We're good to go. Okay, good morning. Welcome, everybody. Day two of the Wolf Research Healthcare Conference. Pleased to start the day in this session with Boston Scientific. From the company, we have Chief Medical Officer Dr. Ken Stein and Head of Investor Relations Lauren Tengler. Ken and Lauren, thank you for being here. Welcome. Thanks, Mike. I look forward to the discussion. We have a lot to get through. For those that don't know, Dr. Stein is an electrophysiologist. We are going to start our discussion focused on key growth drivers, Watchman, and the ablation portfolio. If we have time, we are also going to get to the broader Boston story on innovation. With that set up, Dr. Stein, weekend before last, I was a little worked up. AHA, some data. Specifically, I want to start with this closure trial. It was a negative trial for LAAC. The device arm did not meet non-inferiority to best medical therapy. I want to get your top perspective. What are the major caveats of this study? Why don't you think this is going to influence real-world practice? Yeah, thanks, Mike. AHA, a lot of good data, some data that's less good. Let's talk about closure. I want to talk about, as you say, the caveats in interpreting it. I also don't want to lose sight of the fact that there was one piece of really good news in closure sort of buried in it. I want to excavate that at the end. Closure failed to meet non-inferiority in a very high-risk patient population that was treated over a very long time in Germany with some very old devices. Closure failed not because the device didn't prevent stroke, and I'll come back to that. It failed because there was an extraordinarily high rate of procedural-related complications and early bleeding with left atrial appendage closure. Now, really important to note that I just said with left atrial appendage closure. I didn't say with Watchman Flex. Only half of the devices in this trial were Watchman devices. The other half, some of our competitors' devices, including first-generation as well as second-generation Amulet, including Ombre. These are devices that are known to have a higher risk of postoperative bleeding specifically than Watchman Flex. And even with the Watchman devices, many, if not most of them, were early-generation Watchman and not Watchman Flex. We're just going on the presentation. It hasn't been published yet. But my take from the presentation is that if they had used Watchman Flex and if they had had the rate of postoperative complications that we see in the real world with Watchman Flex, that actually would very easily have met non-inferiority. Second thing to pay attention to, because the time over which this trial was done, a huge amount of the patients in the trial were treated postoperatively with a medical regimen that's called dual antiplatelet therapy. More recently, again, very clear evidence that that postoperative regimen is also associated with worse outcomes, with more bleeding than when patients get covered with one of the novel Oral anticoagulants for that short postoperative period. Again, if not for that and postoperative complications, we feel very comfortable that this device would have, this trial would have hit its endpoint. I want to come back to where I started. What's the good news to excavate from this? I think really one of the first times in a randomized trial in an extraordinarily high-risk population, even using some of these legacy devices, there was an equivalent rate of ischemic stroke comparing left atrial appendage closure to best available medical therapy. That's something that the critics of Watchman have never, ever acknowledged. We've seen that now in multiple other data sources, real-world data, things like PROG-17, things like the option trial to show it in this high-risk population. Actually, I think it's actually a really extraordinary positive. Good color. I'm going to follow up on PROG-17. Also a mixed device trial. Also, we believe used a lot of DAPT post-procedurally. This produced outcomes for LAAC that were much more flattering, almost opposite to what you see in closure, now slightly lower risk profile in PROG. How do you bridge that to closure? What operator inexperience in closure? Or can't tell yet because the manuscript isn't published. Manuscript's not. I do not want to pin it on the operators. The higher risk population you are treating, the higher the likelihood that you are going to have these postoperative complications, bleeding, etc. I think that that is probably the most likely explanation for the difference between that and some of the other trials. Okay. We're going to move to the, it was OSHN at AHA, and then I'm going to drag in Alone. I think they're thematically similar. My worries aren't as high on this. It seems to be a lower risk population for sure. Just remind the audience kind of why no drug or drug light post a successful ablation is not a strategy that meaningfully impairs the Watchman growth vision. Yeah, I was right. Not only do I not worry about these trials, I love these trials. I think they're fantastic news for patients. I've had a trial fibrillation. I've had an ablation, so they are pertinent to me. I think they're also really good news for us as a company because I think they're helpful for our diagnostics division and certainly for our EP ablation division. I have no concern at all that they're going to impair our ability to get that consistent double-digit growth for Watchman. Why? What both of these trials showed, I think pretty conclusively, is that if you have a low-risk patient population and they undergo Catheter ablation for atrial fibrillation and they go at least a year after the ablation and don't have a recurrence, they are at very low risk of stroke and probably don't need any long-term anti-stroke strategy. The two big caveats there