Mike Coyle
Analyst · Mike Weinstein of JPMorgan
Sure, Mike. There wasn't much change in terms of the relative contribution of bulking versus run rate. In fact, there really wasn't any difference between those at all to speak of. What it comes down to is the product flow that we are seeing. So, on the low – power side, we are in a very virtuous product cycle right now, with the full – scan MRI labeling approval that we've received that's unique in the marketplace, as well as the fact that we showed some very interesting data around the use of reactive ATP to treat atrial fibrillation, with our Advisa MRI product line showing meaningful reductions in progression to permanent AF, as well as reductions in heart failure hospitalization, which is catching the attention of physicians. Probably most importantly was the release of the Reveal LINQ. That product has really taken off quite nicely. It offers not only the benefits relative to the old Reveal, of being a much smaller device that can be put in essentially subcutaneously quite easily, but it also allows the device to communicate to a bedside monitor on a 24 – hour basis without the patient having to interact with the device at all. And as a result, that, coupled with data from the CRYSTAL – AF study on cryptogenic stroke, has really provided a very nice catalyst and we account for those product revenues in the low – power product segment. On the high – power side, obviously, we have a different story in terms of the product cycle. We have, obviously, some pressure resulting from the presence of the quadripolar leads, now two competitors talking about quadripolar leads, whereas we are really trying to position against that with our – the AdaptivCRT algorithm that's unique to our device. That basically allows an elimination of forced R&D pacing in patients with intact AV conduction, which showed as meaningful reduction in hospitalizations for heart failure and progression in AF, which is something that we are beginning to get messaged at the HRS meeting. But we'll also, obviously, be supplementing our overall product offering with the TYRX approval that we have received, as well as we have submitted our own quadripolar lead, Performa lead, last month to FDA. The data looks excellent, and we would expect by the end of our fiscal year here, in the second half of the fiscal year, to have that approved in the US. And obviously, when you look outside the US, in places like Japan and Europe, we actually are getting very nice share traction in the high – power segment, where we have all of these products available to us. And really the US is the only place left where we don't have the quadripolar lead. So that's pretty much the status of our implantables business.