TCT 2018: Abbott Expects COAPT Results To Support Expanding MitraClip's Indication
Data presented at the Transcatheter Cardiovascular Therapeutics conference Sept. 23 in San Diego will support expanding the label of Abbott's MitraClip mitral valve repair device to include secondary, or functional, mitral regurgitation, a company executive tells Medtech Insight. In the COAPT trial, MitraClip reduced the two-year rate of heart-failure hospitalization and all-cause mortality in patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation.
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In a new draft National Coverage Determination, the US Medicare agency proposes extending coverage of transcatheter mitral valve repair to certain patients with functional mitral regurgitation.
The three-year results from the COAPT trial confirm Abbott’s MitraClip transcatheter mitral valve replacement device can improve the prognosis of functional heart failure patients. A separate analysis of COAPT showed MitraClip is cost-effective compared to medical therapy.
The new indication covers functional mitral regurgitation, also known as secondary mitral regurgitation, which represents two-to-three times as many patients as the primary mitral regurgitation population MitraClip is already labeled for. The approval is supported by results from the COAPT trial, the first randomized trial to show that a mitral-valve repair could improve outcomes in patients with secondary mitral regurgitation.