Michael Mahoney: We’ll work our way in, right, once in a while. So we’re excited for John to come in and Lauren to move out. No, excited for Lauren to go to Urology. Yes. So to answer your question, we are fully committed to the 8% to 10% organic growth CAGR over the ’24 to ’26 period that we provided in Investor Day. Absolutely no change in that outlook. And pleased with the ’23 performance, as you know, where we grew 12%. So absolutely no change to those financial goals. You know, ACURATE continues to do well in Europe. It’s a product that’s used every day by many European physicians and we’re excited about getting the larger size approved there. We are disappointed that we didn’t get ACURATE over the goal line for approval in 2024.
So at this point, we need to wait until the full data sets been followed up for a year and read out likely before the end of this year in 2024. And we’ll take it from there in terms of the US launch. But we are disappointed we’re not going to launch that really very end of this year and into next, but absolutely no change to our financial guidance that we gave at Investor Day.
Danielle Antalffy: Okay. Great. And also welcome, Jon. Sorry, I didn’t mean to leave you out. Thanks so much guys.
Jon Monson: Thanks, Danielle.
Operator: The next question comes from Travis Steed with Bank of America. Please go ahead.
Travis Steed: Hey, thanks for taking the question. Maybe one more follow-up on TAVR. Can you just remind us what the interim look was? Was that just like a six-month look at the data? Now you need to wait for one-year data for the line to separate. And curious if you think what you saw in the interim look. Are you still pretty confident that at one year? We could have a US TAVR launch? Or does this put the whole US TAVR launch at risk?
Michael Mahoney: Janar, Are you able to hear us okay?
Janarthanan Sathananthan: Yes, I can hear you loud and clear.
Michael Mahoney: Great. Dr. Sathananthan is our Chief Medical Officer, as you know, for ICT and Structural Heart. Maybe he could comment a bit.
Janarthanan Sathananthan: Yeah. I’ll take the comment just about the data. So essentially what happened in the trial was that as part of a planned interim analysis, we made the decision to await the full one-year data. It is important just to note that the accurate IDE study is still an active clinical study with active clinical follow-up. And so as a result, we cannot disclose any data related to the trial at this time. We will expect, as Mike said, a readout of the study in the second half of 2024, following a full data review.
Travis Steed: Great. Thank you.
Operator: The next question comes from Josh Jennings with TD Cowen. Please go ahead.
Josh Jennings: Good morning. Thanks for taking the questions and congratulations for a strong end of the year. Wanted to ask about the international cardiac ablation market. Boston, incredible fourth quarter, 40% plus growth. Some of your competitors delivered really strong international growth in their electrophysiology businesses as well. What’s going on in the international market? I mean, are we seeing the promise of PFA driving market expansion this early? Or is there any pricing dynamics going on? But I think it’s 20% almost market growth in internationally for cardiac ablation this year. Just wanted to get some details there and whether that could translate to PFA launches in the United States, driving market expansion, which I think you guys detailed in your Investor Day. Thanks for taking the question.
Michael Mahoney: Dr. Stein, do you want to take a shot on it?
Kenneth Stein: Yes, Josh, and thanks, Mike. I think it’s a couple of factors here, and I don’t know that I can parse out for you, you know, how much is getting contributed from each. But again, I think we just begin with the fact, right, that atrial fibrillation is an incredibly common arrhythmia. Again, as I said earlier, it is literally pandemic worldwide. I know, for instance, in the US, right, a quarter of adults over the age of 40 will experience Afib at some point in our lives. And ablation, even with legacy thermal technologies, things for us, like stable point or POLARx is incredibly effective. It’s more effective than drugs. But on a global scale, it is still really incredibly underpenetrated as a market. And much of the growth that you see, really just reflects, I think, you know, increasing realization in the cardiology community, the referring physician community, about the relative efficacy and safety of all ablation technologies.
And then you layer on top of that the promise and the data of FARAPULSE, right? And FARAPULSE, again, it takes a procedure that’s already effective. It is at least as effective. It is clearly safer. And it’s also much more efficient than thermal ablation. And so that, right, enables docs and medical centers to scale this out much better, right, and start to get into this underpenetratrated population. So maybe a long-winded answer, but the short answer is, right, it’s both a dramatically underpenetrated population to begin with, and then on top of that, you have the accelerated impact of FARAPULSE.
Josh Jennings: Appreciate it. Thank you.
Operator: The next question comes from Richard Newitter with Truist Securities. Please go ahead.
Richard Newitter: Hi. Thanks for taking the questions and congrats on a really strong finish to the year.
Michael Mahoney: Thanks.
