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.
You may also be interested in...
Medicare now covers transcatheter edge-to-edge repair for both functional and degenerative mitral regurgitation under specific conditions.
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 500-patient REPAIR MR trial will evaluate Abbott’s MitraClip mitral valve repair device in patients who would face moderate risk during open heart surgery. MitraClip is currently approved only for patients who are not surgical candidates.