prefer this single treatment option to what is currently available. Kind of interesting just to digress, and this wasn't brought up this morning, but in the NOAC group, there are about 200 patients that crossed over. And of the patients that crossed over, more than 50% were because either patients or referring doctors decided that they really wanted to have a left atrial appendage closure device and they felt necessary to indicate that, that's even before there was any data. So it gives you a sense as to what physicians and what patients feel about lifelong NOAC therapy as an option, particularly in older patients. So I think that, that's going to resonate with the community of people who have atrial fibrillation.

David Roman from Goldman Sachs. I've done a bunch of web scraping today using AI to get -- to gather all the social media feedback from different types of physicians. So I was hoping I could just read it to you and get your feedback on it. It says, EPs scientifically interested but clinically cautious. Interventionalists most bullish see near-term adoption upside and general cardiologists pragmatic gatekeepers slower to change behavior. So I guess I'd just love to get your perspective on, does any of that surprise you? And then what is the strategy to -- and what's now the go-to-market strategy that you have the data in hand here in terms of driving adoption?

Ken, do you want to start and then...

Maybe I'll start and then Marty. Well, first of all, you didn't need to go to AI to get that descriptions, just the varying personalities in the specialties. That's sort of something we've all been dealing with for 30 years. No, I know, David. I know where you're coming from. I just would say that, that's a pretty darn good description of all of us. And I think that's right. The implanted community as the people I've been talking to here, irrespective of specialty, I think, have been uniformly, I'd almost say giddy, with these results. I think these results were as good as anyone could have possibly expected in the implanted community. I think general cardiologists rightly are a little more conservative, but that's why trials like this are so important. And having the strength of a 3,000-patient randomized clinical trial that hit all of its endpoints, having it in the New England Journal of Medicine is important. I think the biggest thing that people are going to learn from this, I expect, and Marty, I'm interested in -- very interested in whether you agree or disagree with me. This trial, we felt was a very big risk when we started it because this trial enrolled a very low bleeding risk group of patients. And I think the real question was a group of patients that turned out to have an average HAS-BLED score of 1.6, could you really show superiority in bleeding? I think the biggest lesson that people are going to get here is that there is just a lot of clinically important bleeding even in people who are considered to be good candidates for the NOAC drugs.

Yes, I completely agree. I mean I think that -- I mean, there are obviously differences between how electrophysiologists and structuralists and interventionalists and general physicians view things. I think at the beginning that to a certain extent and perhaps even rightly so, the left atrial replenish closure was tainted with some early procedural complications and people were much more conservative about applying it to broader groups of patients. And I think that was not unreasonable. But that's changed. And if anything, look at the safety data in this study with over 100 sites, a global trial, a 1% overall procedural significant complication rate that is striking, and that should allay a lot of the concerns about broader application. So whenever you talk about changing indications, I think you always have to weigh some of the primary efficacy effects versus what the safety is. And the general practitioners are always going to elevate or embellish, not in a negative way, but they're going to focus on safety. I think one of the messages that we should really convey is that over a broad population of proceduralists all over the world, there's a very, very low complication rate with this current device. That is the current state of practice. And I think that's also going to drive therapy. It also builds confidence within the operators in terms of being able to expand this beyond the current indications of patients who are higher risk or being nonsuitable for anticoagulant. So...

Chris Pasquale, Nephron. Very encouraging trial overall. I was hoping you could just comment on the ischemic stroke rate. Hazard ratio was 1.61. The lower bound was right at 1. And there is a 5-year endpoint that isolates ischemic stroke and systemic embolization. Should we be thinking -- how should we think about the relative risk over time in these 2 arms? Does the device risk become ameliorated because of endothelialization of the device itself? Just anything we can take that we might be seeing in 2 years from what we saw today?

Yes. Again, maybe I'll start and then turn things over to Marty. So first, most important, point is, right, the reason that, that endpoint is a 5-year endpoint is because it's not adequately powered at 3 years. And I caution against really putting too much into it. I think second, from a patient-centric standpoint, what's more important than specific types of stroke is all stroke or all stroke and systemic embolism. And again, we, a, we very convincingly meet noninferiority for the combined endpoint of cardiovascular death, all-cause stroke, systemic embolism. But even if you do believe that there is a small difference in the ischemic stroke rate, and let's see what the 5-year data play out, the rates in both arms are incredibly low. And the difference on an annualized basis is very small relative to the potential benefit in terms of reduction of clinically meaningful bleeding. And so I think the real important message out of this then is patients ought to be able to make that decision.

