Abbott’s MitraClip Gets a Date with the FDA

The FDA’s Circulatory System Devices Panel will review data and make recommendations on Abbott’s MitraClip aortic valve repair system.

Abbott (NYSE:ABT) landed an FDA panel date to review its MitraClip aortic valve repair system, according to an FDA notice.

The federal watchdog agency’s Circulatory System Devices Panel will meet on March 20, 2013 to review information on and make recommendations regarding potential regulatory approval for the MitraClip system, which is intended to treat patients with mitral valve regurgitation.

The system is comprised of a delivery catheter, a steerable sleeve and the MitraClip percutaneous mechanical clip. Abbott hopes to win indication to reduce significant, symptomatic mitral regurgitation in patients too sick to undergo open-heart surgery.