FDA Advisory Committee OKs Abbott Mitral Regurgitation Device

Abbott Laboratories’ minimally invasive MitraClip device for the treatment of mitral regurgitation (MR) received a nod from a U.S. Food and Drug Administration (FDA) advisory committee. The vote was not unanimous—5 to 3—but there were enough votes to demonstrate that the committee believes the benefits of treatment with the device outweigh the risks to patients with significant symptomatic MR who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing co-morbidities would not preclude the expected benefit from correction of the MR.

Abbott’s MitraClip device, which received CE Mark in 2008 and is commercially available in Europe and certain other international markets, is classified as an investigational device in the United States. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and is designed to reduce MR by clipping together a portion of the leaflets of the mitral valve to help the heart pump blood more efficiently. According to Abbott, the heart beats normally during the procedure, and a heart-lung bypass machine is not required. By reducing MR, the therapy may allow the heart to recover from overwork and improve function, potentially halting the progression of heart failure and enabling patients to live a higher quality life. The device is marketed by Abbott’s subsidiary, Abbott Vascular.

“We appreciate the FDA’s dedication of time and resources to convene this advisory panel for MitraClip and for its review of this new and novel technology for high surgical risk patients suffering from the debilitating symptoms of significant mitral regurgitation,” said Charles A. Simonton, M.D., divisional vice president of medical affairs and chief medical officer of Abbott Vascular. “We are pleased with the outcome of today’s panel, and we look forward to continuing discussions with the agency regarding the panel’s comments.”

The committee was informed by recent clinical trial data—Everest II, Everest II High Risk, and Realism—that reportedly showed positive and consistent results for MitraClip in the treatment of high surgical risk patients. Results showed a reduction in MR, reverse left ventricular remodeling, improvement in heart failure symptoms, improvements in quality of life, and reduced rates of re-hospitalization.

The results of the Everest II High Risk trial were released earlier this month. “Patients with mitral regurgitation who are not candidates for mitral valve surgery due to risk of mortality have an unmet need for a treatment option that will reduce symptoms and improve the quality of their lives,” said D. Scott Lim, M.D., associate professor of Cardiovascular Medicine at the University of Virginia Health System in Charlottesville, Va. “The findings of the Everest II High Surgical Risk cohort suggest that treatment with the MitraClip device represents a new option that could allow these high-risk patients to return to activities they enjoy, and results in a reduction in hospitalizations for heart failure.”

Abbott Laboratories is a based in Abbott Park near Chicago, Ill. Abbott Vascular focuses on cardiac and vascular care, particularly drug eluting stents.