Posted by Michael Wonder on 05 Jun 2017
FDA expands use of Sapien 3 artificial heart valve for high-risk patients
5 June 2017 - Expanded use approval relies on real world evidence.
The U.S. FDA today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve 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.
"For the first time, a regulatory agency is approving a transcatheter heart valve as a valve-in-valve treatment when bioprosthetic mitral or aortic valves fail in patients who are at high or greater risk of complications from repeat surgery," said Bram Zuckerman, M.D., director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health. "This new approval offers U.S. patients with failing surgical bioprosthetic aortic or mitral valves a less-invasive treatment option."
