Edwards Lifesciences Corporation (EW)’s Sapien Trial Raises Bias Question Among FDA Staff

6/11/2012 8:27:33 AM

The way Edwards Lifesciences Corp. (EW) selected and categorized patients in a trial for its Sapien heart valve may have been biased, making an evaluation of the device as an alternative to open-heart surgery difficult, U.S. Food and Drug Administration staff said. The transcatheter heart valve, which can be implanted with minimal incisions, worked as well as an operation yet showed higher rates of strokes in the study, the staff said in a report posted online today. The staff said inconsistency in the trial “makes evaluation of these endpoint results difficult.”

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