TRICURE US Pivotal Study Begins for TriCares’ Topaz TTVR System

July 10, 2026—TriCares SAS announced that the first patient has been enrolled and treated in the TRICURE United States investigation device exemption (IDE) pivotal study, which is evaluating the company’s Topaz transcatheter tricuspid valve replacement (TTVR) system in the treatment of tricuspid regurgitation (TR).

The randomized controlled study is actively enrolling patients in a head-to-head comparison of its investigational TTVR system versus the commercially available Evoque TTVR system (Edwards Lifesciences). In April, TriCares announced FDA approval of the IDE to conduct the United States trial.

According to the company, the TRICURE US pivotal study is a prospective, global, multicenter, randomized (1:1) controlled study designed to evaluate the safety and effectiveness of the TriCares Topaz TTVR system in patients with severe or greater TR who are suitable for valve replacement.

The global study will be conducted in the United States, Canada, and several European countries with up to 75 sites participating.

Vinod Thourani, MD, and Pradeep Yadav, MD, enrolled the first patient in the trial at the Piedmont Heart Institute in Atlanta, Georgia.

Dr. Thourani, who is Chairman of Cardiac Surgery at Piedmont Heart Institute, serves as Site Principal Investigator for the study. Dr. Yadav is Director of Structural Interventions at the Marcus Heart and Vascular Center at Piedmont.

Dr. Yadav serves with Neil Fam, MD, as Coprincipal Investigators of the TRICURE US pivotal study. Dr. Fam is Director Structural Heart Program at St. Michael’s Hospital, Schroeder Chair in Structural and Valve Innovation, University of Toronto in Toronto, Canada.