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FDA approves Pascal Precision system from Edwards Lifesciences for tricuspid valve repair
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Fusion42 · 21 October 2026 · Fusion42 review
The FDA has approved Edwards Lifesciences' Pascal Precision system for tricuspid valve repair, expanding its use beyond mitral valve procedures to treat symptomatic severe tricuspid regurgitation. Additionally, the FDA approved the Pascal Ace with Capture Clarity system for degenerative mitral transcatheter edge-to-edge repair, featuring improved procedural indicators.
This Wire brief sits within Fusion42's coverage of Medtech, and 3 sources have reported it between 21 Oct 2026 and 22 Oct 2026.
◆ ◆ The Wire takeaway
You now have FDA clearance to expand therapies into tricuspid valve repair using the Pascal system, opening a new patient segment beyond mitral repair. This expansion offers a pathway to target clinicians seeking advanced, less invasive treatment options in structural heart disease.
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3 sources · first reported 21 Oct 2026 · latest 22 Oct 2026
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