TRiCares Announces First Patients Successfully Implanted in TRICURE EFS Trial of Topaz Transcatheter Tricuspid Valve Replacement System

TRiCares Announces First Patients Successfully Implanted with Its Transcatheter Tricuspid Heart Valve Replacement (TTVR) System, Topaz, in U.S. Early Feasibility Study (EFS).

TRICURE EFS is a prospective, multicenter, single-arm study approved under the U.S. Food and Drug Administration (FDA) IDE, which will evaluate the safety and performance of TRiCares' Topaz TTVR System in adult patients with severe tricuspid regurgitation (TR) and increased surgical risk. The study is being conducted at up to 8 sites across the United States and Canada, with the aim of enrolling 15 patients.

The first two implants in TRICURE EFS were performed by experienced teams from the Piedmont Heart Institute in Atlanta and the Medical University of South Carolina (MUSC) in Charleston.

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TRiCares President and CEO Ahmed Elmouelhi said, "The initiation of the EFS study in the United States, along with the ongoing pivotal CE Mark study in Europe, demonstrates the hard work of the TRiCares team and the excellent support from leading medical centers. We are actively advancing our ambition to make Topaz the preferred valve for millions of patients with tricuspid regurgitation."

Susheel Kodali, Director of the Structural Heart and Valve Center at Columbia University/NewYork-Presbyterian Hospital (New York, USA) and Principal Investigator of the TRICURE EFS study, stated: "I am delighted to oversee this important TTVR research. In the coming months, I will collaborate with study participants and organizers to explore how Topaz can improve long-term outcomes for patients with TR. Physicians certainly need new solutions that address adverse events and streamline the implantation process."

Pradeep Yadav, Director of Structural Interventions at the Marcus Heart and Vascular Center, Piedmont Heart Institute (Atlanta, USA), commented: "Our first Topaz valve implantation surgery was successful, eliminating the patient's TR, and the patient was discharged in good condition shortly thereafter. The straightforward Topaz procedure was completed in less than an hour, placing fewer demands on our imaging specialists compared to other TR therapies."

Yadav performed the surgery together with Marcus, the director of cardiovascular surgery at the Piedmont Heart Institute.

"Nick Amoroso, Structural Heart and Valve Clinic and Associate Professor of Medicine, added: 'The implantation of the Topaz valve went according to plan, and we are pleased to see the patient recovering well. Given the unique advantages of Topaz that enabled this patient to receive treatment, we are encouraged by the performance of the valve.'"

The surgery was performed in collaboration with Nicolas Pope from MUSC Cardiac Surgery.

TRiCares has also made progress in Europe, with an increasing number of patient enrollments in its TRICURE EU Pivotal study, and the first implantation was completed in September 2024 at Algemeen Stedelijk Ziekenhuis hospital in Aalst, Belgium.