Medtronic (NYSE:MDT) executives yesterday updated analysts on its device for treating high blood pressure, a renal denervation system called Symplicity, laying out the timetable for its hypertension program.
In renal denervation, a catheter is inserted in to the renal arteries to ablate the nerves lining those vessels, which play a role in regulating blood pressure.
Medtronic CEO Omar Ishrak told analysts during a conference call to discuss the medtech titan’s fiscal 2nd-quarter results that Medtronic expects to launch in fiscal 2014 in Europe and fiscal 2015 in the U.S.
CFO Gary Ellis said the company is advancing its renal denervation pipeline, citing the closure of the first stage of a trial of the next-generation Symplicity device in October.
"As we discussed at our analyst meeting in June, this system is expected to reduce average total ablation time from 16 minutes to 24 minutes today to 2 minutes total, and all through a 6-French catheter. We believe this product will further strengthen our leadership position in this important medtech growth market," Ellis said.
But reimbursement in Europe for the 1st-gen Symplicity is spotty, he noted, meaning revenues are growing more slowly than expected. In the U.S., Ellis said, "we continue to aggressively pursue enrollment in the Symplicity HTN-3 trial. As we’ve said in the past, this is a challenging trial to enroll. It’s turning out that we have to enroll more patients than we had expected to get to the number we want randomized. And that, at the moment, with the enrollment rates is looking like it’s going to be a challenge to get that completely enrolled by the end of the fiscal year, so this could spill into next year.
"However, we have a number of plans that we are putting in place to try to accelerate that," he said. "On the other hand, we think we can actually accelerate some of the commercialization aspects in the U.S. from the standpoint that we had originally expected there be a gap in time between FDA approval and then getting [Centers for Medicare & Medicaid] reimbursement approval. We are now trying to pursue a parallel path for those 2 which, we think, would allow us to accelerate the ramp once we get approved in the U.S."
"I would point out that because there is no separate reimbursement for renal denervation in a lot of these countries, what we’re seeing is a very high desire to do the cases but no budgets to do it," cardiac & vascular group president Michael Coyle added, saying enrollment closure for the Symplicity HTN-3 trial is slated for mid-year fiscal 2013, with U.S. approval hoped for in fiscal 2015.
"We are now focused on CE Mark studies for that and then we are working with FDA on what regulatory treatment would be for that product," Coyle said.