The FDA says Edwards Lifesciences' (EW) Sapien heart valve reached its primary safety and...


The FDA says Edwards Lifesciences' (EW) Sapien heart valve reached its primary safety and effectiveness targets in a trial, but showed higher rates of strokes. The FDA will decide on Wednesday whether to approve the use of the Sapien for patients who can handle open-heart surgery; it's already authorized for those who can't.

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