Medtronic Gets FDA Approval for Aortic Valve Replacement System

Medtronic has been granted FDA clearance of the CoreValve Evolut R 34 mm valve – the largest transcatheter aortic valve replacement system available in the U.S.

The device valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm.

The CoreValve Evolut R 34 mm valve is currently not approved in Europe and other countries. — Cynthia Jessup