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.

Vascular-Mitraclip
• Source: Abbott Laboratories, Inc.

More from Approvals

More from Policy & Regulation