ABBOTT PARK, Ill., Oct. 25, 2013 /PRNewswire/ -- Abbott today announced that its first-in-class, catheter-based MitraClip ® therapy has received U.S. Food and Drug Administration (FDA) approval and will launch immediately in the United States, providing physicians with a breakthrough treatment option for patients suffering from mitral regurgitation (MR). The MitraClip device has been approved for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. Degenerative MR is a type of MR caused by an anatomic defect of the mitral valve of the heart. Prohibitive risk is determined by the clinical judgment of a heart team due to the presence of one or more documented surgical risk factors.
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MR is a debilitating, progressive and life-threatening disease in which a leaky mitral valve causes a backward flow of blood in the heart. The condition can raise the risk of irregular heartbeats, stroke, and heart failure, which can be deadly. Mitral regurgitation is common, affecting more than 4 million Americans – nearly one in 10 people aged 75 and above. 1 Open heart mitral valve surgery is the standard-of-care treatment, but many patients are at prohibitive risk for an invasive procedure. Medications for the condition are limited to symptom management and do not stop the progression of the disease."As cardiac surgeons, we see patients with severe mitral regurgitation who we can technically operate on but who are just too frail or sick to survive mitral valve surgery with a reasonable risk and quality of life," said Michael Mack, M.D., director of Cardiovascular Research and Cardiovascular Medicine and director of Cardiovascular Surgery at Baylor Health Care System in Dallas. "With the MitraClip system, heart teams now have a catheter-based, less-invasive treatment option that can help patients who cannot withstand surgery regain their quality of life." Multiple trials, published reports, and registries of patients treated with the MitraClip device consistently demonstrate a positive safety profile, reduction in mitral regurgitation, improvement in symptoms, and reduction in hospitalizations for heart failure, even in some of the most ill and debilitated patients. More than 11,000 patients in more than 30 countries have been treated with the MitraClip device.