FDA Votes in Favor of Abbott’s TriClip TEER for Tricuspid Regurgitation

Abbott announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the U.S. Food and Drug Administration (FDA) confirmed 13 to 1, with 0 abstention that the benefits of the company’s TriClip transcatheter edge-to-edge repair (TEER) system outweighed the risks to treatof people with tricuspid regurgitation (TR).
 
The FDA panel’s decision was based on data from the TRILUMINATE pivotal trial and expert testimony. The panel’s vote will be a consideration for the agency regarding TriClip’s approval. TriClip is a first-of-its-kind minimally invasive device designed to treat the heard to access tricuspid valve.
 
TriClip is delivered though a vein in the leg. Its TEER technology clips together a portion of the leaflets to repair the tricuspid valve, helping blood to flow in the right direction without needing open-heart surgery.
 
On the question of whether there’s enough data to support the device’s safety, the vote was 14 to 0 in favor. On the separate question of whether there’s reasonable assurance the device is effective, the vote was 12 to 2 in favor. On the final question of TriClip’s final benefit versus the risk, the vote was 13 to 1 in favor.
 
Abbott submitted its PMA application for TriClip to the FDA in March 2023. Abbott said the agency’s decision on TriClip is anticipated in 2024.
 
“Tricuspid regurgitation can put added strain on the heart and lead to other cardiovascular issues, which can significantly worsen a person’s quality of life, but historically there have been few treatment options,” said Lars Søndergaard, MD, chief medical officer and divisional vice president of medical affairs of Abbott’s structural heart business. “Abbott recognized the unmet need for people with this condition and explored the use of our proven clip-based technology to find a truly life-changing intervention. TriClip offers an urgently needed alternative that is safe and effective for people who require tricuspid valve repair but are not able to withstand surgery.”
 
TriClip is approved for use in over 50 countries, including in Europe and Canada.