Abbott announces FDA voted in favor of its TriClip System

Abbott announced that the 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’s TriClip transcatheter edge-to-edge repair, or TEER, system outweighed the risks for the treatment of people with tricuspid regurgitation, or TR. The panel’s decision was based on clinical data from the TRILUMINATE pivotal trial, as well as expert testimony. The panel’s vote will be considered by the FDA when making a decision regarding the approval of TriClip, a first-of-its-kind minimally invasive device specifically designed to treat the difficult-to-access tricuspid valve. The tricuspid valve controls blood as it flows from the heart’s right atrium to the right ventricle. TR occurs when the valve doesn’t close properly, causing a leak and allowing blood to flow backward in the heart. For those who continue to have symptoms or persistent TR despite treatment with medical therapy and are not considered good candidates for surgery, TriClip represents a potentially new option that can improve a person’s quality of life. Delivered through a vein in the leg, TriClip’s TEER technology works by clipping together a portion of the leaflets – or flaps of tissue – to repair the tricuspid valve and help blood flow in the right direction without the need for open-heart surgery. 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 the question of whether there is enough data to support the safety of the device, the vote was 14 to 0 in favor. On the separate question of whether there is reasonable assurance that the device is effective, the vote was 12 to 2 in favor. On the final question of the benefit of TriClip versus the risk, the vote was 13 to 1 in favor.