- Edwards Lifesciences (NYSE:EW) receives CE Mark clearance for the uses of its SAPIEN 3 transcatheter heart valve in patients with severe aortic stenosis who are at intermediate risk for an open-heart surgical procedure. The valve was originally approved in Europe in January 2014 for the same patients are at high risk for open heart surgery.
- The FDA approved the new indication last month. It was originally approved in the U.S. for high risk patients in June 2015.
- Previously: FDA OKs expanded use of Edwards' SAPIEN 3 heart valve (Aug. 18)
Expanded label for Edwards' SAPIEN 3 valve OK'd in Europe
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