FDA expands indication for two transcatheter aortic valves

Editor's Note

The Food and Drug Administration (FDA) on August 18 approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic stenosis.

The new indication is for patients who are at intermediate risk for death or complications associated with open-heart surgery.

Previously, these devices were only approved in patients at high or greater risk for death or complications during surgery.

The U.S. Food and Drug Administration today approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk for death or complications during surgery.