Adults with a severely leaking tricuspid heart valve who are risky candidates for open-heart surgery now have a second catheter-based repair device in the United States. Edwards Lifesciences announced the FDA approval of PASCAL Precision on Oct. 21 for transcatheter edge-to-edge tricuspid valve repair, known as T-TEER.
The approval covers patients with symptomatic severe tricuspid regurgitation that persists despite optimal medical therapy, who are at intermediate or greater surgical risk, and whom a multidisciplinary heart team judges appropriate for the procedure. The stated goal is improving quality of life and day-to-day function.
