Abbott Launches REPAIR MR Trial To Bring MitraClip To More Patients
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.
You may also be interested in...
Tendyne is indicated for the treatment of significant mitral regurgitation in patients who are not candidates for surgery. It complements Abbott’s MitraClip mitral valve repair device and is an important part of the company’s strategy to be the leading structural heart device company.
Abbott Laboratories’ medical device businesses grew 10.6% year over year in the third quarter of 2019 while its diagnostics business grew 6.6%, helping the company grow 7.6% overall, the company reported on 16 October.
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.