FDA approves Edwards' Pascal Precision system for tricuspid valve repair
The FDA approved Edwards Lifesciences' Pascal Precision system for transcatheter edge-to-edge repair of the tricuspid valve, announced Oct. 21, 2026. The indication is symptomatic severe tricuspid regurgitation in patients who remain symptomatic on optimal medical therapy, are at intermediate or higher surgical risk, and are judged suitable for the procedure by a multidisciplinary heart team. The approval rests on the CLASP II TR pivotal trial, with one-year results due at TCT 2026. The device was already approved for degenerative mitral regurgitation in 2022.
Why it's notable: It adds a second transcatheter edge-to-edge option for tricuspid disease alongside Abbott's TriClip, giving heart teams a choice for patients who are poor candidates for surgery. Edwards says it is now the only company offering both repair and replacement for the mitral and tricuspid valves in the US.