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News Breaks
March 20, 2013
19:47 EDTABTFDA advisory committee votes 5-3 in favor of Abbott's MitraClip benefits
Abbott announced that the U.S. Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted Yes: 5, No: 3 that the benefits of treatment with the MitraClip device outweigh its risks in patients with significant symptomatic mitral regurgitation 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. On the separate question of whether there is reasonable assurance the device is safe, the panel voted Yes: 8, No: 0. On the question of whether there is reasonable assurance of efficacy, the panel voted Yes: 4, No: 5. The FDA will take into account the panel's advice in making its decision on whether to approve the MitraClip for the treatment of significant MR in the United States. The company expects a decision later this year.
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