Medtronic's First Recapturable Heart Valve Receives FDA Approval
Tuesday, June 23, 2015
Medtronic plc (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the new recapturable, self-expanding CoreValve® Evolut(TM) R System. The first-and-only recapturable and repositionable device available in the U.S., the Evolut R System is approved for transcatheter aortic valve replacement (TAVR) in severe aortic stenosis patients who are at high or extreme risk for surgery. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death.