FDA approves expanded use for Abbott's MitraClip
Originally approved in 2013 for patients with mitral valve abnormalities who are not suitable for mitral valve surgery, Abbott's MitraClip was given the FDA ok for expanded use today. The expanded usage will now include patients with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation due to diminished left heart function after failing optimal medical therapy.
The expanded approval was in due in part to a 78 site, 614 patient trial looking at the safety and benefits for patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy.
The patients were randomized to either transcatheter mitral-valve repair plus medical therapy or the control group, medical therapy alone. The primary endpoint measuring effectiveness was all hospitalizations for heart failure within 24 months of follow-up. From a safety perspective, the primary endpoint was achieving any device-related complications at 12 months, with the performance goal of 88%.
The annualized rate of all hospitalizations for heart failure within 24 months was 35.8% in the device group compared to the control group with 67.9% per patient
From a safety perspective, the rate of freedom from device-related complications at 12 months was 96.6%. The death rate from any cause within 24 months occurred in 29.1% of the patients in the device group as compared with 46.1% in the control group.
What is Abbott's MitraClip?
The MitraClip is inserted through the femoral vein in the leg and guided into the heart's left ventricle where it grasps the two leaflets of the mitral valve, clipping them together to reduce the backflow of blood.
"Expanding the approval of this device to heart failure patients with significant secondary mitral regurgitation, who have failed to get symptom relief from other therapies, provides an important new treatment option," said Bram D. Zuckerman, M.D, director of the Division of Cardiovascular Devices in the Center for Devices and Radiological Health. "Careful evaluation by a team of specialists is essential to determining whether a particular patient is an appropriate candidate for this procedure."