- 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.
FDA OKs expanded use for Edwards' SAPIEN 3 heart valve
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