Tuesday, the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA confirmed 13 to 1, with 0 abstention, that the benefits of Abbott Laboratories (NYSE:ABT) TriClip transcatheter edge-to-edge repair (TEER) system outweighed the risks to treat tricuspid regurgitation (TR).
After reviewing data from Abbott’s TRILUMINATE pivotal trial and listening to testimony, the panel voted on the device’s safety, effectiveness, and risk/benefit profile as a treatment for TR.
On whether there is enough data to support the device’s safety, the vote was 14 to 0 in favor. On the separate question of whether there is reasonable assurance that the device is effective, the ...