FDA approves expansion of indication for MitraClip device in mitral valve repair

Abbott has received approval from the FDA for a new, expanded indication to its MitraClip device used to repair a leaky mitral valve without open-heart surgery. Supported by the results of the landmark COAPT Trial, MitraClip is the first transcatheter mitral valve intervention therapy approved to treat select heart failure patients with clinically significant secondary, or functional, mitral regurgitation (MR).

The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) Trial investigated MitraClip for treating secondary MR, showed that MitraClip was superior to medical therapy in reducing hospitalization and death for patients with severe secondary mitral regurgitation. In the COAPT Trial, 614 symptomatic heart failure patients with moderate-to-severe or severe secondary MR were randomized to receive treatment with MitraClip plus guideline-directed medical therapy or guideline-directed medical therapy alone at 78 sites in the U.S. and Canada. The primary efficacy endpoint was all heart failure hospitalizations through two years, and the primary safety endpoint was freedom from device-related complications at one year compared to a performance goal of 88 percent.

The MitraClip transcatheter clip-based therapy, available in the U.S. since 2013 and now in a third generation of product, has been used to treat more than 80,000 patients worldwide over the last 10 years. The new, expanded indication addresses the secondary form of MR and significantly increases the amount of people with MR able to be treated with MitraClip.