Maybe if I could, let me start with 2024. We had a tremendous quarter here in Q3, and we're on track for a tremendous year in 2024. So just to recap, we grew our organic revenue 18.2% here in the third quarter, delivered adjusted operating margin of 27.2%, and grew our EPS 27% in the quarter. Bottom line , EPS 20%. So, we feel we're delivering on our objective to be the highest-performing large-cap medtech company. The performance there has been very broad-based. So we see across each of our business very strong performance that's driven by our category leadership strategy, our differentiated portfolio. Then we have two very strong growth catalysts in WATCHMAN and EP, and particularly FARAPULSE, which is just transforming the AFib ablation market, which I know Nick here is eager to talk about a bit.
So long way of saying, love the momentum, love the broad-based growth that we have, the two strong growth catalysts. And we see that carrying into 2025. But you're right, not gonna give guidance for 2025 yet. We'll do that when we get to end of January, early February.
Okay. I'll just keep asking until you find your.
All good.
Okay. Well, thank you, Nick, for joining us. Maybe let's talk about FARAPULSE, since you know, we only have about 30 minutes on the.
Yeah.
Stage here. So just wanna make sure we touch on that, since we do have Nick here. And just maybe talk about. I'd be curious to hear so you guys talked about the fact that you are tracking ahead of that 40%-60% of ablations are PFA at this point, by 2026. You're tracking ahead of that. How has the AF ablation market evolved since, you know, your Analyst Day in September of 2023? And how has your thinking about the market changed? And particularly appreciate that PFA's taking a bigger share of the market, but really thinking about that denominator of how many AF ablations are now being done.
Yeah. Well, first of all, thank you for the invite, and it's great to be here. We are seeing some accelerated adoption of electrophysiology specific with FARAPULSE. And I think a lot of that hinges upon our ability to supply customers. We've made some significant investments many quarters beyond what we thought our launch date was gonna be, even with a nine-month pre-approval. So generators, catheters being readily available for those customers who are ready to commit. And the commitment came rather fast. And so we were really excited to see that from a lot of these major centers around the world in where we received approval. We also have seen the user experience to be adopted rather quickly. People see that it's a very easy tool to use. They appreciate the safety and the efficacy associated with it.
And so once one starts to use it, it becomes very simple to rebook another patient. And so we've seen that accelerate rather quickly. And we see that happening a little bit on the higher range of what we said at Investor Day a few quarters ago. So we're really excited to see that play out. We see that continuing to happen as we go to new markets.
Okay. Got it. I think the other big question on folks' minds is obviously we've gotten two more PFA approvals in.
Yeah.
Within the last month, you know, how this has been such a big growth driver for Boston Scientific over the last year, how to think about the competitive dynamics as we head into 2025. And I'd love to hear a little bit more about how you guys have built a competitive moat. How wide, how deep is that competitive moat, and how we should think about that?
Yeah. It's a great question because we've got this mentality that you never arrive. We're already thinking about the next-generation device as new strategics enter the market with pulsed field ablation. And the good news is that other key strategics that have done a great job of leading the market in the past have realized that PFA is here, and it's here to stay. And so that only helps push traditional RF and cryo users to pulsed field ablation. And as the leaders in that, that really positions us to continue to innovate. Our user experience scores really well with a variety of different operators today. We see that continuing to happen as we now have introduced the integration aspect of the FARAWAVE catheter.
For those that prefer to have some sort of integrated mapping option and less exchanges and not have to pull out another $3,000 mapping catheter, we see people taking advantage of the economics. So that is now available in the U.S. market, will be available in other markets here in the very near future. And then we see us bringing out yet another iteration of FARAWAVE here in the next couple of quarters, as well as FARAPOINT in 2025. So we're gonna continue to innovate and deliver new products and more options to customers and try to really offset any sort of strategic, competitive threat that we see.
Is the first-mover advantage here a real thing if we think about it?
Absolutely.
Yeah.
I see, you know, we've got some of the largest, AF ablation centers in the U.S. and in Europe now that have done well over 1,000 cases. So they've treated well over 1,000 patients. They've got their own personal experience. And they're seeing that as something that is the standard that has to be beat.
Yeah. Okay. I just getting back to, you know, the number of AF ablations being done, and one of the things that strikes me about FARAPULSE is when I talk to doctors, you know, it's democratizing, give Jon credit for.
