First-in-Human Data on TTVR Device Shows Promising Results
First-in-Human Data on TTVR Device Shows Promising Results
Date: May 23, 2025 | Source: EuroPCR 2025 in oParis.
1. Device Overview:
• TriCares GmbH presented first-in-human data on its Topaz transcatheter tricuspid valve replacement (TTVR) system during EuroPCR 2025 in oParis.
• The self-expanding two-stent valve prosthesis is delivered through femoral or transjugular access to treat tricuspid regurgitation (TR).
2. Study Findings:
• Among the first 20 patients treated, TR was significantly reduced in all cases.
• No patients required permanent pacemakers, and the average procedure time was about 35 minutes.
• So far, 60 Topaz implants have been performed under clinical oversight globally.
3. Clinical Indications for TTVR:
• TTVR is considered for patients with moderate to severe tricuspid regurgitation who are:
• Symptomatic, especially with signs of right heart failure (e.g., fatigue, edema).
• At high surgical risk or not eligible for open-heart surgery.
• Experiencing progressive right ventricular dysfunction or worsening quality of life.
• Topaz and similar devices offer a minimally invasive alternative for this complex and often undertreated condition.
4. Device-Specific Insights:
• The Topaz system includes a catheter-based delivery method and a two-stent valve.
• It remains investigational and has not yet received FDA or CE mark approval.
5. Clinical Outlook:
• TriCares reports performance comparable to other TR therapies, with promising early safety and efficacy signals.
• The company is continuing its clinical trials in Europe and the U.S.
6. Expert & Industry Commentary:
• Dr. Julien Dreyfus (France) presented the data at EuroPCR.
• TriCares CEO Ahmed Elmouelhi praised clinical teams and confirmed plans for further optimization.
EuroPCR 2025 Presentation Details:
• Session: Tricuspid hotline: new devices
• Presenter: Dr. Julien Dreyfus, Centre Cardiologique du Nord, France
• Date/Time: Thursday, 22 May 2025, 08:30 – 09:30
• Late-Breaking Trials – EuroPCR 2025 https://www.pcronline.com/Courses/EuroPCR/Programme/Late-Breaking-Trials
