FDA Approves Expanded Indication for Two Transcatheter Heart Valves for Patients at Intermediate Risk for Death or Complications Associated with Open-Heart Surgery

Silver Spring, Maryland–(ENEWSPF)–August 18, 2016.  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.

“This is the first time in the U.S. that a transcatheter…