The agency’s Circulatory System Devices Panel narrowly voted in favor of Abbott’s MitraClip transcatheter mitral valve repair system to reduce mitral regurgitation. But the discussions about the clinical evidence on the technology were complex and the panel’s support for Abbott’s PMA was not unanimous.
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...