FDA approves Edwards Lifesciences Pascal Precision system for tricuspid valve repair
The FDA has approved Edwards Lifesciences' Pascal Precision system for transcatheter repair of severe tricuspid regurgitation, expanding the device's use beyond mitral valve treatment.
The Pascal Precision transcatheter edge-to-edge repair system is now authorised for appropriately selected patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, following assessment by a multidisciplinary heart team.
The decision represents a new US indication for a structural heart device previously approved for mitral valve repair in 2022, offering an additional minimally invasive treatment option for eligible patients.
Field | Content |
Article Type | Approvals |
Company | Edwards Lifesciences |
Medical Device | Pascal Precision System |
Regulatory Authority | U.S. Food and Drug Administration |
Regulatory Decision | Expanded device indication approval |
New Indication | Transcatheter treatment of severe tricuspid regurgitation |
Patient Population | Appropriately selected patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy |
Patient Selection | Multidisciplinary heart team assessment |
Therapeutic Area | Cardiology; structural heart disease |
Device Category | Transcatheter valve repair system |
Procedure | Transcatheter edge-to-edge repair |
Target Valve | Tricuspid valve |
Prior Approved Use | Mitral valve repair |
Prior Approval Year | 2022 |
Clinical Evidence | Specific pivotal study outcomes were not provided in supplied summary |
Geography | United States |
Announcement Date | 21 October 2026 |
What Happened | The FDA approved an expanded indication for the Pascal Precision system to treat selected patients with severe tricuspid regurgitation. |
Why It Matters | The approval provides an additional catheter-based treatment option for patients with symptomatic tricuspid valve disease who remain affected despite medical therapy. |
Potential Impact | Eligible patients may have access to a less invasive valve repair approach following specialist heart team evaluation. |
Key Takeaway | Pascal Precision has gained a new FDA-approved tricuspid valve indication distinct from its earlier mitral valve authorisation. |
What to Watch | US availability, clinical adoption, patient selection criteria, long-term durability and real-world outcomes. |
Primary Source | Cardiovascular Business |
Primary Source URL | https://cardiovascularbusiness.com/topics/clinical/interventional-cardiology/fda-approves-pascal-precision-system-edwards-lifesciences-tricuspid-valve-repair |
Relevant Date | 21 October 2026 |
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