FDA Recommends Postponing Abbott MitraClip Approval

Law360, Washington (March 18, 2013, 6:46 PM EDT) -- U.S. Food and Drug Administration staff on Monday recommended against giving the green light to Abbott Laboratories' implantable heart device MitraClip, saying the product lacks safety and efficacy data support.

In a staff review prepared for Wednesday's circulatory system devices panel meeting, FDA recommended that the device continue to undergo clinical testing and be made available to patients for investigative purposes, but maintained the safety and efficacy data currently presented was too limited to warrant agency approval.

“FDA believes these analyses are hypotheses generating and do...
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