And your first question comes from Robbie Marcus with JPMorgan.

Congrats on a great quarter. Bernard, 2 for me. I'll just ask them both upfront, both revenue-driven, TAVR and TMTT focus. First on TAVR, clearly, a very strong quarter. It appears you're getting the benefits of market expansion from asymptomatic and some competitive wins from your main competitor. The share seems to be shifting over. I'd love if you could dive into those 2 and talk to the trends you're seeing on competitive share shift, market expansion? And if you want to throw in how different U.S. and outside U.S. growth was considering the focus there. And then on TMTT, my guess is it's all the products, PASCAL and EVOQUE that's driving the upside. But if there is any one that contributed more aggressively to the 7% sales beat versus consensus. I appreciate any color.

Thanks, Robbie, and great to be with all of you. So allow me to start with a very brief comment about the company performance. We are very excited about it, very pleased, better than expected. And this is reflecting in our strategy. Our strategy in structural heart is working very well. I want also to recognize our team who is having a flawless execution globally. We have seen in Q2 and even in Q1 of this year, great performance by therapy and in each of our regions. So again, all of this give us confidence. So back to your question about TAVR. I would say on TAVR, a little bit of the same, better than expected. And these results are not happening by chance. They are the result of years of technology advancements, about 20 years, building world-class evidence. All of this together has positioned SAPIEN as the benchmark TAVR platform globally with regards to valve performance and valve durability. So it is why it is important for us to always step back and look at why the results. And we believe that because of this, our results are durable. Now if you want to compare U.S., OUS, our growth rate in TAVR were very similar between U.S. and OUS. And the way the result of this renewed focus on TAVR given all of the clinical data we have produced in the last 12 months and many years. So that's probably what I want to say about TAVR. I'm sure Dan later will be able to provide more details. On TMTT, yes, I think the value of the portfolio is now clearly in action. We have seen PASCAL doing very well with an increased adoption also in U.S. and in Europe because of its differentiated feature. EVOQUE also have seen an acceleration and is doing very well. And M3 is also having some -- even though it is early, it is going very well. We got very good feedback from European physicians and U.S. physicians. So the beauty of this quarter is it is altogether. And again, here, I'm sure Daveen, later today, will provide more detail about TMTT. So thanks very much for the question, Robbie.

And your next question comes from Larry Biegelsen with Wells Fargo.

I'll echo my congratulations on the really strong quarter here. Bernard, just one on PROGRESS and one high-level question for me. So Bernard, on PROGRESS, can you talk about why you highlighted the heterogeneity of the PROGRESS population in the press release and in your prepared remarks? And if PROGRESS is positive, how would you frame the impact to your TAVR business relative to earlier new indications like asymptomatic?

Thank you, Larry. And let me start about first why we decided this time to split the PROGRESS presentation in 2, the baseline characteristic at New York Valves and the full presentation of the results at TCT. We did that because a little bit of a learning from EARLY TAVR. When you study a disease in 8 minutes of a presentation, it is very difficult for a physician to provide everything, what the study design is, why we did it, the baseline characteristic and then the results. And so here, given the importance and given the learning from EARLY TAVR, we said it was probably important to split it in 2. So we went a little bit deeper into, hey, one is potentially the size and what we have presented at New York Valves is that moderate is at least as big as severe. Some analysis is showing even bigger. This population is very diverse, very complex. And so we thought it was important in advance. So people understood this disease. We also talk about the fact that there is no difference in age between the severe and moderate AS. So that's a little bit about what we wanted to achieve here. Maybe, Dan, you want to add a couple of things on that?

Yes. I think you covered it largely. I mean, it's the first randomized trial looking at the treatment of moderate AS patients. And the heterogeneous nature of this population is not well understood. And I think understanding the baseline characteristics a little bit better give us a greater insight into that and just help us understand when we get to digest the results at TCT later this year, just help us focus on what those results really mean. And so as you well know, Larry, this is a trial studying moderate AS patients with at least one at-risk feature. And I think it was important to describe what they are. And that population is at least in the literature anyway, suggests that it's representative of about 50% of the total moderate population. So it's still a large population here. And so this is -- we shouldn't be surprised by it, but maybe some people were -- maybe some people don't understand that the severe AS patient population and the moderate AS population are very similar in terms of their age. In fact, there's -- again, the literature on prevalence suggests that there's only 1-year gap between severe and moderate. And so all those sort of details come out in the baseline characteristics. And then again, it allows us to sort of answer those questions and then focus on the results when they drop at TCT.

