FDA Approval of Edwards Lifesciences’ PASCAL Precision System Opens New Treatment Pathway for Patients With Tricuspid Valve Disease
The FDA approved Edwards Lifesciences' PASCAL Precision system for transcatheter tricuspid valve repair in patients with symptomatic severe tricuspid regurgitation at intermediate or greater surgical risk. The approval makes Edwards the only company offering a portfolio of repair and replacement transcatheter therapies for both the mitral and tricuspid valves in the US. The FDA also approved the PASCAL Ace with Capture Clarity system for degenerative mitral TEER, the first TEER device with fluoroscopic indicators confirming leaflet capture.
Key figures
- Drug Name
- PASCAL Precision system
- Second approval
- PASCAL Ace with Capture Clarity approved for degenerative mitral TEER
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