William Plovanic: Yes, great. Thanks for taking my question. And good evening. I was wondering, just a little bit more on the LARIAT. I think that’s been a business. Have you discontinued that product in the U.S.? Is that going away? Or is that a one quarter kind of deal and then just competitively, have you seen any change in pricing or bundling strategy in terms of the penetrator device? And then, just since we’re on that, Mike, how do you think about long-term growth in the LA market today is just going to be a 50%, grower and 20%, 15% growth, 20% growth, and I’m talking about the U.S.?
Mike Carrel: I’ll start on the first one. So because I think there is three different questions in there. So the first one was about LARIAT, as you know, back several years ago, when we did the readout on the trial, while the device actually worked incredibly well for closure, it actually had better closure than any percutaneous device on the market today, and also had a great safety record in the trial. And if you recall, is a 600 patient trial, it did not meet the endpoint of reducing Afib, it reduced Afib by 4.3%. And we needed to hit about 8% in order to win the trial and have superiority. So as a result, the product has still been on the market under the 510(k) that was originally on people continue to use it but we weren’t adding any net new sites.
And so what you’re seeing now with LARIAT is we’re trying to evaluate what are next steps, we know this product is an exceptional product, it works very well. It is a product that does not get left in the bloodstream, like you do on the other percutaneous occluder market. But we’ve got to consider what are our next steps with that product, and likely would have to run a stroke trial. And I’m not saying we are going to but that would have to be the logical thing for someone to consider with it at some point in time, we’re not shutting it down because it is being used. That being said, the pressure is, as you’ve seen in this market, it’s not a lot of revenue. But as you’ve seen in this market, you’ve got new products coming on that are in trials.
So there was a product called conformal. And then also the laminar just came out. So many sites are now getting involved in new trials on the new devices that are coming out. And my – our suspicion is that you’re seeing a little bit of pressure on that, because it’s not a lot and the sites that were using our products tended to be the more advanced sites that are out there, that would tend to be part of some trials like that. So we think that’s kind of where maybe some of that pressure is happening on malaria products. We’re not promoting it, we’re not pushing the market. But we have not shut it down, either. As it relates to kind of the – kind of market dynamics, we’re seeing good consistent pricing in the market. And feel really good about that.
From that standpoint. We think it’s a – it makes a lot of sense from that standpoint. And then finally, as we look at the long-term rates for appendage management, I’m not going to give a specific number. But there’s a reason we’re running the LeAAPS trial, the LeAAPS trial is about close to tripling, maybe quadrupling the size of the overall market for people that can get their appendage managed that full 1 million patients around the globe that are undergoing cardiac surgery, we believe the LeAAPS trial will demonstrate if you put an AtriClip on those patients prophylactically or even when they’re in Afib, prophylactically in the trial, that you are going to reduce their stroke rate and their incidence of strokes. And we think that will be a big global trend that will happen once that product reads out.
That should longer-term drive significant growth on the appendage management business for a very long period of time. And so without getting a specific number, we do see that this market is less than 20% penetrated in the U.S. when you kind of calculate all those patients, and less than really between about 5% and 10% on a global basis. So a long way to go without getting a specific growth rate, though.
William Plovanic: Great, and then a follow-up if I could on EPi-Sense, is PFA been a distraction, the EPi-Sense number was great. So the question we’ve been getting asked from investors is, is PFA going to be a distraction is OCPs adopt PFA. And it makes it harder for you to kind of get in there and get those new accounts because they’re focused on getting trained on other technologies. And then on PFA, what product are you targeting, first with PFA in your own portfolio? And thanks for taking my questions.
Mike Carrel: Sure. As relates to the catheter base, PFAs, and the excitement that’s out there, as I mentioned in my comments, we think it’s actually engaging conversations, it’s allowing us to have conversations that EPi that maybe we weren’t having before, we’ve got several sites, as I mentioned, that are now actually using PFA in the conversion procedure. So it’s not actually having an impact on us in terms of getting and setting up new sites, or any kind of major distraction from that standpoint, it really actually drives good discussion and conversation around well, how would PFA work in a hybrid type setting? And so there’s a lot of discussion about that. And so, we believe that discussion and awareness is good.
Remember, PFA is an efficiency gain more than anything else, when you look at the data and the results from all those companies, CONVERGE is an efficiency gain in terms of you reduce the time that someone has to do an ablation when they go in? So you’ve got double efficiency gains, people recognize the importance of that. And that’s actually been a lot and a big part of the conversation relative to that. I know there was a second part of the conversation
