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.
The catheter-based MitraClip device is designed to slip over the mitral valve leaflets of patients without opening their chests, minimizing recovery time drastically compared to traditional open heart surgery.
Performed under general anesthesia, MitraClip’s guide catheter is inserted into the femoral vein to reach the heart, making it ideal for patients unable to undergo surgery.
In January 2012 Abbott released results from the high-surgical-risk arm in the Everest II trial, showing improved clinical symptoms, left ventricular reverse remodeling and reduced mitral regurgitation at 12 months.
The healthcare giant more recently released results from a study observing MitraClip outcomes in "real world" patients, touting positive results for reducing mitral valve regurgitation among the older, sicker population.