Edge-to-edge repair (TEER) “Pascal System” Shows Benefits in Mitral and Tricuspid Valve Repair – 1-Year Results from MiCLASP and TriCLASP Trials
Edge-to-edge repair (TEER) “Pascal System” Shows Benefits in Mitral and Tricuspid Valve Repair – 1-Year Results from MiCLASP and TriCLASP Trials
The studies were published in EuroIntervention in 2025, as highlighted by medical news sources on August 4, 2025.
1. What Is the Pascal System?
• A transcatheter edge-to-edge repair (TEER) system developed by Edwards Lifesciences.
• Used for mitral (M-TEER) and tricuspid (T-TEER) valve repair.
• Approved in Europe for both M-TEER and T-TEER.
• Approved in the U.S. by the FDA for M-TEER only (not yet for tricuspid).
2. MiCLASP Study – Mitral Valve (M-TEER) in Moderate Functional MR
• Patients: 101 with moderate functional mitral regurgitation (FMR, grade 2+)
• Results at 1 year:
• 89.8% had sustained MR reduction
• Significant improvement in quality of life and functional capacity
• Major Adverse Events (MAE): 13.9%
• Conclusion: Even moderate symptomatic FMR patients may benefit from M-TEER using the Pascal system, despite current guidelines not recommending it for this group.
3. TriCLASP Study – Tricuspid Valve (T-TEER)
• Patients: 300 with mostly severe tricuspid regurgitation (TR)
• Demographics: Average age 80.1 years; 52% women
• Results:
• 87.7% achieved at least moderate TR reduction
• MAE rates: 1.7% at 30 days; 12.7% at 1 year
• Improved:
• NYHA class
• Quality of life (KCCQ score)
• 6-minute walk distance
• 🔎 Conclusion: The Pascal system was safe and effective for T-TEER in a real-world elderly population.
4. Overall Insight
• These findings support the expanded clinical use of the Pascal Precision system in earlier-stage mitral disease and in high-risk tricuspid valve patients.
• Both studies were sponsored by Edwards Lifesciences and published in EuroIntervention.
5. According to the original studies published in JAMA and EuroIntervention, and based on current FDA and CE mark approvals:
The Pascal system is FDA-approved for use in patients with symptomatic severe primary or secondary mitral regurgitation (MR) who are not suitable for surgery.
This highlights its established role in treating severe MR, while emerging data—such as from the MiCLASP study—suggests potential safe use in earlier stages like moderate FMR, though this is not yet guideline-endorsed.
6. Although current guidelines prioritize T-TEER for patients with severe tricuspid regurgitation, emerging data from trials like TriCLASP suggest that selected patients with symptomatic moderate TR may also benefit from early transcatheter intervention.
https://eurointervention.pcronline.com/article/transcatheter-mitral-repair-in-patients-with-symptomatic-moderate-functional-mitral-regurgitation-1-year-outcomes-from-the-miclasp-study
