TRiCares has announced the presentation of data in a late-breaking session at EuroPCR 2025 (20–23 May, Paris, France) from its first-in-human trial of the Topaz transcatheter tricuspid valve replacement (TTVR) system.
Julien Dreyfus (Centre Cardiologique du Nord, Saint-Denis, France) presented 30-day post-procedural data from 20 tricuspid regurgitation (TR) patients treated with Topaz across eight specialist cardiac centres in Europe.
The TRICURE first-in-human study demonstrated significant elimination of TR in treated patients, with grade ‘none’ (0+) or ‘mild’ (1+) TR reported in all patients implanted with Topaz. In addition, zero permanent pacemakers were required due to the investigational device. The implantation procedure lasted, on average, 35 minutes.
These early clinical results from Topaz compare favourably with existing TTVR treatment approaches, with a procedure that is fast, easy-to-use, and less demanding of imaging specialists, the company has said in a press release.
“We are highly encouraged by the results of this first-in-human trial. These initial findings serve as important validation for our ongoing clinical trials for Topaz in Europe and the USA,” said Ahmed Elmouelhi, president & CEO of TRiCares. “I want to extend our sincere gratitude to the participating hospitals, the dedicated interventional teams and clinical investigators who contributed to these patient outcomes. To date, the TRiCares team has overseen 60 Topaz implantations, and we continue to work closely with clinicians to refine the procedure and technique.”
