The US Food and Drug Administration (FDA) has expanded the indication for the MitraClip (Abbott Vascular) device to include patients with normal mitral valves who develop symptoms of heart failure and moderate-to-severe or severe mitral regurgitation due to diminished left heart function (secondary or functional mitral regurgitation) despite optimal medical therapy.
“Supported by the results of the landmark COAPT Trial, MitraClip is the first transcatheter mitral valve intervention therapy approved to treat select heart failure patients with clinically significant secondary, or functional, mitral regurgitation,” Abbott Vascular said in a news release.
MitraClip gained initial approval in the United States in late 2013 for patients with significant mitral regurgitation and heart failure symptoms due to abnormalities of the mitral valve (primary or degenerative mitral regurgitation) who are deemed at high risk for mitral-valve surgery, as reported by Medscape Medical News.
“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,” Bram D. Zuckerman, MD, director of the Division of Cardiovascular Devices at the FDA Center for Devices and Radiological Health, said in a news release.
“Careful evaluation by a team of specialists is essential to determining whether a particular patient is an appropriate candidate for this procedure,” added Zuckerman.
The COAPT Trial enrolled 614 patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation. They were randomly assigned to get either continued optimized medication treatment plus the MitraClip or continuation of their optimized medication treatment only (control group).
The trial showed that the risk of being rehospitalized for heart failure symptoms was reduced by about 47% in the MitraClip group compared with the control group. In addition, the risk of death within 2 years was decreased by roughly 37% in the MitraClip group compared with the control group.
The MitraClip is contraindicated in patients who can’t tolerate blood thinners during or after the procedure, who have active endocarditis of the mitral valve, rheumatic mitral valve disease, or evidence of blood clots in the heart or veins leading to the heart.
About 6.5 million adults in the United States have heart failure and 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 FDA said in the release.