TriCares Topaz TTVR System Evaluated in TRICURE FIH Study

May 27, 2025—TriCares SAS recently announced the presentation of data from the TRICURE first-in-human (FIH) trial of its investigational Topaz transcatheter tricuspid valve replacement (TTVR) system.

The 30-day postprocedural data were from 20 tricuspid regurgitation (TR) patients treated with the Topaz device at eight specialist cardiac centers in Europe. The findings were presented by Julien Dreyfus, MD, in a late-breaking session at the EuroPCR 2025 conference held May 20-23 in Paris, France. Dr. Dreyfus is a cardiologist at Centre Cardiologique du Nord in Saint-Denis, France.

According to the company, the TRICURE FIH study demonstrated significant elimination of TR in treated patients, with grade “none” (0+) or “mild” (1+) TR reported in all patients implanted with the Topaz system. In addition, no permanent pacemakers were required because of the device. The average duration of the implantation procedure was 35 minutes.

TriCares stated that these early clinical results for Topaz compare favorably with existing TTVR treatment approaches, with a procedure that is fast, easy to use, and less demanding of imaging specialists.

The initial findings from the TRICURE FIH study will be used to inform the company’s ongoing TRICURE European Union (EU) pivotal study and the United States TRICURE early feasibility study (EFS), advised the company.

The beginning of the TRICURE EU study was announced in September 2024, and the company announced the commencement of enrollment in the TRICURE EFS in January 2025.