SILVER SPRING, Md., March 14, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration today approved a new indication for a heart valve repair device that is intended to reduce moderate-to-severe or severe mitral regurgitation, a leakage of blood backward through the mitral valve into the heart's left atrium that can cause heart failure symptoms such as shortness of breath, fatigue and swelling in the legs. When first approved in 2013, the MitraClip Clip Delivery System (MitraClip) was indicated to reduce mitral regurgitation in certain patients whose significant mitral regurgitation and heart failure symptoms result from abnormalities of the mitral valve (commonly known as primary or degenerative mitral regurgitation) and whose risks for mitral valve surgery are prohibitive. The new indication, approved today, is for treatment of patients with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation because of diminished left heart function (commonly known as secondary or functional mitral regurgitation) despite being treated with optimal medical therapy. Optimal medical therapy includes combinations of different heart failure medications along with, in certain patients, cardiac resynchronization therapy and implantation of cardioverter defibrillators.
"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."
About 6.5 million American adults live with heart failure, a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body's needs for blood and oxygen. A small percentage of these patients also have moderate-to-severe or severe secondary mitral regurgitation, increasing the risks and complicating the treatment of their heart failure. With this new approval, this small percentage of patients could be indicated as candidates for treatment with the MitraClip device when combined with optimal medical therapy.
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The MitraClip is inserted in a minimally invasive procedure 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.