SAN DIEGO, Sept. 23, 2018 /PRNewswire/ -- Abbott (NYSE :ABT ) today announced positive clinical study results from a randomized controlled trial comparing treatment with the MitraClip® device to guideline-directed medical therapy in select patients with secondary (or functional) mitral regurgitation, or a leaky heart valve, as a result of advanced heart failure. The landmark COAPT study met both the primary safety and efficacy endpoints and all secondary endpoints, and showed treatment with MitraClip plus medical therapy was superior to medical therapy alone in reducing rates of heart failure hospitalizations and improving survival at two years. This therapeutic mitral valve intervention is the first and only to demonstrate positive outcomes in a clinical trial for ailing heart failure patients with clinically significant secondary mitral regurgitation.

The data were presented during a late-breaking session at the 30th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation in San Diego, and were simultaneously published in The New England Journal of Medicine. The COAPT study data will be submitted to the U.S. Food and Drug Administration (FDA) to support consideration of an expanded indication for Abbott's MitraClip to treat secondary mitral regurgitation.

"These highly anticipated results from the COAPT trial are quite remarkable, and conclusively demonstrate that heart failure patients with clinically significant secondary mitral regurgitation who remain symptomatic despite best medical practices benefit from treatment with MitraClip," said Gregg W. Stone, M.D., co-principal investigator of the COAPT study, director of cardiovascular research and education at NewYork-Presbyterian/Columbia University Irving Medical Center and professor of medicine at Columbia University Vagelos College of Physicians and Surgeons. "These results have the potential to transform clinical practice and help patients who otherwise have an extremely poor prognosis – patients who, to date, have had to rely only on medications to manage their symptoms without treating the underlying cause."
MitraClip repairs the mitral valve without the need for an invasive surgical procedure and is delivered to the heart through the femoral vein, a blood vessel in the leg. The device works by clipping together a portion of the leaflets of the mitral valve to reduce the backflow of blood, which allows the heart to pump blood more efficiently, thereby relieving symptoms and improving patient quality of life. The device was approved by the FDA in 2013 to treat the primary (or degenerative) form of mitral regurgitation (MR), which is caused by an anatomic defect of one or more of the structures of the mitral valve, which prevents the valve from closing properly, and subsequently causes leakage. Approximately one in 10 adults age 75 and older in the U.S., or four million Americans, suffer from MR.1,2,3,4

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