There you go.
Doctor.
Yeah.
Democratizing AF ablation for all electrophysiologists. Can you talk about that a little bit and the ease of use of the device? And my perspective is, or my sense is that you guys are still just in the very high-volume EP centers. So when this gets into, you know, your bread-and-butter EP, like, how we could see growth here take off?
Yeah. I think there's growth in many ways as you think about 2025 and 2026. First of all, we've got an indication for PVI. But as that expands, as we showcase the ADVANTAGE results in the first half of 2025, we believe now you can get into a persistent patient population.
Yeah.
The versatility of the FARAWAVE pentaspline design is for real. People aren't waiting for the clinical data to surface. They're already doing posterior wall work. They're already doing other ablation lines. And it's just super easy to use and super safe. And it happens to be effective and very, very efficient. Most hospitals who were treating, say, 10 patients on average a week are now treating 13, or 500 per year are treating 650. You see almost a 30%+ on average increase.
Yeah.
In terms of being able to treat more patients with the pentaspline design.
Okay. And the other question is just back to the competitive dynamic. You know, are all PFA devices created equal?
Yeah.
I would love to hear your thoughts on that.
Yeah. They're certainly not. I think, technically and from an engineering standpoint, even our own catheters that have different form factors, they're all different because the waveform and where the electrodes live and how that energy's delivered to the cells are slightly different. And you're gonna get different results if it's not developed in a way that can achieve the efficacy that the engineers have designed the product to be. And the energy can't be underpowered, and it can't be overpowered. And so they've really figured out over the course of the last decade, you know, with the help of legacy FARAPULSE, what is that efficacy range in the waveform, where do these electrodes sit in these different catheter forms, tips that we have, and how that really plays into efficacy and call it efficiency and ease of use.
And that's why we really believe in voice of customer, you know, understanding what they want and how you can deliver a really good, efficacious, efficient lesion.
Okay. And if we think about the competitive environment that's going to heat up here in the U.S., I mean, you've had competitors in Europe for.
Yeah.
A year-ish.
Yeah.
Should we think about like, is that a good proxy for what we could see here in the U.S.? And are you guys still growing above market in Europe?
Yeah. So I mean, you're right. Most of the strategics have had products that are in the European market for either a year or well over a year.
Yeah.
Quite frankly, every market's different. So you can't say that our market here in the U.S. and in Asia-Pacific, where we're now launching in both China and Japan, will be the same. They're all a little bit different. But if it's any indication, I mean, we've got the vast majority of share in the European market. We've done really well there. We just think, to your point earlier, the user experience and the time, the first-mover advantage in big markets like the U.S. and what'll now be in other markets throughout the world, we think that will allow us to have the majority share.
Okay. Can you talk a little bit about how, your resurgence in the EP business has maybe helped other businesses that call on the EP? I mean, Boston Scientific has a very big CRM business.
Yeah.
You're calling on the EP for other products. Like, what have you seen in your other businesses because of the success of FARAPULSE?
It is a very big advantage. We were very deliberate a number of years ago to have an AF portfolio when you look at WATCHMAN, Baylis, and our legacy cardiac rhythm management devices with now a loop recorder in LUX. All of those products are surrounded by same patient, generally the AF patient or people who have arrhythmias, as well as the same operators, electrophysiologists, same CVSL, administrators at hospitals. So it's very convenient that we have those trusting relationships that allow us to take advantage of the opportunity of a process that we already know and how people work and what it takes to really understand how do you drive the adoption of these new technologies in an appropriate way that's economical and in some ways can be very advantageous if you wanna bundle these products for that same operator.
Okay, and you guys are launching mapping system, FARAWAVE.
Yeah.
Just curious about how to think about that because right now you don't have a mapping system. You've had this success with FARAPULSE without mapping. You have, you know, other mapping systems on the market that have adapted to.
Yeah.
FARAPULSE. How should we think about FARAWAVE and the mapping system and adoption there in the U.S.?
