Cardiologist shares positive first-in-human data on TriCares TTVR device
TriCares GmbH, a global medtech company with offices in France, Germany, the United States and Brazil, announced the presentation of new first-in-human data on its self-expanding Topaz transcatheter tricuspid valve replacement (TTVR) system. Julien Dreyfus, MD, PhD, a cardiologist with Centre Cardiologique du Nord in France who specializes in tricuspid treatments, presented the findings at EuroPCR in Paris.
The Topaz TTVR system, built specifically to help eliminate tricuspid regurgitation (TR), includes the Topaz two-stent heart valve prosthesis and a catheter-based implantation system. The prosthesis is delivered via the femoral vein in most cases, though transjugular access is also possible, and implanted in the patient’s diseased tricuspid valve.
Dreyfus shared data on the first 20 patients treated with the Topaz TTVR system. Overall, the device was linked to a “significant elimination” of TR in all patients. No permanent pacemakers were required in this cohort, he added, and the average procedure time was approximately 35 minutes.
Cardiologist Julien Dreyfus, MD, PhD, presents new Topaz TTVR data at EuroPCR in Paris. Image courtesy of TriCares GmbH, as seen on LinkedIn.
According to TriCares, these data are comparable to other tricuspid treatments on the market today. The company plans to use these findings to help guide ongoing research in both Europe in the United States.
“We are highly encouraged by the results of this first-in-human trial,” Ahmed Elmouelhi, president & CEO of TRiCares, said in a statement. “These initial findings serve as important validation for our ongoing clinical trials for Topaz in Europe and the U.S. 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.”
The Topaz TTVR system is still investigational at this time and has not gained U.S. Food and Drug Administration or CE mark approval.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.