are, these are very low-risk patient population. A third of the patients in OSHN had a CHA2DS2-VASc score. That's the risk score we use in evaluating whether patients need therapy of one. Those patients have never, ever had an indication for lifelong anticoagulation post AFA ablation. In fact, the OSHN strategy for those patients, a third of the patients in the trial, is more conservative than what docs were doing pre-OSHN because you would just stop anticoagulation two months after the ablation in those patients. Another third of those patients, CHA2DS2-VASc score of two. These are not the patients who are getting Watchman today. If you look at the option trial, the average CHA2DS2-VASc score in option is 3.5. If you look at our real-world data with Watchman, you see average CHA2DS2-VASc score of 4.5. These are not the ones and the twos. We really saw no impact on Watchman growth after the publication of Alone AF. Remind everyone, that came out in August of this year. Do not expect to see any impact. What it does do is it gives patients another reason to come in and get AF ablation in the first place. When I was in practice, which is pretty much a stone's throw from here, half of the patients who would come into my office asking about ablation wanted the ablation solely because they wanted to be able to come off their anticoagulants. I just always had to say to them, well, I understand that you hate these medicines. They are awful to take over the long term. I cannot tell you that just having the ablation would enable you to do that. Now, if you are at low risk, I can say that. We see this as sustaining the high growth in EP that we laid out at our investors' day a couple of months ago. We see this as sustaining the growth of our diagnostics franchise as you look now at a real reason to have to monitor these patients, make sure they're not having recurrences of AF, but really do not see any reason to worry about an impact on the growth of Watchman, whether it's concomitant procedures or standalone. That's good. That was a complete response. I'm going to avoid the follow-up here. In the interest of time, there's a lot to get to. Let's go to Champion. Easy first one. Do we have a date yet? First half of 2026, aiming to present it at one of the major scientific conferences in that timeline. This would be AF Symposium in February, ACC March, HRS in April would be my three candidates as. Zero three. Okay. All right. We will stay tuned. I think the recent message on Champion, I feel like, has emphasized we're really encouraged by the contemporary real-world data we're seeing in Watchman. Every reason to believe this is a successful trial. The shift to the focus has turned towards kind of commercial real-world uptake. I feel like the company has emphasized a little bit more, well, we'll also need some reimbursement frameworks adjusted, guidelines changed. As I watch med tech, I feel like doctors move ahead of formalities all of the time, or maybe not all of the time, often. This feels like one of those situations. Maybe what needs to happen here on the reimbursement and guidelines front that is important for the next wave of Watchman? Do you really think that this is something where data turns over, practice doesn't adjust until those formalities do? Yeah. There are a couple of things that will come into play should Champion be positive. Obviously, we do not know. We are so blinded to the results. Let me maybe break out three different effects that a positive Champion could have that, again, enable that sustained market growth that we have talked about. One is just reinforcing confidence in the current indication. There are devices still underpenetrated into the current use case as second-line therapy. There are plenty of people who are enthusiastic about it. There are still some of these boo birds on the sidelines. I think a positive Champion helps bring that in. In the U.S., perhaps as important internationally, where use is much more restricted today than it is in the United States. That is the sort of effect that you can see, again, relatively quickly ahead of anything else. The getting into the first-line use case, which is really what Champion's studying, is this a first-line alternative to best available medical therapy? That would require a change in the label for us to be able to promote it, would require a change in the U.S. to reimbursement. This is governed by a national coverage determination under Medicare. You really can't do that in the U.S. today and get reimbursed for Medicare. Docs will do a lot of things off-label, but not things you don't get paid for. Yeah. Maybe I can give a little bit more on just the logistics of that. We like the approach because it does give us a sustained 20% Grower in that Watchman business. Just for logistics and for our proxy, it took us about seven or eight months to update the label on Watchman with the option data. Once we have that label update, we can go to CMS and ask for the NCD to be opened up. They have up to 12 months to rule on that. That is sort of the timeline that we are talking about. Only clinical data so far. Let's go to numbers. Watchman is accelerating. After all that, sorry, but the market likes to look ahead. Love it. Watchman is clearly accelerating in the U.S. The message has been this is concomitant on the heels of option primarily. My question is, what do you think is really going on? Kind of is it simply the high risk for stroke ablation patients are now being offered Watchman two for one? You think that is kind of really what's revitalizing the rate of growth, or is it something else? Yeah, I prefer vitalizing to revitalizing. I don't know that it needed to be revitalized. Okay. Okay. Okay. Fair enough. Yeah. I mean, certainly huge growth in the concomitant procedures since the publication of