March 14, 2019 - 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.

The MitraClip is inserted is 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.

The approval of the new indication is based on a study of 614 patients with heart failure who had moderate-to-severe or severe secondary mitral regurgitation and were randomly assigned to get either continuation of their optimized medication treatment plus the MitraClip (MitraClip group) or continuation of their optimized medication treatment only (control group). The risk of being re-hospitalized for heart failure symptoms was reduced by approximately 47 percent in the MitraClip group compared to the control group. In addition, the risk of death within two years was decreased by approximately 37 percent in the MitraClip group compared to the control group.

Potential adverse events from the device and implant procedure include death, stroke, major bleeding, and erratic heart beat (atrial fibrillation).

The MitraClip is contraindicated in patients who cannot tolerate blood thinners during or after the procedure, who have active inflammation (endocarditis) of the mitral valve, rheumatic mitral valve disease or evidence of blood clots in the heart or veins leading to the heart.

The MitraClip Clip Delivery System is manufactured by Abbott Vascular Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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