FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Medtronic’s Sutureless Heart Valve Performs Well in Postmarket Follow-Up

April 30, 2014

Patients implanted with Medtronic’s 3f Enable aortic bioprosthesis showed no structural valve deterioration and 93 percent freedom from valve-related mortality five years after implantation, the Minnesota device giant said Tuesday.

Patients also showed low gradients — a means of measuring uninterrupted blood flow through the prosthetic valve, the company said.

Medtronic initiated the prospective, multicenter CE mark trial in 2009, following 141 aortic valve replacement patients for five years. The study provides the longest data on a sutureless bioprosthesis ever reported, according to the company.

The valve is implanted via a less-invasive surgical technique than that traditionally used for replacing diseased, damaged or malfunctioning natural or prosthetic valves in patients with aortic valve stenosis or aortic insufficiency, the company says. Its self-expanding nitinol frame can also be folded into a small diameter and easily repositioned, if necessary. Enable is the only such valve indicated for repositioning and reimplantation, Medtronic spokesman Joey Lomicky told Device Daily Bulletin.

The lack of conventional sutures reduces cross-clamp time during the procedure, as well as time spent on a heart-lung machine that might lead to complications, Lomicky added.

Enable received the CE mark in December 2009. It is not yet available in the U.S. — Lena Freund

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