FDA Advisory Committee recommends MitraClip (Abbott Vascular)to treat Mitral Regurgitation

The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee has on 20 March 2013, voted by majority (Yes: 5, No: 3) that the benefits of treatment with the MitraClip device from Abbott Vascular, outweigh its risks in patients with significant symptomatic mitral regurgitation (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 other international markets, is 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 allow the heart to more efficiently pump blood.