Yes. And with regards to impact, Larry, think about -- you know that the practice of medicine is moving slowly. So we expect minimal impact in 2026. And our long-term guidance for TAVR, mid- to high single digit is here to accommodate all of these kind of scenarios. What we will do at investor conference is provide a more detailed guidance, obviously, for 2027.

Thanks for that comprehensive answer. But I wanted to ask about your comments about 10% total company growth on average because you didn't highlight that on the Q1 call and the implied second half underlying growth is about 9%, which is slightly below 10%. So I know it's really early, but is there -- do you believe you can grow 10% underlying next year? And if so, what are the drivers?

Just to be clear, Larry, my comments on 10% is about the company. And it is a guidance comment long term about the company with TAVR growing between mid- to high single digit. I think this was our comment that we did at the investor conference, and it was the same comment that we did at the end of the Q1 and the same I did today.

No, I got it. I meant the total company, Bernard. Sorry if there's any confusion. I was asking about total company, not TAVR, but I'll leave it there.

And your next question comes from Travis Steed with Bank of America.

Congrats on a good quarter. Just maybe as a follow-up somewhat to Larry's question. Given the tough comps in the second half, you mentioned you still expect normalized seasonality in Q3 this year. Just want to make sure I understand what normal Q3 seasonality means. Looking back at the model and worldwide TAVR kind of down between $15 million to $30 million sequentially from Q2 to Q3, which to me, my math puts at a kind of 5% to 6% worldwide TAVR growth. Curious if that's kind of the math that we should be doing or if you'd say anything on the seasonality?

So maybe let me try to put in perspective how we think about the guidance for 2026. First, we had a better-than-expected first half, Q1 and Q2. So we took this sustained performance into consideration in raising our full year guidance. In addition, what we talked about in Q1 and today is the fact that we expect the second half growth rate to be artificially low because of the high comps from last year. I don't know if you remember, but last year, the summer was very high from a growth rate. So we have a very high comp 2H of 2026. And we took all of that in consideration to give you the guidance, 10% to 11% for the total company. So is it good enough here? Or do you want more detail on this guidance and 1H and 2H dynamic?

Yes. Just there was a comment in the prepared remarks about normalized seasonality in Q3. I just want to make sure we had that down.

Yes. So this year, we don't expect like last year to have a very strong summer basically. And what you are going to see is basically Q2 to Q3, you are going to have some incremental dollars, Q2 to Q3.

Okay. And then the kind of the second question is more on the NCD. I don't know how big of a deal you think NCD is on kind of TAVR growth next year or how to quantify how many centers this opens up? Or does it open up capacity for TMTT as well as TAVR, just any more on the NCD now that it's kind of more finalized?

Maybe I'm going to ask Dan to comment on the NCD itself, and then we can discuss about TMTT.

Yes. Thanks for the question, and it's an important one. First of all, we're really pleased, right, that CMS is running this process. And the good news is we're getting nearer to the end of it. We've just seen a draft policy position and the second comment period, the second public comment period is now closed. And so final policy memo is expected in September. And so this is where we are in the process. When you look at that draft, there are a couple of opportunities there. We're encouraged by it, number one. I think that's really important to say. And I look at it in 3 different ways, right? The big reasons to sort of like open this up and revisit it. first one is we're encouraged at least in the draft, it says that there's a pathway for asymptomatic indications to be covered. That's really important. That's one opportunity. The second is that the -- that there's a recognition that after all these years that symptomatic severe aortic stenosis is a reasonable and necessary procedure for Medicare beneficiaries and that it can be covered without evidence development. And that's super important. And then the third is modernization of the policy around empowering heart teams to give timely access to care for patients in need. And so these are the big ones that present what we would say tailwind or potential catalysts as far as future opportunity in 2027 and beyond. Your comment specifically about new centers, if you think about it, the current draft policy states that cardiac surgery programs still need to be in play and exist for a TAVR program to be covered or TAVR procedure to be covered. And so if you think about that, where we are about 850-odd plus centers and how many surgical centers, there is room for some expansion, but that's not the big add. The big add will be how efficiently patients can be processed referred, diagnosed, referred and treated and what that means from a program efficiency perspective, and that will be very, very important as demand we anticipate to continue to increase based on indications and evidence.

Do you have a follow-up question?

No, that was it for me.

And your next question comes from Joanne Wuensch with Citibank.

Thank you so much for taking my question and for delivering the quarter. So we're getting a lot more questions on PROGRESS. And I was curious if you could sort of level set, assuming that the clinical data looks good, how you think the adoption rate might be? And how do you think the steps would be towards having that contribute to revenue?

Yes. I'm going to let Dan take this one.

