Medtronic wins FDA nod for CoreValve Evolut Pro

Medtronic (NYSE:MDT) said today it won FDA approval for its CoreValve Evolut Pro transcatheter aortic heart valve replacement designed for treating severe aortic stensosis.

The newly cleared, next-gen CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said.

“Medtronic remains committed to working with interventional cardiologists and cardiac surgeons to deliver solutions that address patient needs with the safety and performance profile they expect from Medtronic. We are excited to introduce the next evolution of our Evolut TAVR platform to provide physicians with a comprehensive portfolio to address their patients’ needs,” Medtronic heart valve therapies biz VP & GM Rhonda Robb said in a prepared release.

The clearance came backed by data from a clinical study of the Evolut Pro, which met its primary endpoint at 30 days and reported a 98.3% rate of survival and a 1.7% rate of disabling stroke, Medtronic said.

A total of 72.4% of patients in the trial experienced trace amounts of paravalvular leakage or none at all, with no incidents of moderate or severe PVL reported at 30 days.

“The 30-day clinical outcomes presented at ACC demonstrate the Evolut PRO valve to be an outstanding treatment option for patients with severe aortic stenosis who are at a high or extreme risk for surgery,” Dr. John Forrest of the Yale University School of Medicine said in a press release.

The Evolut Pro system is designed to be delivered through the EnVeo R delivery catheter system and is indicated for vessels as small as 5.5mm, Medtronic said. The CoreValve Evolut Pro is available in the US in 23mm, 26mm and 29mm sizes, the company said.

“Based on my experience implanting the Evolut PRO valve during the clinical study, I’ve been impressed by the clinical outcomes achieved in our patients This innovation represents an important advantage over previous generations of this device, as it can help assist with adequate sealing even in complex cases,” Dr. Mathew Williams of the NYU Langone Medical Center said in a prepared statement.

Last December, Medtronic said it won reimbursement and Shonin approval from the Japanese Ministry of Health, Labor & Welfare (MHLW) for its CoreValve Evolut R transcatheter aortic valve replacement.