Frederick Wise: Appreciate that Dan. Thanks.
Dan Brennan: Sure.
Operator: Next question comes from Larry Bison with Wells Fargo. Please go ahead.
Larry Biegelsen: Good morning. Thanks for taking the question. I’ll reiterate my congratulations at another strong quarter here. Dr. Stein, on Advent, just using the same definition of success in Advent as manifest, I think the success rate was 74%. So what differences do we need to consider between the two studies and how much do you think those differences could impact the results for FARAPULSE? And separately, what have the success rates been with RF and Cryo in previous studies when using the same criteria as Advent? Sorry for the long question. Just lastly, if FARAPULSE is numerically lower on success or efficacy versus RF and Cryo, how do you think it will impact adoption? Thanks for taking the question.
Kenneth Stein: Yeah. Sure, Larry. There’s a lot there. Let me start right, again, reinforce to everyone. The definition of “success” is very different across a lot of the trials. And Advent, I think, has the most rigorous definition of what constitutes success, frankly, compared to any trial that’s ever been done in this space, whether it’s PFA or whether it’s thermal ablation. And so specifically, right, ADVENT is a randomized trial and that requires patients to have success to have no arrhythmia recurrence, cannot continue taking antiarrhythmic drugs even at doses that had previously failed and cannot be reablated during the so-called three month blanking period after the index ablation. It also includes a very rigorous screening for asymptomatic arrhythmias, including three days of periodic Holter monitoring throughout the of course of the one-year follow-up in the study.
I think because of that, there’s really no way to make apples-to-apples comparisons across the trials. And the other thing, I’d do in terms of expectation, we’d refer everyone back to the design manuscript for the ADVENT study, which is now published online in Heart Rhythm. And this study was designed around to achieve optimal power around an assumed success rate using this definition of 65% in both the thermal and the FARAPULSE arms. And again, to remind everyone, the studies were powered for non-inferiority. And from our standpoint, then success would constitute a demonstration of non-inferiority both for safety and for efficacy.
Larry Biegelsen: Got it. Thank you so much.
Operator: Our next question comes from Travis Steed with Bank of America. Please go ahead.
Travis Steed: Hi. Congrats on a good quarter. Just maybe following up to Larry’s question, how would you frame up the commercial opportunity for FARAPULSE for the market growth and share kind of based on the various potential outcomes for ADVENT? And I think you said it the most exciting product launch in your career, but just curious how you think the commercial opportunity frames out based on how ADVENT comes out? And then curious if you’ve seen the data yet or are you still blinded to the data? Thanks.
Mike Mahoney: Yeah. We’re obviously very bullish. WATCHMAN has been a pretty amazing product launch as well. Sometimes it gets drowned out in some of these would be continued momentum in that category and the growth of that market. But FARAPULSE is very exciting for us. We’ve been investing for quite a while post-acquisition to build up manufacturing capabilities, which is the most important thing we could do to meet the demand that we’re seeing in Europe and in certain countries in Asia-Pac. So we’re very pleased with that milestone. And as I commented earlier, expect to drive a number of new installs in the fourth quarter. I also mentioned just the ongoing increase in utilization. So the physicians who are using that in Europe and selected markets in Asia continue to drive more usage of it, which really is a terrific sign, very similar to what we saw with WATCHMAN throughout that progress.
