The U.S. Food and Drug Administration (FDA) approved a new indication for MitraClip (Abbott Vascular) on Thursday, several months after COAPT trial results showed that the device plus optimal medical therapy was a significantly more effective treatment for patients with heart failure (HF) and moderate to severe secondary mitral regurgitation (MR) than optimal medical therapy alone was.
Those trial results were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2018 in San Diego in September and were published in December in the New England Journal of Medicine.
When first approved in 2013, the MitraClip Clip Delivery System was indicated to reduce mitral regurgitation in patients with primary MR and whose risks for mitral valve surgery are prohibitive. The new indication, approved Thursday, is for treatment of patients with HF and secondary MR despite being treated with optimal medical therapy, the FDA said in a news release.
“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 in the FDA’s Center for Devices and Radiological Health, said in the news release. “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 HF. A small percentage of these patients also have moderate-to-severe or severe secondary MR, increasing the risks and complicating the treatment of their HF. With the 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.
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.
COAPT trial results showed that 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 atrial fibrillation, according to the FDA.
The MitraClip is contraindicated in patients who cannot tolerate blood thinners during or after the procedure, who have endocarditis of the mitral valve, rheumatic mitral valve disease, or evidence of blood clots in the heart or veins leading to the heart.