Edwards Transcatheter Heart Valve Receives Expanded Indication From FDA

Edwards Lifesciences announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic stenosis who have been determined by a Heart Team to be at intermediate risk for open-heart surgery. The SAPIEN 3 valve is the first transcatheter aortic valve replacement (TAVR) therapy to obtain this indication in the United States.