Yeah. Great question. We have had a mapping system. It was connected to our RF portfolio. What we didn't have was the integration of the FARAWAVE catheters with, call it, this mapping system now. And together, what this does is for those that like mapping, historically, you can impedance track via our, call it, traditional mapping catheter, the ORION, or even competitive mapping catheters if one felt comfortable doing that. It's an expensive way of doing things. So we felt it was important to put a sensor in the FARAWAVE catheter that people like, again, that scores well in the user experience, to take that catheter and be able to magnetically track it for more precision, less exchanges, and to drive that continued efficiency and not impact whatever workflow you feel comfortable using that catheter today.
So today, we think it brings yet another option for those that like mapping to have true integration. And we just launched it a few weeks ago. It's scoring really well. And we think that just gives another option for those that desire to have integration.
Okay. Got it. Can we talk a little bit about the OPTION trial that's coming up here.
Sure.
Saturday?
Yes.
We'll see the data and how we should think about that, not just for WATCHMAN, but also, you know, it's post-ablation patients, so relevant for EP.
Yep.
You know, I know we have to wait for the data.
Yeah.
We'll see what the data says.
Sure.
But assuming it's positive, what could that mean for WATCHMAN?
Sure. Well, Nick, maybe I'll take the first part.
Yeah.
You can add any comments on EP. So maybe just a quick reminder. OPTION is our clinical trial comparing WATCHMAN head-to-head versus oral anticoagulants in post-AFib ablation patients for stroke prevention and non-procedural bleeding. And I'll read out this Saturday at AHA, as you said. If that reads out positively, we see that as adding another one to two million patients into the indicated patient population over time. That's on top of the four million patients that are currently indicated today for WATCHMAN. So as it relates to the LAAC market, we see that as supporting the strong underlying growth that we see there. And together with CHAMPION, we see those two trials helping to drive that market from roughly $1.7 billion today to $6 billion in 2030. So I'd say we see more of an impact to the WATCHMAN franchise than the EP franchise.
But certainly, having the two together, I think that puts Boston Scientific in a very unique advantage position.
Yeah. I think Jon did a great job of highlighting the design and the intent there. You know, Dr. Oussama Wazni at the Cleveland Clinic is the principal investigator that will be presenting this data set here very shortly. And we're excited to see what that brings. We think it can help another population of patients. We've had a really good track record of helping these patients who are struggling on their blood thinners for a variety of reasons. And this is the largest ablation trial that's ever been executed, you know, given 1,600+ patients. So we're excited to see what the results show. And we think that, you know, our intent is not only to focus on innovation, but how do you focus on the clinical evidence?
These are big trials because if they go really well, they can be incredibly rewarding. If they don't, you know, they can challenge us a little bit.
Mm-hmm.
We're excited to see what that brings in in a few days here. I think it's an opportunity to potentially help a lot more patients.
Yeah. And I know, Jon gets frustrated with me because he has to rein me in on my WATCHMAN estimates a little bit here.
I would never rein you in.
But, well, yeah, no. But he's like, "Well, here are all the reasons that maybe you're getting a little too excited." So maybe talk about, you know, the steps from let's assume the trial's successful. Like, why wouldn't this be an inflection point in 2025 for U.S. WATCHMAN sales?
Sure. But well, to be clear, we're looking forward to that data reading out. I'd say the biggest barrier to adoption today for WATCHMAN is that indication, and so today, oral anticoagulants are frontline therapy, so to receive a WATCHMAN, patient needs to be contraindicated to OACs, or in the U.S., have medical rationale for receiving OACs. So with OPTION and CHAMPION, we're looking to establish WATCHMAN as a frontline alternative so that patients, physicians can choose WATCHMAN or OACs, so after OPTION reads out, we would then expect to, you know, submit for the indication expansion. We expect to receive that second half of 2025. Up next then would be the readout of our CHAMPION trial, and that's the bigger unlock for us. That's our all-comers trial, WATCHMAN head-to-head versus OACs. We expect that to read out in the first half of 2026.
And with the two together, assuming they read out positively, we see that as increasing that indicated patient pool from the four million I just mentioned to 18 million in 2030. But we need the trials to read out positively, get the indication expansions, you know, and ultimately, we'd use those to get guideline changes for WATCHMAN so it is a frontline therapy.
Okay.
So we expect that to play out over time, but expect that to sustain, again, that very strong market growth that we're seeing.
Yeah, and from a competitive perspective, I mean, you have one competitor on the market, today, and you guys still have 90%+ market share.
Yep.
