Functional MR Added To FDA-Approved Indication For Abbott's MitraClip
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.
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Edwards Lifesciences is ramping up US commercialization of its Pascal Precision mitral valve transcatheter edge-to-edge repair device, the first US competitor for Abbott’s MitraClip. The FDA approved Pascal Precision earlier than the company expected, based on results of the CLASP IID trial.
The US FDA is alerting providers about a potential clip lock malfunction with Abbott’s MitraClip, a device used to treat a disorder involving the heart’s mitral valve.
Medicare now covers transcatheter edge-to-edge repair for both functional and degenerative mitral regurgitation under specific conditions.