The FDA has expanded the indication for the MitraClip to include heart failure patients with moderate-to-severe secondary mitral regurgitation, the agency announced March 14. Abbott’s transcatheter mitral valve repair device was approved in 2013, but only for primary mitral regurgitation.
The new indication will significantly broaden the population eligible for treatment with the device, which clips the valve’s leaflets together to reduce the backflow of blood and allow the heart to pump more efficiently. William Abraham, MD, chair of excellence in cardiovascular medicine at Ohio State University, told Cardiovascular Business for a January story there are an estimated 300,000 to 500,000 U.S. patients with secondary MR that fit the criteria of those included in the COAPT trial, which was used to support the new indication.
In COAPT, patients treated with the MitraClip plus optimal medical therapy were 47 percent less likely to be hospitalized for heart failure and 38 percent less likely to die over two years of follow-up compared to individuals treated with optimal medical therapy alone.
"Since severe secondary MR is extremely difficult to manage and associated with a poor prognosis, people have historically had few options," Neil Moat, MD, chief medical officer of Abbott's structural heart business, said in a press release. "The expanded indication of MitraClip opens new doors for these ailing patients and can improve their quality of life and chance of survival despite their complex condition."
As detailed in the recent Cardiovascular Business story, the challenge many clinicians discussed in the wake of COAPT was replicating the positive outcomes of the trial in the real world. There was some uncertainty about whether the FDA would expand the indication so soon considering another trial released before COAPT called MITRA-FR found no advantages with the device when evaluated against optimal medical therapy.
A third trial, RESHAPE HF 2, is still ongoing and some of the more cautious structural heart experts were hoping it would serve as a tie-breaker, but the FDA decided to move on the strong results of COAPT.
In its announcement, the FDA pointed out only a small proportion of the 6.5 million Americans with heart failure also have moderate-to-severe or severe mitral regurgitation.
“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 agency stated.
The FDA noted the MitraClip is contraindicated for patients who can’t tolerate anticoagulants and for those with endocarditis of the mitral valve or rheumatic mitral valve disease.
Abbott estimated two to three times the number of patients with secondary MR could benefit from the MitraClip compared to the number who have primary, or degenerative, MR. The company plans to approach physician specialty societies and CMS about expanding the national coverage determination to broaden Medicare reimbursement for the device.