Topaz TTVR System Demonstrates Superior Outcomes in First-in-Human Study: Complete or Near-Complete Tricuspid Regurgitation Elimination in All Patients

TriCaresInEuroPCR2025 Announces Its Transcatheter Tricuspid Valve Replacement (TTVR) System ---TopazPositive Data from First-in-Human TrialThe data for this study originated from Europe.Data from 20 TR patients treated with Topaz across 8 centers at 30 days post-operation.

Specific Research Data

• All patients implanted with Topaz achieved significant reflux elimination, reaching "no reflux" (grade 0+) or "mild reflux" (grade 1+).

• Postoperatively, no patients due toTopaz Requires Implantation of a Permanent Pacemaker

• The average implantation surgery time is only 35 minutes.
  

TriCaresRepresentationThis study shows thatClinical outcomes are superior to existing TTVR therapies, with its quick and easy operation placing lower technical demands on imaging specialists.。

Executive Evaluation

"We are deeply encouraged by the results of the first-in-human trial. These preliminary findings provide important validation for the subsequent clinical trials of Topaz in Europe and the United States. We sincerely thank the participating hospitals, interventional teams, and clinical researchers for their contributions to patient outcomes. To date, the TriCares team has completed 60 Topaz implants and will continue to work closely with clinicians to optimize surgical techniques."

---Ahmed Elmouelhi  President and CEO of TriCares

• External stent, designed for in-situ fixation on native tricuspid valve leaflets, can adapt smoothly to the varying shapes and sizes of patients' anatomical structures;
• The internal stent serves as the framework for the Tricares pericardial tissue valve, aiming to achieve proper valve function and long-term performance.Trileaflet Pericardial Tissue Valve isPorcine pericardium, sutured to the inner stent with more than 1000 stitches.The internal stent ensures the roundness of the valve (preventing deformation due to varying patient anatomy), allowing for optimal leaflet alignment.

TopazThe valve prosthesis adopts a secure fixation method without traumatic anchoring structures. It is also suitable for patients with annulus diameters up to 45mm, second generation.TopazValve prostheses can be applied toAnnulusPatient with 55mm。

TRiCares Founded in 2013, TRiCares SAS is an innovative medical device company headquartered in Paris, France. Its vision is to bring a percutaneous tricuspid valve replacement system to market to help patients with severe tricuspid regurgitation avoid cardiac surgery.