The FDA’s Circulatory System Devices advisory panel today gave a tepid endorsement to Abbott Laboratories’ MitraClip device. The panel met to evaluate use of the novel device 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.
At the end of the day, after a long and torturous discussion, the panel voted 5-3 in favor of the device, saying that the benefits outweighed the risks. The panel agreed unanimously that the device was safe (8-0) but by a narrow margin (5-4) said there was not a “reasonable assurance” that it was effective. The panel struggled over how to use the available data to identify patient groups that could benefit from the device.