First, we can make a whole bunch of assumptions. I think like the first thing is we have to see the results, and those results will be, as you know, presented, published at TCT this year. But if I -- taking a step back, I think we need to think about this patient population in a very similar way as the asymptomatic patient population. These are new indications that don't have a predicate, right? We spent 15 years doing a lot of evidence generation on TAVR as an alternative to surgery. And whether it be an asymptomatic patient population or a moderate disease patient population, the guidelines are not -- surveillance is the recommendation for these particular indications, not surgical intervention. And so there's an element of change management and human behavior change and education, et cetera, that has to go along with any of these new indications or new data sets. And so I think that we can look at that very similarly. I think it's going to be important data. There's going to be a lot of learning. But we can think about those 2 things in a similar way relative to, say, high risk, intermediate risk, low risk where it's just against an existing predicate. Does that make sense, Joanne?

It does.

And your next question comes from Pito Chickering with Deutsche Bank.

Great quarter. I'll put my 2 questions upfront. Looking at PASCAL tricuspid with the approval expected in the fourth quarter, and we're seeing the data at TCT in the fall. Is it safe to say that the trial is successful and has already been submitted to the FDA? Any color there? And then the follow-up is with market share gains you've seen in mitral with PASCAL, can you talk about how you think you're positioned to enter the tricuspid market with PASCAL?

So I can tell you, we are very pleased about the PASCAL performance. But I'm going to let Daveen provide more detail. He's very close to it.

Yes. Thanks, Bernard. Thanks for the question, Pito. Yes, as you said, exactly right now, we're expecting both the data to be released at TCT this year. I think we'll all look at the data together, and our expectation is for a Q4 approval in the U.S. is our current planning right now. If you look at PASCAL tricuspid, however, so far, we've obviously had this technology now in Europe for a few years. And we see that some of those differentiated features with the PASCAL device on the mitral side come off even more so in the tricuspid side. So physicians can see that some of those cool features about independent grasping, et cetera, they really make a difference in treating their tricuspid patient. And as a result, we see that physicians want to use PASCAL more and more often in the tricuspid situation in Europe. So I think it's on the back of that as we think about the U.S. tricuspid approval and launch as that next layer of growth, as that next wave of potential growth for the TMTT business where we think that those differentiated features should be able to come over to the U.S. We've got a large number of physicians who were in the trial, were in the continued access for the trial as well. And I think there is that kind of looking forward to this technology coming and helping their patients here in the U.S.

What we like with this PASCAL tricuspid upcoming approval in the U.S., this is adding a layer of growth for TMTT. So we have today PASCAL mitral. We have EVOQUE still scaling. We have M3 at the beginning, and we are going to add this fourth layer of growth for TMTT. So this give us confidence. One is that physicians will have all of the tools they need, best-in-class tools they need to treat their patients, but also confidence in TMTT achieving $2 billion in 2030.

Your next question comes from Vijay Kumar with Evercore ISI.

Congrats on a nice sprint here. Bernard, it looks like in the press release, you called out EVOQUE. So I'm curious on the TMTT performance. Is -- have you seen an inflection in EVOQUE? And is that what's driving the strength? Or is this more broad-based when you look at the TMTT portfolio?

Let me make a brief comment about it, and then I will ask Daveen to add additional color here. I will say we have seen an inflection in EVOQUE since the beginning. The demand is very high. And if you -- so it's like it's growing very well. And what we have seen in the quarter is great adoption. But I'm going to let Daveen who is very close to this action.

No, I think I'll speak first a little bit more broadly. As Bernard mentioned upfront in the call to Rob's question, we've seen a growth coming across all of the platforms in TMTT, and to be honest, all the regions for TMTT. It's been great to see that all the technologies are adopted. As you can imagine, right, PASCAL was our first technology. So it's actually our largest technology by revenue. And EVOQUE though, is second in size, but growing very quickly. There's a lot of excitement for the technology. We see the continued new data coming out, people adding to the overall clinics portfolio that makes people want to use EVOQUE. And then we've got the new kid on the block, obviously, with SAPIEN M3, which is the newest high growth rate, but the smallest because it's just the newest in terms of its timing. And what we're seeing overall is that specifically if you dive a little bit into EVOQUE, we see a couple of different factors. We see us kind of deepening overall adoption coming from -- we have new centers opening up every week, every month across the world. So new centers are getting exposed to EVOQUE. We see that in existing centers. Over time, we're continuing to work closely with them to streamline the whole process of an EVOQUE patient from the pre-case plan to getting ready for that patient to actually executing the case. And that then enables those centers to actually do more cases and actually increase the kind of amount of usage in each case. So I think those together are helping keep the momentum going in EVOQUE, but I don't want to underscore the momentum we see today, both in PASCAL and the initial momentum we're seeing with M3.

