TRiCares has announced that the first patients have been successfully implanted with Topaz, its transcatheter tricuspid heart valve replacement (TTVR) system, in an early feasibility study (EFS) in the USA.
The TRICURE EFS, a prospective, multicentre, single-arm study approved under a US Food and Drug Administration (FDA) IDE, will assess the safety and performance of TRiCares’ Topaz TTVR system in adult patients with severe tricuspid regurgitation (TR) who are identified with increased operative risk. The study is taking place in up to eight sites across the USA and Canada, aiming to enrol 15 patients.
The first two implantations in the TRICURE EFS were carried out by the experienced teams at Piedmont Heart Institute in Atlanta and the Medical University of South Carolina (MUSC) in Charleston.
Ahmed Elmouelhi, president & CEO of TRiCares, said: “Starting the EFS study in the USA alongside the ongoing European pivotal study for CE marking is testament to the hard work of the TRiCares team and the excellent support from leading medical centres. We are positively progressing our ambition for Topaz to become the valve of choice for the millions of patients suffering from tricuspid regurgitation.”
Susheel Kodali, director of the Structural Heart and Valve Center at Columbia University/New York Presbyterian Hospital (New York, USA) and principal investigator of the TRICURE EFS study stated: “I am pleased to oversee this important TTVR study. In the months ahead, I’ll work with the study participants and organisers to investigate how Topaz might improve long-term outcomes for TR patients. Physicians are certainly in need of new solutions that address adverse events and simplify the implantation procedure.”
Pradeep Yadav, director of Structural Interventions at the Marcus Heart and Vascular Center, Piedmont Heart Institute (Atlanta, USA), commented: “Our first implant of the Topaz valve was successful with the patient’s TR eliminated and the patient discharged in good condition shortly thereafter. The simple Topaz procedure was completed in less than an hour and it was less demanding of our imaging specialists than other TR therapies.”
Yadav performed the procedure with Vinod Thourani, Marcus chief of cardiovascular surgery, Piedmont Heart Institute.
Nick Amoroso, Structural Heart & Valve Clinic and associate professor of medicine, MUSC, added: “The implantation of the Topaz valve took place as pre-planned, and we are pleased to see the patient recovering well. Given the unique advantages of Topaz that made treatment possible for this patient, we are encouraged by the valve’s performance.”
The procedure was performed alongside Nicolas Pope, cardiac surgery, MUSC.
TRiCares is also making progress in Europe, with growing patient enrolment in its TRICURE EU Pivotal study, with the first implantation completed in September 2024 at the Algemeen Stedelijk Ziekenhuis hospital, in Aalst, Belgium.
