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FDA Clears Edwards Sapien 3 Valve

The Food and Drug Administration Wednesday approved Irvine-based Edwards Lifesciences Corp.’s Sapien 3 less-invasive heart valve.

Sapien 3 is approved for patients with narrowing aortic heart valves who aren’t candidates for traditional open-heart surgery or those who were at high risk for complications from that surgery.

Sapien 3 is the third generation of Edwards’ original Sapien heart valve that was approved in 2011.

Edwards’ shares closed up 3% after the announcement yesterday, and were up another 3.6% in midday trading Thursday, to a $15.8 billion market cap.

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