Press Announcements > FDA expands use of Sapien 3 artificial heart valve for high-risk patients

Press Announcements > FDA expands use of Sapien 3 artificial heart valve for high-risk patients

FDA expands use of Sapien 3 artificial heart valve for high-risk patients

06/05/2017 03:44 PM EDT

The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater.