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FDA approves new use for Edwards' Sapien 3 heart valve
June 5, 2017 / 7:32 PM / 5 months ago

FDA approves new use for Edwards' Sapien 3 heart valve

June 5 (Reuters) - The U.S. Food and Drug Administration on Monday approved Edwards Lifesciences Corp’s Sapien 3 artificial heart valve for high-risk patients whose previously implanted heart valves are failing, a procedure designed to avoid repeat open heart surgery.

The product is already approved as an alternative valve replacement procedure for patients at intermediate or high risk of death or severe complications from open heart surgery. (Reporting by Toni Clarke in Washington; Editing by Jonathan Oatis)

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