FDA Approves Expanded Use of 'MitraClip' for Severe Heart Failure

A device called the MitraClip was introduced in 2013 to treat patients with mitral valve prolapse, and other abnormalities that does not allow one of the heart’s four valves to close properly. Doctors from Miami Cardiac & Vascular Institute took a leading role in implanting the devices to test their effectiveness.

Now, the U.S. Food and Drug Administration (FDA) has approved an expanded use for the MitraClip (pictured above) to treat patients suffering from severe and difficult-to-treat heart failure. A study last year found that these patients with so-called secondary mitral regurgitation (MR) saw greatly reduced hospitalizations and a death rate decline of nearly 40 percent.

The heart’s mitral valve provides the vital function of letting blood flow from one chamber of the heart, the left atrium, to another called the left ventricle. The MitraClip procedure is less invasive than traditional open-heart surgery, and is intended for patients who are not candidates for surgery. The device is inserted through the groin via a catheter, and advanced into the left side of the heart.

The FDA said it has broadened the approval of the heart valve repair device, which reduces moderate-to-severe or severe MR — 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. The MitraClip’s newly expanded use targets patients with normal mitral valves who develop heart failure symptoms, and moderate-to-severe or severe secondary MR — despite being treated with alternative, standard medical treatments.

Ramon Quesada, M.D., medical director of the Structural Heart and Complex Percutaneous Coronary Intervention Programs at Miami Cardiac & Vascular Institute, and the Institute have been at the forefront of MitraClip procedures for several years. Dr. Quesada, who is on the medical advisory board for Abbott Laboratories, the maker of the MitraClip, trains other interventional cardiologists on MitraClip procedures.

“This is the most positive study that we have seen in years in which an interventional procedure can improve symptoms, quality of life and survival,” said Dr. Quesada, referring to the research that led to the FDA’s approval for the MitraClips expanded use. “These patients (with secondary mitral regurgitation) are very sick.”

The study, published in the New England Journal of Medicine, involved 614 patients with secondary (MR). These patients’ mitral valves leaked, causing blood to back up into the heart and forcing the organ to work harder to circulate blood throughout the body. The mitral valve is one of four valves in the heart. It opens and closes to control blood flow between the heart’s left atrium and the left ventricle. In its statement Thursday announcing the MitraClip’s expanded approval, the FDA cited the study.

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.

“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 FDA’s 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.”