Edwards wins U.S. nod for next generation Sapien XT heart valve system

June 16, 2014 10:37 PM

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(Reuters) - Edwards Lifesciences Corp said on Monday that U.S. health regulators approved its next generation heart valve replacement system for high risk patients and those deemed too frail to endure open heart surgery.

The Food and Drug Administration approved the Sapien XT transcatheter aortic valve replacement (TAVR) system, Edwards said, adding that it will make the device immediately available to patients with severely diseased aortic valves.

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