option and concurrently with that publication, getting good CMS coverage for those procedures in the hospital. Lauren, remind me, what proportion of our Watchman implants today are concomitant? Exiting 2025, it'll be 25%. Yeah. I think it is pulling in patients who otherwise would not have been referred for Watchman very clearly. Again, when we look at our data pre-option, about 10% of Watchman patients had an ablation within a year of the Watchman procedure. I think it's really clear that these are patients who are not immediately planned to have a Watchman. There is also an interesting other phenomenon, which is as much as it's helping to continue to vitalize Watchman growth, it's also part of the story of the ablation growth because we're also seeing patients who are getting referred in for Watchman where the EP is saying, as long as we're going to do the procedure now with something that's as safe and effective and predictable as FARAPulse, let's also give a try at ablation where I think in previous years, you would have just gone ahead and done the Watchman and not had the attempted ablation. Just for numbers, Mike, maybe so there were 4 million patients indicated under the original NCD for Watchman globally. Roughly 50% of those are in the U.S. With Option, you have got another 1-2 million more patients now indicated for Watchman. Again, roughly half of those are in the U.S. One other stat that I find really helpful because we get asked a lot around what can concomitant get to. Just recall in the U.S., 60%-65% of procedures are done by the EP who also do ablations. The rest are done by ICs who just do Watchman and do not do ablations. It sounds bidirectional. If you were to hazard a guess, is Watchman better enabling ablation, or is the ablation flow opening up Watchman, or difficult to tease out? Yeah, I don't know. Again, I think it's bidirectional. It's FARAPulse enables you to do more of these concomitant, we're calling FARAWatch procedures. Not Voltlet. No. We'll do that. Not yet. Not yet. Not Voltlet. No, no, no. We're not. I came up with that on the walk to the office today. It's a very diminutive term when you think about it. No, so it goes both ways. Again, it's Flex, FlexPro, the predictability and safety profile of that device, the unique data that we've got with Flex from option, but also FARAPulse. I think in an earlier world, if this was an RF ablation taking a couple of hours with a variety of risks, and if this was earlier generation devices, a little more complicated to use, you would not see the kind of growth that we see today. All right. Let's go to PFA. The company's described PFA penetration globally, 50%. My team and I, we're trying to figure out the U.S. Where are we? Our best guess is it's going to be above that, maybe 60%. I think it's important for folks to understand your denominator here excludes redos. I think that's an interesting confirmation just for market penetration. Is that right, Lauren? Yeah. We don't have indication for redos. This 400,000 US AF ablation number that has been recently cited, that's a de novo estimate. Yep. Okay. I think, Dr. Stein, the question for you is, one, do you agree that the U.S. is maybe in 2025 a little bit higher than this kind of global 50%? Absolutely. Tour us around the different use cases, kind of de novo paroxysmal, de novo persistent, some of the off-label stuff. What are you seeing in terms of use rates across all the different types of patients for FARAPulse today? Yeah. Again, we're seeing a high degree of use for FARAPulse, both de novo paroxysmal, which was our initial labeled indication, and de novo persistent AF. Part of that is the Catheter is just really beautifully designed, both for doing pulmonary vein isolation, which is the standard of care today for paroxysmal AFib, and posterior wall isolation in addition to PVI, which has become the standard of care now for persistent AFib. Actually, we're seeing a striking amount of posterior wall isolation even in the paroxysmal population today. Historically, the market has broken down, call it roughly two-thirds of cases being de novo ablation, roughly a third being redo. We are studying the combination of FARAWave Catheter and our point Catheter, FARAPoint. We pay people to name these things. FARAPoint in redo patients in a trial called REMATCH, I think the redo population is important. It's also part of the reason that we acquired an AF mapping company called Cortex that actually uses an AI-based technique to identify AF sources that we think may be particularly useful in a tough redo patient. We recently began enrollment in our, that device is FDA cleared already. The data are pretty scanty at this point. We did recently begin enrollment in a large-scale randomized trial to again convince everyone of the utility of that technique. What I do want to emphasize, though, because I do not know that the community recognizes it, is that two-thirds, one-third breakdown is historic at this point. When we look at our data with FARAPulse, our published clinical trials, and our real-world evidence, we are down to single-digit level redo rates when people get their de novo ablation. I also do think that it's predictable that the market is going to switch from this two-thirds, one-third to a mix that's much more heavily weighted by de novo. In some ways, very similar to what happened with coronary intervention a couple of decades ago with the introduction of stents and then drug-eluting stents where you went from these very high redo rates with plain old balloon Angioplasty now to very low redo rates with coronary intervention. I'd expect we're going to see something similar with AF ablation. Is that single-digit rate something measured out one year in your internal data? That's measured one year. Okay. Helpful. How about mapping? Opal is one of