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

The FDA says Edwards Lifesciences' (NYSE: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.