Topaz vs. Evoque: New head-to-head study for TTVR devices now underway
TRiCares, a global medtech company, has started enrolling patients for a new head-to-head trial comparing its Topaz Transcatheter Tricuspid Valve Replacement (TTVR) System with the Evoque TTVR system from Edwards Lifesciences.
The Topaz system, built to help eliminate tricuspid regurgitation (TR), features a 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. Early data on the Topaz system was presented at EuroPCR in Paris in 2025. The Evoque TTVR system, meanwhile, first gained U.S. Food and Drug Administration (FDA) approval for the treatment of TR in 2024. It was the first medical device specifically built for TTVR to secure FDA approval.
TRICURE US IDE is an investigational device exemption (IDE) study focused on patients who present with severe or greater TR. The very first patient enrolled for the IDE study was treated by Pradeep Yadav, MD, director of structural interventions at the Marcus Heart and Vascular Center, a part of Piedmont Healthcare, in Atlanta.
“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 US pivotal study,” Yadav said in a statement. “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.”
“Initiating our TRICURE US IDE pivotal study represents a defining moment for TRiCares following years of innovation by our dedicated team,” added Ahmed Elmouelhi, president and CEO of TRiCares. “This milestone positions us ahead of the curve in demonstrating Topaz’s transformative potential in today’s treatment paradigm.
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.