FDA Approves Expanded Indication For Abbott's MitraClip Device
March 14, 2019—Abbott Structural Heart announced that the FDA has approved an expanded indication for the MitraClip transcatheter mitral valve device. The new indication is for the treatment of select heart failure patients with clinically significant secondary, or functional, mitral regurgitation (MR). The MitraClip transcatheter clip-based therapy has been available in the United States since 2013 and is now on the third generation of devices.
According to the company, the new, expanded indication addresses the secondary form of MR and significantly increases the number of patients with MR who are able to be treated with MitraClip. Based on this approval, Abbott will begin discussions with the Center for Medicare and Medicaid Services and physician specialty societies to request a revision to the national coverage determination that would expand Medicare coverage to include secondary MR patients.
Approval of the expanded indication is supported by the results of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation).
COAPT, which investigated MitraClip for treating secondary MR, met both primary and all 10 secondary endpoints, showing a 47% relative reduction in hospitalizations and a 38% relative reduction in mortality. The data were presented by Gregg W. Stone, MD, at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 21–25 in San Diego, California. The findings were simultaneously published by Dr. Stone et al in The New England Journal of Medicine (2018;379:2307–2318).
The results 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 United States and Canada. The primary efficacy endpoint was all heart failure hospitalizations through 2 years, and the primary safety endpoint was freedom from device-related complications at 1 year compared with a performance goal of 88%.
Abbott noted that the data add to more than 10 years of evidence on the use of MitraClip for treating both primary and secondary MR. Although the secondary MR indication has just been received in the United States, the device has treated patients outside of the United States with both forms of the disease.