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FDA Advisory Committee Votes Favorably On Abbott's Minimally Invasive MitraClip® Device For Patients With Significant Mitral Regurgitation Who Are Too High Risk For Surgery

About Mitral Regurgitation

Mitral regurgitation (MR) is the most common type of heart valve insufficiency, 1 affecting approximately one in 10 people aged 75 years and older. The condition occurs when the leaflets of the mitral valve do not close completely, causing blood to flow backward and leak into the left atrium of the heart during the cardiac cycle. To maintain an adequate forward flow of blood throughout the body, the heart compensates by increasing the size of the left ventricle, the main pumping chamber of the heart. This requires the heart to work harder, and may ultimately lead to irregular heartbeats, stroke, heart attack or death. MR may also lead to heart failure, a potentially deadly condition that occurs when the heart is unable to pump sufficiently to distribute blood flow to meet the needs of the body. 

About the MitraClip ® Device

Abbott's MitraClip therapy is designed to reduce MR and provide clinical and quality-of-life benefits for patients suffering from the debilitating symptoms of significant MR by clipping together a portion of the leaflets of the mitral valve. The device is delivered to the heart through the femoral vein, a blood vessel in the leg. 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 received CE Mark in 2008 and is commercially available in 30 countries, with more than 8,000 patients treated to date. The European Society of Cardiology (ESC) 2012 heart failure guidelines and the ESC/European Association for Cardio-Thoracic Surgery 2012 guidelines for the management of valvular heart disease specify the MitraClip as a treatment option for high surgical risk patients with MR. 

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