TRICURE US evaluates the company’s Topaz transcatheter tricuspid valve replacement (TTVR) system. The first enrollment marks the start of the first randomized controlled study to actively enroll patients in a head-to-head comparison of an investigational TTVR system versus the commercially available Edwards Evoque TTVR system.
Topaz features a unique dual-stent design and two valve sizes. It can fit into a low-profile catheter system. The catheter system passes through the femoral vein and delivers the prosthesis to the right half of the heart. There, it is released to replace a diseased tricuspid valve.
Munich, Germany–based TriCares, which also operates out of Paris and Minneapolis, won FDA IDE for Topaz in April.
The company’s U.S. pivotal study randomizes tricuspid regurgitation (TR) patients 1:1 to evaluate Topaz’s safety and effectiveness. Sites include locations in the U.S., Canada and other European locations, with up to 75 sites participating. The first enrollment took place at the Piedmont Heart Institute in Atlanta. Dr. Pradeep Yadav, the study’s co-principal investigator, conducted the treatment with Dr. Vinod Thourani.
Findings from the IDE study will build upon first-in-human data shared last year. Early clinical results compare favorably with existing TTVR treatment approaches. The company said its fast, easy-to-use procedure proves less demanding of imaging specialists.
Beyond the currently available Evoque system, Venus Medtech continues to advance its Cardiovalve TTVR device. Vdyne and JensCare also have TTVR options under development, among other potential entrants.
Commentary from TriCares officials and investigators
Ahmed Elmouelhi, president & CEO of TRiCares, said:
“Initiating our TRICURE US IDE pivotal study represents a defining moment for TRiCares following years of innovation by our dedicated team. This milestone positions us ahead of the curve in demonstrating Topaz’s transformative potential in today’s treatment paradigm. As we rapidly activate new investigative sites and build enrollment momentum – in parallel with our ongoing European pivotal study – we are moving closer to our ambition of establishing Topaz as the preferred treatment option for TR patients globally.”
Dr. Pradeep Yadav said:
“TR therapies are quickly evolving as more and more patients seek treatment – and Topaz represents a significant step forward in TR therapies – an outcome we intend to demonstrate through the U.S. pivotal study. Enrolling the first patient in the U.S. pivotal study brings hope for an improved standard of care. Topaz’s next-generation design has already improved upon existing TTVR treatments, with a procedure that is fast, exceptionally easy-to-use, and which has required few or no pacemaker implants.”
