FDA staff does not recommend approval of Abbott’s heart device

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A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring(Reuters) – Staff reviewers for the Food and Drug Administration did not recommend the approval of Abbott Laboratories' implantable heart device MitraClip, citing a lack of "valid scientific evidence" of safety and effectiveness. FDA reviewers said in briefing documents, posted on the regulator's website on Monday, that approval of the device would not be appropriate at the time as major questions of safety, efficacy and overall benefit-risk profile remained unanswered. …

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