Yes, 2 points that I'll make. First, we didn't show the Kaplan-Meier curves of the ischemic stroke rates, just didn't have time. I think that the way they organize the late-breaking trials was a little bit funny this year. The contextual discussion, I think, really cut away from being able to show more data and having a meaningful discussion. In any event, if you look at those Kaplan-Meier curves at the end of 3 years, the difference in ischemic strokes is 3.2% versus 2%. That begins to separate at 6 months and is pretty flat between 1 and 3 years. In fact, between 1 and 3 years, there are 27 versus 23 events. And with the difference in denominators, that's almost identical. So there isn't very much change over time as you go forward. So I think that I would keep that in mind, and I don't expect that these curves are going to continue to diverge and then we'll lose the potential of achieving noninferiority. So that's one point. Second point is we're talking about all strokes, all ischemic strokes. When you break them down into disabling versus nondisabling, about 60% of these strokes are nondisabling. Now what is a nondisabling stroke? It's a modified ranking score of 2 or more, which means that you have difficulty riding a bicycle or playing the piano. It's not a very significant stroke. It's a low bar of stroke. So what I'm saying is that the real significant strokes is even that much less. And when you weigh that against the difference in bleeding, that's a discussion I'd really like to have with patients who have difficulty adhering to anticoagulant therapy, even NOAC.

Josh Jennings from TD Cowen. You reiterated the TAM expansion opportunity. I was hoping to just review now that we know the CHAMPION data, we saw the CLOSURE-AF publication in New England Journal of Medicine last over the weekend. The discussion referenced OCEAN and ALONE and CLOSURE. I was hoping to just get a review of why you think the TAM expansion opportunity is still fully in play. I think you've talked about this in the past. So now with everything on the table, maybe it would be great to just review the impact of CLOSURE, OCEAN and ALONE.

Yes, I'll take a stab at that. I think it very much is still in play. And the way I see it, it really becomes a question of patient segmentation and directing the appropriate therapeutic strategy to the appropriate patient. OCEAN and ALONE were sort of highly selected low-risk patients who had undergone a successful ablation as proven by the fact that they were atrial fibrillation free for a year of close monitoring, right? So that is a very selected group of patients with very low CHA2DS2-VASc risk. That is not the appendage closure patient, not in this trial, not in commercial experience, not anywhere in the world. So I think there is room for both strategies depending on the risk profile of the patient. I think CLOSURE is an interesting trial. So contemporaneously, it's worth kind of point-by-point conversation. But in fact, it's a much smaller trial with a composite endpoint, less rigorous study design with old generations of devices. They screened something like 10 patients, every patient enrolled. It took years and years to get that trial complete and really failed its endpoint because of the bleeding complications very procedurally, bleeding complications that we don't see, as Dr. Leon mentioned, with the WATCHMAN FLX device. It's our belief, frankly, that if that had been run exclusively with WATCHMAN FLX, it very likely would have been a positive trial.

Yes. I have to tell you, I was really surprised that CLOSURE got published in the New England Journal of Medicine. There was a lot of buzz about it after its presentation at the AHA. When you think about it, this was meant to be a real-world pragmatic investigator-initiated study that took over 6 years to enroll a fraction of the initial patients that they really intended to enroll based upon the initial study design and with a screen failure rate of 92%. So only 8% of the patients who are actually screened and consented were actually enrolled in that trial. The procedural complications were -- the major bleeding was 5% -- was 5x what it was in CHAMPION-AF. Any potential benefit of having to stop anticoagulation was completely negated by the totally inappropriate complication rate in the first month. But with all of these caveats about CLOSURE, what was nice about CLOSURE was that the stroke rates were about the same. So in fact, we're going to do a meta-analysis, looking at ischemic stroke, we're going to include CLOSURE and we're going to include CHAMPION, we're going to include PRAGUE-17 and OPTION. And I think you'll get a much better feeling for what the actual results are. So that's a funny trial, and I'm just struck that people have really latched on to it. A very different patient population enrolled in a very different way. 46% of the patients enrolled were enrolled at 3 centers. It's a very different study. So it's a little bit hard to interpret and really put it in the context of this 3,000-patient clinical trial that was done in a much more rigorous fashion that will have 5-year follow-up with a third primary endpoint to come.

Joanne.

Joanne Wuensch. I'm curious how you think physicians are going to turn the switch on in thinking about accelerating enrolling patients. We talked earlier about that they're going to maybe wait for guideline changes and that they're a cautious group to begin with. But I'm trying to think about if I'm a doctor that usually does, I'm making this number up, 20 LAACs a month, do I think in 2027, that's going to 30? I mean I'm trying to think about how that changes the vision of not '26, but in '27 plus that. And Lauren, this then becomes a question for you. You reiterated the WATCHMAN growth rate of 20% in the LRP, but that was before we knew the results of CHAMPION. What does it take for you to say it's higher than that?

Do you want me to start?

Lauren, you go first?

