FDA’s Circulatory System Devices Advisory Committee voted 5-3 in favor of Abbott Vascular’ MitraClip percutaneous mitral valve repair device at its March 20 meeting in Gaithersburg, Md.
Specifically, the panel voted in favor of stating that the benefits of the device outweigh the risks for use of it in patients who meet the criteria specified in Abbott’s proposed indication: Percutaneous reduction of significant symptomatic mitral regurgitation (MR≥3+) in patients who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing comorbidities would not preclude the expected benefit from correction of the mitral regurgitation
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