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.
US FDA approved Abbott Laboratories Inc.'s MitraClip transcatheter mitral valve repair system for select heart failure patients with clinically significant secondary, or functional, mitral regurgitation based on results of the COAPT trial, the company and agency announced March 14.
The approval came several months faster than Abbott predicted. During Abbott’s presentation at the Barclays Global Healthcare Conference in Miami...