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

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.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm561924.htm

Source: Food and Drug Administration - June 5, 2017 Category: American Health Source Type: news