FDA panel says approval 'not appropriate' for Abbott's MitraClip

March 18, 2013

The FDA posted online a summary for the March 20 meeting regarding Abbott's Vascular MitraClip Clip Delivery System, a first-of-a-kind transcatheter mitral valve repair system. An FDA panel concluded that premarket approval "is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered." The FDA said the trial data submitted, while "interesting and important," lack "valid scientific evidence of safety and effectiveness for the MitraClip CDS for the proposed Indication for use in an inoperable MR population." The agency panel went on, "Because there are limited options for high risk inoperable and high risk mitral valve patients, the FDA has recently worked with the sponsor in a highly interactive manner to develop a new U.S. randomized controlled trial for this patient population called the COAPT Trial. In addition, the sponsor has also recently developed a European randomized trial for this patient population."