You will have, presumably, assuming they have positive data. I don't know really timing for this, but within the next few years, another competitor. I mean, again, back to that competitive moat. I mean, you guys have executed so well with, you know, the first competitor.
Sure.
How do we think about that competitive moat for WATCHMAN?
Yeah. So we've maintained a very high share position and are doing very well there. And Nick mentioned it earlier. The key is, we haven't sat still on innovation.
Okay.
The tail end of last year, we launched our WATCHMAN FLX Pro device. That's our third-generation WATCHMAN technology. We're already working on our fourth-generation device. The technology is easy to use. It's safe. It's highly effective. We are also innovating and launching differentiated technology in the accessories to the procedure.
Mm-hmm.
So we launched our two-tier access system at the start of the year this year. We have our VersaCross transseptal crossing technology. So very high focus on innovation. So that's key for maintaining our leadership position. We've talked about the clinical evidence with OPTION and CHAMPION. We've got a number of other trials. So we're generating a lot of clinical evidence to advance the field, and to deepen our understanding of the benefits of WATCHMAN. And then we have a tremendous commercial team and physician and clinical support team. So for all those reasons, feel very confident that we'll maintain our leadership in left atrial appendage closure.
And Europe has been. It's interesting 'cause this is a market that has taken off in the U.S., but Europe is still pretty small. I think OUS sales are like 10% of WATCHMAN sales. And I think part of it is because we haven't seen that definitive clinical evidence of non-inferiority versus NOACs. So how do we? I appreciate CHAMPION is the big unlock, but I mean, OPTION's gonna be the first look at this, right?
Yep.
Is that something that we could see really drive the European market?
I think that CHAMPION trial will be.
It's the CHAMPION trial.
Will be the key.
Yeah.
To really getting the guidelines changed outside of the U.S., and helping to drive that market and that patient population.
Okay. And then last question on WATCHMAN. I'll go back to EP. Sorry.
Sure.
Nick, but you know, this is gonna be the first look, and appreciate these are different patient populations. We're looking OPTION versus CHAMPION, but is there any sort of, you know, read-through to potential success of CHAMPION if OPTION successful? I mean, how do we think about that?
They're separate trials. So we need to follow each to the end and read them out. But I think that's reasonable to assume. If we see a positive outcome here this Saturday in OPTION, it would increase our confidence in the CHAMPION trial.
Okay. Got it. All right. And then back to the EP.
We can talk about WATCHMAN.
Yeah.
I spent 10 years of my life with it. I love that product as well, so.
It has been pretty phenomenal, but no, while I have you here, I'm gonna go back to the EP business. Just thinking about so you have, you're launching in China and Japan in 2025. Can you maybe frame the market opportunity there for us and how to think about that for the OUS piece of the business?
Yeah. Both of those markets combined are a multi-billion-dollar opportunity, well over a billion, both Japan and China. We've never really had a stronghold in China with our EP ablation business. We do a great job with our WATCHMAN business. So again, that presents a really good opportunity to bridge that new introduction. We just launched there a few weeks ago, and it's going really, really well. We just see as we enter those new markets, they're large markets, a tremendous number of AF patients, not only today but continuing to grow over the course of the next 5+ years. We see us, you know, taking a leadership position in both of those markets and trying to do really, really well in treating those patients and contributing to this growth story over the next several years.
How quickly could those markets ramp? Like, is it U.S.
Yeah.
You guys have ramped phenomenally. So just thinking about, like, how to think of.
Yeah. I think time will tell you exactly the answer to that. But I can tell you we've got a great supply chain and manufacturing team that gave us a competitive advantage to be able to build enough generators and catheters for both of those markets. We've also hired a number of mappers and people in those geographies who know electrophysiology to help us have a really good representation in those markets. So I would anticipate some relatively rapid growth there as well. You know, I think the tool, the versatility of the tool beyond just pulmonary vein where the indication is today in the U.S. has been aggressively pursued even beyond that. People aren't waiting for the data.
Mm-hmm.
And they're doing posterior wall work. I think in markets like Japan, you'll see more compliance until we expand those indications. In China, it remains to be unknown whether they're gonna use the tool in a very versatile way before the data hits their markets.
Okay, and maybe let's talk about indication expansion. So first, we'll have ADVANTAGE in second half of.
We'll have the ADVANTAGE data publicly available the first half of 2025.
First half.
