FDA OKs expanded use for Edwards’ SAPIEN 3 heart valve

The FDA approves the use of Edwards Lifesciences’ (EW +2.1%) SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Systems for the treatment of aortic stenosis (narrowing of the aortic valve restricting blood flow) in patients at low risk for surgical intervention.

The devices were previously approved for patients at intermediate or greater risk for surgery.

https://seekingalpha.com/news/3492621-fda-oks-expanded-use-edwards-sapien-3-heart-valve