The agency’s green light in severe tricuspid regurgitation adds the clip-based Pascal Precision system alongside Edwards’ Evoque implant for replacing the valve entirely.
According to the company, the latest approval now makes it the only manufacturer to offer transcatheter edge-to-edge repair and replacement therapies in the U.S. for both the mitral and tricuspid valves. Pascal Precision picked up its mitral regurgitation approval in 2022, while the Sapien M3 was approved for replacing that valve late last year.