TRiCares SAS has announced the successful implantation of its Topaz transcatheter tricuspid heart valve replacement (TTVR) system in the first U.S. patients as part of an Early Feasibility Study (EFS). The procedures mark a significant milestone for the company in its efforts to provide a minimally invasive solution for tricuspid regurgitation (TR).
The TRICURE EFS (NCT06506942) is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Topaz TTVR system in adult patients with severe TR who are deemed to be at increased operative risk. The study aims to enroll 15 patients across up to 8 sites in the U.S. and Canada.
The first two implantations were conducted by teams at Piedmont Heart Institute in Atlanta, GA, and the Medical University of South Carolina (MUSC) in Charleston, SC. According to TRiCares, the Topaz valve features a unique dual stent design intended for ease of implantation via transfemoral and transjugular delivery methods, avoiding the need for open-heart surgery.
Physician Perspectives
"Our first implant of the Topaz valve was successful with the patient's TR eliminated and the patient discharged in good condition shortly thereafter," said Dr. Pradeep Yadav, Director of Structural Interventions at the Marcus Heart and Vascular Center, Piedmont Heart Institute. "The simple Topaz procedure was completed in less than an hour and it was less demanding of our imaging specialists than other TR therapies."
Dr. 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."
Ongoing European Study
TRiCares is also making headway in Europe with its TRICURE EU Pivotal study. Patient enrollment is increasing, with the first implantation completed in September 2024 at the Algemeen Stedelijk Ziekenhuis hospital in Aalst, Belgium. These parallel studies in the U.S. and Europe are intended to support applications for FDA approval and CE marking.
About Tricuspid Regurgitation
Tricuspid regurgitation (TR) is a condition in which the tricuspid valve does not close properly, causing blood to flow backward into the right atrium. Severe TR can lead to heart failure and other serious complications. Current treatment options are limited, highlighting the need for innovative solutions like the Topaz TTVR system.
Protaryx Medical Completes First-in-Human Trial of Transseptal Puncture Device
In related news, Protaryx Medical has announced the completion of its first-in-human trial of a transseptal puncture (TSP) device. The trial, which enrolled five patients, met all procedural success endpoints with minimal fluoroscopic exposure and no adverse events. The device features radiofrequency guidewire technology and an extendable, echogenic, atraumatic probe, designed to simplify targeted TSP procedures.
