FDA Panel Vote Supports Benefits of Abbott’s TriClip TEER System

February 13, 2024—Abbott announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the United States FDA has voted 13 to 1 that the benefits of the company’s TriClip transcatheter edge-to-edge repair (TEER) system outweighed the risks for the treatment of people with tricuspid regurgitation (TR).

According to the company, the panel’s decision was based on data from the TRILUMINATE pivotal trial and expert testimony. Abbott explained that the panel voted on three questions:

• on whether there is enough data to support the safety of the device, the vote was 14 to 0 in favor
• on whether there is reasonable assurance that the device is effective, the vote was 12 to 2 in favor
• on the question of the benefit of TriClip versus the risk, the vote was 13 to 1 in favor

This vote will be taken into consideration by the FDA when it decides on the approval of the TriClip system. Abbott originally submitted its premarket approval application for the TriClip device in March 2023 to the FDA, and a decision on TriClips is expected later this year.

“In the TRILUMINATE pivotal trial, we found that 90% of people who received tricuspid valve repair with the TriClip implant experienced a marked improvement in the severity of their TR with unprecedented procedural safety, and their improvement in quality of life was sustained at 1 year,” commented David Adams, MD, a Coprincipal Investigator of the TRILUMINATE pivotal trial.

He continued, “The TriClip system ushers in a new era of structural therapy for patients suffering from severe tricuspid valve disease.” Dr. Adams is Chairman of the Department of Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai and Cardiac Surgeon-in-Chief of the Mount Sinai Health System, in New York, New York.

Abbott describes TriClip as a first-of-its-kind minimally invasive device specifically designed to treat the difficult-to-access tricuspid valve. Using femoral access, TriClip’s TEER technology clips together a portion of the leaflets to repair the tricuspid valve and help blood flow in the right direction without the need for open-heart surgery.

TriClip is an investigational device in the United States. It received CE Mark in 2020, and is approved for use in more than 50 countries, including in Europe and Canada.