Larry Wood: Sure. With regard to this [market] (ph) trial, I think we’ll just have to wait and see the trial, and we don’t know what it’s going to show. But I think the key thing is thinking about how physicians select TAVR valves for their patients. And that’s really a multi-factorial decision. I think you have to look at mortality rates, stroke, future interventions, all those things. And hemodynamics is certainly, you know, one consideration, but I don’t think it’s even a driving consideration compared to some of the other factors that are probably higher on the hierarchy for patients. In terms of the competitive space, we didn’t have a lot in 2024 because it was expected the approval was going to come late. We know it takes time to ramp a new therapy. We’ll have to see what the impact on 2025 is and what the revised approval timing is. And there’s no real value in me speculating on that.
Bernard Zovighian: Yeah. And in addition, as me being in my first year as CEO, I’d like to reflect a little bit about where we are as a company. And when I think about valve, making heart valve, it is not easy. Given the nature of patient needs, this is not luck. We are committed and focused for more than 60 years and we bring experience, a very deep knowledge. What we have seen, even in the past few years, many platforms, many companies coming in and leaving the market after a year, two years or three years. So, we are leading the space with a very significant long-term commitment, more than 2,000 engineers, R&D, R&D specialists. We are proud of our uninterrupted leadership in the space. And we are going to continue investing. So, look, for sure, we take all the competitors very seriously, but we are very confident about our leadership, about our technologies, and about our evidence.
Travis Steed: Great. And congrats again on the EVOQUE approval.
Operator: Thank you. Our next question comes from Patrick Wood with Morgan Stanley. Please state your question.
Patrick Wood: Amazing. Thank you for taking the questions. I guess maybe for the first one on TAVR in Japan, in general, do you think you’ve been taking back some share post-trialing? It sounded like you feel very good about the market, and you have taken back some share on that side. Just any color you could give there would be great.
Larry Wood: Sure. I think what happens when new technology comes into Japan, just because of the way the certification process works and people having to move through that process, that certainly had an impact for us. I think in Q4, we grew faster than the market. And I think that really relates to some of the trialing ending and people kind of moving back to our platform. But this is sort of something that goes on, but we’re very pleased with how we grew in Japan in Q4 and continue to look forward to that market growing because it’s a very — it’s a much lower penetrated market than places like the US and Europe. So we continue to see that as a long-term growth driver for us.
Patrick Wood: That’s very helpful. And then just quickly as a follow-up, I get this might be difficult to comment on, but the faster-than-expected approval of EVOQUE, what in your discussions with the FDA? And what do you think they placed a great weight on in getting it comfortable with it into market faster than expected? Do you think there was like one area of data or sense of the products because that’s obviously not been the experience for everyone? So just curious to get any thoughts there.
Daveen Chopra: Yeah. No, sure. This is Daveen again. I’ll kind of jump in this one. Obviously, we received an approval through this FDA breakthrough pathway. And this was a really innovative pathway where the basis of approval was the breakthrough cohort of the 150 patients we presented at TCT. But at the same time, as we were working with the FDAs and answering their questions, we presented and gave them other data from our larger cohort, other descriptive statistics. And as we mentioned, it’s that larger cohort where the results really showed those favorable trends in all-cause mortality, heart failure hospitalizations, tricuspid reinterventions. It was those kinds of trends that I think that we believe probably have the FDA come back to us and say, oh, yeah, this kind of makes sense.
We probably don’t need an advisory panel that led to our approval. And so, we’re very excited that the full cohort of data, the full one-year cohort on the 400 patients will be presented at TCT, so we can kind of see all the data, not just kind of the breakthrough cohort plus the initial kind of look at the other data. And that going forward, right, for us, as we launch out this therapy, we’re going to continue to have a great deal of evidence. We’re going to continue to have trials and more data that help show how great this therapy really could be for patients. We’re planning to build this therapy with really careful physician training, great clinical outcomes, and supporting this therapy just like we as an organization did for TAVR not that long ago.
And so, I’m excited really for that long-term opportunity and what this means for helping patients.
Patrick Wood: Looking forward to it. Thanks again for taking the questions.
Operator: Our next question comes from Vijay Kumar with Evercore. Please state your question.
Vijay Kumar: Hi, guys. Thanks for taking my question, and congratulations on a nice print here. Maybe on the last question on EVOQUE, Daveen, you made some comments here about the totality of data. But I’m curious on — when you think about the market development, is there like a bar, like do we need to see a stat significance in mortality? Like, there’s a reason this valve was called forgotten valve. So I’m curious what wakes up physicians to take this valve seriously, maybe compare in contrast on how this adoption curve could look like versus I don’t know if TAVR is a good example, but I would love your comments.