That's helpful, Daveen. And maybe, Bernard, one on PROGRESS. I know there was a lot of -- it's a heterogeneous population, and you guys did a good job trying to balance out the different factors. Most of these patients had heart failure symptoms. What were the baseline drugs in this trial? Was it a consideration when randomizing? I don't know if you can answer that, but if you could talk about how drug arms in both arms -- how the drugs in both arms were -- whether they were randomized or was that a criteria?

Thanks, Vijay. I'm going to ask Dan to reply to this way. It is a technical question, Vijay. So Dan is in the best position here.

I think -- and I think this is one of the reasons why we presented the baseline characteristics and perhaps it's important for everyone to understand, this is not a heart failure trial, right? This is a trial on moderate AS patients with at-risk features. UNLOAD was a heart failure trial where the patients happen to have moderate AS. And so these are 2 very, very different patient populations. And you could see from the baseline characteristics, what's interesting about them is perhaps clinically not benign. We'll see like that these patients did have symptoms. They did have at-risk features as the trial design was intended. But they also had very healthy left ventricular function. And so this is the type of patient that we're dealing with. They're not a heart failure patient. They're a moderate AS patient with certain characteristics that may predispose them to greater risk clinically than what current guidelines suggest, which is active surveillance. And so again, a lot of learning here, understanding the patients. So drug regimens don't play into a big factor here because these patients don't have heart failure symptoms. Although the primary endpoint is going to include hospitalization and heart failure events, obviously, when you're doing a surveillance trial like this and a comparator against surveillance like this. So a lot to learn, and we'll learn more when the results are presented at TCT. Thanks for the question.

Your next question comes from Josh Jennings with TD Cowen.

First, I just wanted to talk about TAVR market growth drivers. I mean, the CMS, NCD update and the moderate indication are 2 clear ones. TAVR-in-TAVR is kind of going to pump in on the back burner, but low-risk indication was approved in 2019. So next year will be the eighth year post-approval. Edwards hasn't been very vocal about TAVR-in-TAVR as a potential driver with SAPIEN is well positioned for that procedure. Maybe could you help provide some insights on Edwards' internal expectations for the TAVR-in-TAVR opportunity and when these procedures could potentially contribute at a meaningful level to volume growth?

Yes. Maybe I -- Josh, maybe I answer that question. You're absolutely right when you talk about some of the more obvious sort of milestones ahead of us with NCD, PROGRESS, et cetera. And lifetime management, I think we've talked a lot about this. This is something that is becoming absolutely more important and more critical, particularly as the evidence suggests that you get benefit by treating earlier in the disease pathway, not just younger. I mean, earlier in the disease pathway, as we learn, can mean different things to different patients at different age groups. But the reality is, is that we anticipate as more -- as the therapy penetrates is that there are going to be patients who outlive the durability of their valve, and we're seeing that in various trials, et cetera, in various patient populations. And so lifetime management becomes a thing and the planning of when to treat with what option and how to treat the second option. And there's a lot of complexity in there. So we have modeled that into our market model. We look at that. Right now, it represents a relatively small part of the market relatively. We anticipate that to grow, and that's all factored into the TAVR market.

If you put all of this in perspective, we are, in my mind, sitting in front of an amazing opportunity. If you look at TAVR, you have -- it is still underpenetrated. It is still under adopted. We have the asymptomatic indication to unlock with the NCD. The NCD has the potential, if the drug remain like it is to streamline timely access for patients. You have -- if a study is positive, a PROGRESS study is positive, another indication for this patient population. So we look at TAVR as a very durable growth engine for the company. You add all of the catalysts we are having on TMTT, PASCAL, M3, EVOQUE and you look at Surgical also, we didn't discuss about Surgical today, but we have also many opportunities in Surgical. So altogether for TAVR and altogether for the company, we feel very confident. You look at what we did last year, what we are doing this year, the kind of execution we are having also, all of this together in my mind, it is what give us confidence about achieving long term about 10% EPS leverage and operating margin improvement, 50 to 100 points. So again, excited, confident. I like what the team is doing, and it's great to be able to report this kind of quarter.

Thank you. And ladies and gentlemen, that's all the time we have for questions today. I'll now hand the floor back to Bernard Zovighian for closing remarks.

Yes. So thank you all for your interest in the company. You know that we are available for any call, Doretta, Gerianne and myself are available. And I know that you are going to have a phone call with the team. Thank you so much, and have a great day.

Thank you. And with that, we conclude today's call. All parties may disconnect. Have a good day.