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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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.
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.
Abbott delivered solid sales growth in the second quarter of 2019, topping analyst expectations. The company reported worldwide sales of $8bn, up 2.7% with Medical Devices highlighted as a standout division, delivering 10.5% organic growth.