the growth drivers here. Historically, Boston Scientific hasn't had much share, if any, in mapping. Two large incumbents that are holding on and navigating the shift to PF on the ablation Catheter side for now. Why will Opal win now? Yeah. I think Opal is becoming an incredibly competitive system. It does offer some unique advantages versus either the incumbent mapping systems. First off, it is the first system that really was purpose-built around PFA and purpose-built around FARAWave. It does give much better Catheter visualization than either the competitors that are on the market. It does give the ability to actually understand where the PFA energy is going to intersect tissue. We have what we call field tags. Docs, before they give the energy delivery, really know that they're going to be ablating in the area exactly where they want. Our latest software release adds contact sensing to that. I think one of the things that people are going to find, particularly as ablations start to move into an ASC environment, ambulatory surgical center environment, is that being able to provide safe procedures, predictable procedures, but also cost-effective procedures is going to become really important. The ability to do a FARAWave procedure, map it on Opal without having to pull out any additional hardware, any specialized mapping Catheter, makes it an incredibly attractive economic offering to physicians and hospitals. We have five minutes. There's so much that we could get to. I want to ask on PFA competition. Your peers reported this morning, this discussion's competing with their call, classic. I don't make the calendar. How do you see their best product coexisting with your portfolio in the market? I mean, is it the lines are well drawn and defined, and this is a major rising tide, and there is room for more than just one player to participate, or do you find that it is incremental tension for FARAPulse's ability to continue gaining share? Yeah. I think, first off, rising tide does lift all boats. The AF epidemic is so huge, and ablation today is so underpenetrated that market growth itself is a really important driver for us and in some ways maybe more important than share. I'd also say their use case right now is very different than FARAWave. It's still a point-by-point ablation paradigm, which is, frankly, it's a tedious, more expensive procedure. Where they're seeing a niche today is in the redo cases. We think we've got a very compelling competitive offering when it comes to redos. If I got to win somewhere, I'd much rather win in the much bigger market, which is de novo ablations. Okay. Lauren reminded me that you're the Chief Medical Officer for all Boston Scientific. So we're going to get out of the EP lab. I am going to stay on cardiology one. Renal denervation, potentially a big growth area for the industry. You won't be the first mover, but you might be a fast follower. Ultrasound could be a better mousetrap. What gives you confidence the safety box will be checked for your device? No cooling system, just using natural blood flow. I'm interested in what can I go dig up on the interwebs that is going to make me feel good that this will work on the safety side of things? Yeah. The ultrasound Catheter, the company that we bought, is unique. I think, first of all, as you said, I think it is a better mousetrap. There's a lot of reason to think that ultrasound is a better technology for doing denervation as opposed to sort of getting back to the bad old days of RF. We've got a huge amount of experience in other vessels that says that high blood flow can cool sufficiently to avoid endothelial damage. The thing that is unique about the TIVUS approach, that's the company that we bought, is it has these fins that stabilize the Catheter within the vessel so that you can deliver the ultrasound energy without occluding blood flow. The ultrasound Catheters on the market have to use a balloon to stabilize itself in the artery to deliver the ultrasound. As a result, it occludes flow. Heating is a real issue. Flow in the vessel is so fast. Again, you're bringing blood that's heated at 98.6 degrees. That's constantly cooling. I just say we've got a very large experience with other energy sources like RF that heat and in other areas, including intracardiac ablation, that say that that kind of cooling is absolutely sufficient. Two minutes. Final word to you, Dr. Stein. Three things elsewhere in the portfolio. Street sleeps on. I'm going to get. You're excited. Okay. Four. You're really excited about. Four. Agent drug-coated balloon. That's also a phenomenal product for us. It's a phenomenally successful launch. Shouldn't get lost in all the appropriate excitement about FARAPulse Watchman. Looking forward, Bolt getting into intravascular lithotripsy for calcified coronary lesions, having a fantastic competitor, Shockwave. I think outside of cardiology, the two things, and it's like naming your favorite children. I'm going to stop with two other things because I'm looking at the clock. Our endoluminal bariatric surgery within our endoscopy division, I think having the only devices right now that are FDA cleared for doing endoscopic bariatrics is extraordinarily important. I think the GLP-1s are our best friend in really bringing to the forefront the importance of treating Obesity and the downstream effects that has on health overall. I'd also say our interventional oncology and embolization division and the opportunities that we've got, particularly with our Y90 beads for treating a variety of solid tumors, I think really exciting in terms of where we're going to be, not just over the next year or two, but really over our long-range plan and beyond. That was excellent. We packed in a lot. Five seconds to spare. Dr. Stein, Lauren, thank you for being here. Thanks so much. Thanks.