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

|About: Edwards Lifesciences Corp (EW)|By:, SA News Editor

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.