The FDA approved Edwards Lifesciences' PASCAL Precision system for patients with symptomatic severe tricuspid regurgitation who remain symptomatic despite optimal medical therapy and face elevated surgical risk. The approval was backed by 1-year data from the CLASP TR trial showing significant, durable improvements. The company also received FDA approval for a new mitral valve repair system featuring fluoroscopic leaflet-capture indicators.
The FDA has approved Edwards Lifesciences' PASCAL Precision system for tricuspid valve repair, offering a new transcatheter option for patients with symptomatic severe tricuspid regurgitation (TR) who haven't responded to optimal medical therapy and are at elevated surgical risk. The decision marks a meaningful step forward for a patient population with historically limited treatment options.
The approval was grounded in 1-year results from the CLASP TR trial, which demonstrated significant improvement in TR severity and durable outcomes. Edwards also announced that 1-year data from the larger CLASP IITR pivotal trial will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in November, potentially adding further weight to the evidence base.
In a separate but related announcement, the FDA also approved the PASCAL Ace with Capture Clarity system for degenerative mitral transcatheter edge-to-edge repair (M-TEER). This system introduces fluoroscopic indicators to confirm when mitral valve leaflets have been successfully grasped — a step that can be technically challenging.
Key Takeaways:
Why it matters: Tricuspid regurgitation is often undertreated due to the high surgical risk in affected patients. This FDA approval expands minimally invasive options for a vulnerable population, while the new mitral system's leaflet-capture technology could improve procedural confidence and outcomes for structural heart teams.