All right. Yes. So as we've discussed, we've always assumed that data from CHAMPION will be positive as it was necessary to continue to expand the patient population for which we'll treat to support that 20% growth rate. So the data was positive, and we see it as supporting that overall market growth of 20%. I'll hand it back to the CMOs to answer the hard stuff.

Yes. Well, again, I guess you can do the math on the 20% and then answer your average one is doing -- and thank you for doing the 20 months, by the way. We appreciate it. But well, 20 would be going to 20 x 1.2, right? So I think maybe the deeper part behind the question, right, is again, we see this as helping sustain that 20% this year because I think as we've said before, it does reinforce the current indication. Nearly half of the patients in this trial had an ablation within the prior year. So I think it also helps reinforce the concomitant indication and referrals for that. I think, again, Marty was very eloquent talking about the safety profile, which is really very gratifying to me given just how many centers there were and how many operators were involved in this trial. I think that also helps reinforce current referral pathway. But then it will take better representation in guidelines consensus statements. It will take a redo of the NCD in the U.S. to unlock the larger opportunity for growth. And likewise, outside of the United States, where, again, physicians, I think, are a lot more conditioned to adhere a little more closely to guidelines and where reimbursement challenges are greater than they are in the U.S., it will take the time for those things to play through in the international markets.

Great. Next question, go to Pito.

Pito Chickering, Deutsche Bank. Looking at the primary endpoints in the subgroup analysis, it looks like the U.S. is better for NOAC. Japan was a lot better for WATCHMAN and Europe is right in the middle. I know there's only about like 120 people enrolled in Japan, but should we read anything into the geographic differences between that subgroup analysis?

Yes, I can jump into that. That -- and I don't recall that, that actually reached statistical significance. It was near. It didn't. It was close. Yes. But there are plausible physiologic reasons to think that Japanese patients and East Asian patients in general are more prone to bleeding risk on anticoagulants, including the NOACs than is a Western population. And so it makes sense from first principles to think that the Japanese patients would have the greatest benefit in terms of reduction in bleeding events and being able to avoid NOACs.

All right. Next question, Larry.

Right. So maybe a 2-parter. The label and the NCD, how confident are you that FDA and CMS isn't going to want the 5-year data? And you always expected CHAMPION to help with international. Ken, you just mentioned it. Does CLOSURE-AF make that a little tougher given it's a German study?

Yes. I mean we wouldn't be submitting this to FDA if we didn't believe that the data support getting the label update. And again, once we get the label update, it is our belief that the data would support reopening the NCD and broadening the indication. And our hope would be that whatever they do come out with in -- the NCD would cover the full label. Yes, I mean, CLOSURE, is it going to have more of an impact in Germany? We're very glad that it's finally published. I think on the one hand, there's certainly more awareness about it now that it's been published than there was after it had initially just been presented at AHA. I want to come back again to what Marty said. I mean I say I'm not here to bury CLOSURE. I think there's a lot to praise in CLOSURE. And the 2 points, and I think it's on us and on the implanters of WATCHMAN in the community to get this message across are, right, number one, exactly identical stroke rates in a very high-risk population so that there are now 4 high-quality trials randomizing left atrial appendage closure against the NOACs, all showing noninferiority for stroke, and that's PRAGUE-17, OPTION, CLOSURE and now CHAMPION. And second, that, that trial failed because they had procedural complication rates and early bleeding rates that are not characteristics of what we see today with contemporary devices.

All right. We have time for one more question.

Anthony, Mizuho. Maybe can you review, you had 85% adherence to NOAC, what is the real-world adherence to NOAC? And I think the average cost is $500 out of pocket for a Medicare population. I think when you present WATCHMAN, it's going to be 0. So when you consider the low adherence plus the cost benefit of WATCHMAN, how is that going to be presented by Boston now that this data is out there?

Yes, I can take a crack at that. I mean I think it's an incredibly high rate of medication adherence in this trial. I mean kudos to the investigators and their interactions with their patients. The real-world data is not that, right? The real-world data is something more like 60% compliance. And so I think what you've got in the trial in the control arm here is really a best case scenario for clinical outcomes with DOACs. I forget the second part of your question, sorry.

Cost.

Yes, the cost-effectiveness analyses in this space have always really fallen in favor of a onetime procedure versus a lifelong anticoagulant. I think you've got an evolving landscape with DOACs becoming generic, but also the introduction potentially of Factor XI inhibitors. So I think it's a little bit of a nuanced answer moving forward. But to be sure, cost is one of the reasons patients have difficulty with long-term adherence to the DOACs.

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Please note, a recording will be available in 1 hour by dialing 1 (877) 344-7529 or 1 (412) 317-0088 using replay code 8626162 until April 4, 2026, at 11:59 p.m. Eastern Time. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.