TriCares Topaz TTVR System’s TRICURE EFS Begins Enrollment

January 9, 2025—TriCares SAS, which is based in Paris, France, announced that the first patients have been implanted with the company’s Topaz transcatheter tricuspid heart valve replacement (TTVR) system in an early feasibility study (EFS) in the United States.

According to the company, the TRICURE EFS is a prospective, multicenter, single-arm study approved under an FDA investigational device exemption.

The study will assess the safety and performance of the Topaz TTVR system in adult patients with severe tricuspid regurgitation (TR) who are identified with increased operative risk. The study aims to enroll 15 patients at up to eight sites across the United States and Canada, stated the company.

TriCares noted that patient enrollment is continuing in the TRICURE EU pivotal study in Europe. As previously announced, the first implantation in TRICURE EU was completed in September 2024 at Algemeen Stedelijk Ziekenhuis in Aalst, Belgium.

The Principal Investigator of the TRICURE EFS study is Susheel Kumar Kodali, MD, Director of the Structural Heart and Valve Center at Columbia University/New York Presbyterian Hospital in New York, New York.

“I am pleased to oversee this important TTVR study,” commented Dr. Kodali in TriCares press release. “In the months ahead, I’ll work with the study participants and organizers to investigate how Topaz might improve long-term outcomes for TR patients. Physicians are certainly in need of new solutions that address adverse events and simplify the implantation procedure.”

In TRICURE EFS, the first two implantations were performed at the Piedmont Heart Institute in Atlanta, Georgia, and the Medical University of South Carolina (MUSC) in Charleston, South Carolina.

Pradeep Yadav, MD, with Vinod Thourani, MD, performed the initial procedure at the Piedmont Heart Institute.

“Our first implantation of the Topaz valve was successful with the patient’s TR eliminated and the patient discharged in good condition shortly thereafter,” stated Dr. Yadav. “The simple Topaz procedure was completed in less than an hour and it was less demanding of our imaging specialists than other TR therapies.”

At MUSC, the first procedure was performed by Nick Amoroso, MD, with Nicolas Pope, MD.

“The implantation of the Topaz valve took place as preplanned, and we are pleased to see the patient recovering well,” commented Dr. Amoroso in the press release. “Given the unique advantages of Topaz that made treatment possible for this patient, we are encouraged by the valve’s performance.”