FRIDAY, March 15, 2019 — A new indication has been approved for the MitraClip Clip Delivery System in patients with normal mitral valves who develop heart failure symptoms and secondary or functional mitral regurgitation despite treatment with optimal medical therapy, the U.S. Food and Drug Administration announced yesterday.
In 2013, the MitraClip was approved to reduce moderate-to-severe or severe mitral regurgitation in patients with heart failure symptoms and primary or degenerative mitral regurgitation who had prohibitive risks for mitral valve surgery. In the announcement, the FDA said the new indication approval is for patients with secondary or functional mitral regurgitation who have been treated with a combination of different heart failure medications as well as cardiac resynchronization therapy and implantation of cardioverter defibrillators.
Approval of the new indication was based on data from 614 patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation. Patients were randomly assigned to either continue optimized medication treatment only or to continue optimized medication treatment and undergo a procedure to have the MitraClip inserted. Compared with patients who continued with optimized treatment only, those treated with the MitraClip had a 47 percent reduction in the risk for rehospitalization for heart failure symptoms. Their risk for death within two years was reduced by approximately 37 percent compared with the control group.
Adverse events reported after implantation of the device included death, stroke, major bleeding, and atrial fibrillation. The MitraClip is contraindicated in patients who cannot tolerate blood thinners and those who have endocarditis of the mitral valve, rheumatic mitral valve disease, or evidence of blood clots. The MitraClip is manufactured by Abbott Vascular Inc.
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Posted: March 2019