FDA clears Edwards Lifesciences' SAPIEN 3 heart valve

• The FDA approves Edwards Lifesciences' (EW +2.6%) SAPIEN 3 Transcatheter Heart Valve (THV) for patients with aortic valve stenosis (narrowing) who are not candidates for surgery or who are at high risk of complications or death associated with open-heart surgery.
• SAPIEN 3 is the third generation of the SAPIEN THV that was originally approved in 2011.