FDA approves Edwards Lifesciences’ PASCAL Precision system for tricuspid valve repair
EW•The FDA approved Edwards Lifesciences’ PASCAL Precision system for tricuspid valve repair in patients with symptomatic severe tricuspid regurgitation and cleared PASCAL Ace with Capture Clarity for degenerative mitral valve repair.
1. FDA approvals and clearance
The FDA approved Edwards Lifesciences’ PASCAL Precision system for tricuspid valve repair in patients with symptomatic severe tricuspid regurgitation. The agency also cleared PASCAL Ace with Capture Clarity for degenerative mitral valve repair; the system adds fluoroscopic indicators to confirm leaflet capture.
