The FDA has approved Edwards Lifesciences' Pascal system for transcatheter edge-to-edge tricuspid valve repair (T-TEER) in patients with symptomatic severe tricuspid regurgitation. This makes Pascal the second FDA-approved T-TEER device, joining Abbott's TriClip. Edwards now stands as the only company offering a full portfolio of transcatheter repair and replacement therapies for both the mitral and tricuspid valves in the US.
A new player enters the tricuspid repair arena. The FDA has approved Edwards Lifesciences' Pascal system for transcatheter edge-to-edge tricuspid valve repair (T-TEER) in patients with symptomatic severe tricuspid regurgitation (TR) who remain symptomatic despite optimal medical therapy and carry at least intermediate surgical risk. The approval gives US clinicians a second T-TEER option alongside Abbott's TriClip.
With this clearance, Edwards becomes the only company in the US to offer a complete portfolio of transcatheter therapies — repair and replacement — for both the mitral and tricuspid valves, including its Evoque (tricuspid replacement) and Sapien M3 (mitral replacement) devices. Edwards also announced FDA clearance of the Pascal Ace with Capture Clarity system for mitral TEER, featuring a narrower profile and fluoroscopic indicators designed to simplify the leaflet grasping step.
Key Takeaways:
Why it matters: Tricuspid regurgitation is a serious and often undertreated condition. Expanding the approved device landscape gives heart teams more options to tailor minimally invasive treatment to individual patients.