It'll be publicly published sometime in the back half of the year, where we think we can get that indication.
Indication. How do we think about that expanding?
Yeah. I mean, it's very opportunistic. I think one thing we can all agree upon is that we need better solutions for persistent patients.
Yeah.
We see people already motivated to go treat them today before the data's even out there. We'll see that data here in the first part of 2025. We're very optimistic about how we can treat that patient population as well.
And then I have to ask about AVANT GUARD.
Yes. Yes.
I know you guys can't say.
You should.
You can't say a lot, but.
Yeah.
You know, I've talked to Jon about this multiple times, and there's the totality of evidence out there. I think the big question for AVANT GUARD is, is there some smoking? It's less about.
Yeah.
That indication. It's more about, is there some smoking gun we don't know about?
Yeah.
FARAPULSE yet?
You should ask the question. I can appreciate, you know, the unknown is very uncomfortable, and I think what you need to take away is we're very excited about this trial. We wanna complete it. In order to do that and do what we ultimately wanted to do, we have to be very, call it confidential about the data until it gets published. So that's all I can tell you at this point, I think the good news is, and Ken, Dr. Stein, did a good job at the earnings call really highlighting our intention to restart this trial, and here we are today. We restarted it, and I would just tell you that in the coming quarters, as we get that completed and published, I think it'll make sense to everybody what.
What happened there?
Our observations were.
Yeah. And if we can look at the totality of evidence that's out there today and.
I mean, we.
That's pretty indicative of, like, the safety and efficacy of this device.
That's exactly right, Danielle. We've got the largest experience.
Yeah.
Well over 125,000 patients. You know, we'd hope to double that, if not more, next year this time. We just feel very optimistic about the body of evidence.
Yeah.
People's personal experience, some of the largest centers of the world, and how beneficial this has been. To patients, to them as operators, and to the administration being able to treat more patients.
And so just on that point, capacity has been a big issue. This is the AF ablation market has been growing.
Yeah.
Double digits for over a decade. But we're still only talking about 350,000.
That's right.
Patients treated last year, out of 2 million paroxysmal and another 2 million persistent.
Yeah.
Patients. So how are you seeing capacity? These centers deal with the capacity issues.
Hospitals do a good job of figuring that out over the course of time, whether it's adding more electrophysiologists to treat these patients, adding more cath labs, adding more capacity in the preoperative and postoperative setting, not just the intraoperative setting, so I think hospitals are doing their part to make sure they can capitalize on this 'cause they wanna treat more patients, and it's economically viable for them to do that.
Yeah.
And I also think, you know, what people ask me a lot about is, you know, ambulatory surgery centers. What does this mean in the future? We envision that happening in the future. And so when we design and develop these products, the products have to be able to meet the demands of different environments. We think we meet the environment really well in the hospital setting by giving these options. We believe in an ambulatory surgery center, it'll likely be non-mapping for a lot of these.
Yeah.
Paroxysmal patients, so we are very favorably positioned, if that's where things go over the course of time, to be able to give that option to those patients and operators to be able to meet those capacity constraints and trying to expand and help treat more patients with what's out there.
Okay. I'd be curious. So we touched on earlier that 40%-60% of ablations being done, PFA you're tracking. Ahead of that, you said that by 2026. What has surprised you, Nick, the most.
Yeah.
In this launch that, I mean, it's exceeded even the most bullish expectations, and it's exceeded your own. So why?
Yeah. So I think there's a lot we can talk about here. In my 30+ years in med tech, if you develop the tool to be able to meet the various demands of these operators 'cause it's when you look at just the heterogeneity of how people in electrophysiology do things, like, there's no one way.
Yeah.
And so we're very deliberate about being able to provide a product that is very versatile. So for me, the biggest surprise was the RF users, those loyalists. Like, that was 80% of the market.
Yeah.
How interested and how fast they moved. So that was probably point number one. And point number two, the versatility tool to be able to use it well beyond pulmonary veins.
Yeah.
And that's why we're doing trials like ADVANTAGE, call it AVANT GUARD. And we'll start a new trial, ReMATCH, here next year. So we're gonna continue to expand indications and the versatility of what other lesion sets we can provide to patients and these operators like the versatility of that tool. But we're also gonna innovate and offer new tools. We'll have FARAPOINT in 2025, the point PFA catheters. We're working on FARAFLEX. That's our large area-wide or I should say our wide area focal catheter that I think is gonna be another addition. And these are all different tool sets that are gonna provide options for different reasons to different operators. We're gonna compete with ourselves here. We admire what the strategics have done over the course of time. We are the leader in pulsed field ablation. We're gonna continue to innovate amongst ourselves.
