FDA Policy/General

Panel Backs Abbott’s TriClip PMA

FDA’s Medical Devices Advisory Committee Circulatory System Devices Panel has voted 13 to 1 that the benefits of Abbott's TriClip transcatheter edge-to-edge repair system outweighs the risks for the treatment of people with tricuspid regurgitation (TR).

An FDA briefing document said the pivotal trial’s (TRILUMINATE) primary endpoint analysis showed “superiority of the TriClip group vs. the control group for the hierarchical composite endpoint of death or tricuspid valve surgery, number of HF hospitalizations, and a 15-point KCCQ improvement tested using the Finkelstein-Schoenfeld method, and the win-ratio point estimate was 1.44 in favor of the TriClip group.”

Abbott says the tricuspid valve “controls blood as it flows from the heart’s right atrium to the right ventricle.” TR is a condition where the valve doesn’t close properly, causing a leak and allowing blood to flow back into the heart.

Panel Backs Abbott’s TriClip PMA

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