If we've got a great product, we're not gonna settle there. We're gonna continue to innovate and offer more, and we think that with that approach, it's worked for us on the WATCHMAN side of the business. It's working for us on the Baylis side of the business, and it's also gonna work for us in the pulsed field ablation side of the business with FARAPULSE in being able to just continue to innovate, make things better for patients, simpler for operators, and more efficient for administrators.
Okay. And just on the WATCHMAN plus EP side of things, I mean, 65% of WATCHMAN procedures are done by the EP. So same call point. I appreciate that's in the structural heart side of the business. But how do you leverage those two products to sort of.
Yeah.
Cement Boston Scientific's leadership position?
Jon can also pipe in here. When you look at the cardiology portfolio, we've got a really good presence with interventional cardiologists because of all the other things we've offered over the course of time.
Right.
Really good presence and sense. And also, you know, our cardiac rhythm management business. So when you look at both sides of those equations, we've got a cardiology team that represents the broader business. And everything from representation technically, economically, contractually, as you look at all that, we can be a one-stop shop for those that wanna take advantage of that efficiency, whether it's a health system, whether it's a hospital. Those key relationships we think could be very advantageous to us, Danielle. And it's because of the trust and the pioneering spirit that we've had with all these different therapies across the board. And we think we're gonna continue to leverage that with both interventional cardiologists and electrophysiologists with all the products that we offer in the cardiology portfolio.
Yeah. Do you see that, 65% being done by EPs? Do you see that shifting over time to more interventional cardiologists, or do you think it's.
Well, it.
Especially with OPTION, I feel like it's gonna be.
It remains to be unknown. There's still a lot of electrophysiologists. If Dr. Sutton was on the stage, he would tell you, as an electrophysiologist, there's a lot of electrophysiologists that still don't do WATCHMAN.
Okay.
If OPTION is positive, you'll probably see.
More.
More EPs.
Yeah.
Doing this. And it depends on the market. Certain markets, the European market is primarily interventional cardiologists treating these patients with WATCHMAN. So it depends, right? And so each market's a little different. You can make the argument in China it's a little different than it is in Europe as well. But at the end of the day, we wanna be able to treat that cardiology patient.
Yeah.
With these different specialties and everything we offer.
Okay. And, sticking with interventional cardiology, I have to.
Yeah.
I have to ask about ACURATE as well.
Yeah.
Not to promote myself, but we hosted a very good call yesterday with an E.U. KOL. And he, you know, and this was consistent with feedback we've gotten thus far. No change to practice in Europe, where you guys have a decent share position.
Yep. Yep.
So maybe talk about how you're looking at the risk to European sales because of the ACURATE IDE and then anything you can tell us about, you know, the regulatory pathway from here. It sounds like you guys are very committed to commercializing this, so.
Yep. And maybe just quickly, we've kinda called 60% EPs, 40% ICs for the split.
Oh, for WATCHMAN?
You got it.
Nick, you told me 65%.
Yeah. Who's counting it right? So, but on ACURATE, so we like the business that we have in Europe. It's about a $200 million business today. We receive very strong physician feedback. We're just now launching our ACURATE Prime valve, our next-generation valve in Europe. It has frame enhancements, larger size. That's a portion of the market that we'll be able to participate in now, and so I think you're right, Danielle. The physicians in Europe are looking at their real-world experience where they see the benefits of ACURATE, the positive patient outcomes, the totality of the evidence, and they're drawing on the learnings from the ACURATE IDE in the U.S., those procedural optimization steps, and ensuring those are embedded in their procedure and their workflow to the extent they aren't already.
And so we don't expect a significant impact to our business in Europe. And as it relates to the U.S., we're collaborating with the FDA now on that regulatory path forward. And as we have updates there, we'll be sure to let you know.
All right, well, with that, we are about at time, so, gentlemen, thank you so much for your.
Danielle, thanks for the opportunity.
Yeah.
Thank you. Thank you. Yeah, yeah.
Thank you.