FDA clears way for IDE pivotal trial of the Topaz tricuspid valve replacement system
The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to conduct a pivotal clinical trial for TRiCares Topaz transcatheter tricuspid valve replacement (TTVR) system in the U.S., Canada and sites in Europe.
The Topaz system is designed to eliminate tricuspid regurgitation through a minimally invasive transcatheter delivery, while reducing the impact on cardiac electrical conduction pathways to avoid the need for permanent pacemakers.
The valve has a unique two-stent valve prosthesis. An outer hourglass-shaped self-expanding stent frame anchors the valve in the valve annulus. The inner stent frame has the valve inside of it. The flexible outer frame connects with a skirt membrane to the inner valve stent. This allows the outer frame to flex and change its shape with every heartbeat for a better seal in the annulus, which often is not a perfect circle.
"The FDA's decision to grant IDE approval for the Topaz pivotal trial underscores the strength of the clinical evidence generated to date and the compelling unmet need in tricuspid regurgitation,” Pradeep Yadav, MD, director of structural interventions at the Marcus Heart and Vascular Center, Piedmont Heart Institute, and co-principal investigator of the TRICURE U.S. pivotal trial, said in a statement. “TTVR is rapidly emerging as a preferred treatment option for symptomatic patients with TR. We have been highly impressed with Topaz’s next-generation design, which enables streamlined implantation while maintaining a strong focus on safety and adaptability across complex patient anatomies. We are extremely excited and look forward to collaborating closely with the TRiCares team to advance this important pivotal study across U.S. structural heart centers, ultimately improving patient outcomes.”
This randomized trial will include up to 75 investigative sites to evaluate the safety and efficacy of Topaz in patients with severe or greater tricuspid regurgitation (TR) who are at increased surgical risk.
"This IDE approval is an important step forward in combating structural heart disease. Tricuspid regurgitation remains significantly under treated, and the ability to conduct a rigorous, randomized U.S. pivotal study with Topaz will be critical to support broad clinical adoption. The early clinical data from the U.S./Canadian EFS, the EU FIH, and the EU pivotal study have been encouraging and have significantly reduced the burden of procedural imaging. I look forward to this next phase of the program," explained Neil Fam, MD, in a statement. He is director of the structural heart program at St. Michael’s Hospital and the Schroeder Chair in Structural and Valve Innovation at the University of Toronto, Canada, in addition to serving as co-principal investigator of the TRICURE U.S. pivotal trial.
TRiCares said the pivotal trial approval was made because of the clinical progress seen in the U.S. Early Feasibility Study (EFS) and the ongoing TRICURE European Pivotal Study, which is currently enrolling patients at sites across Belgium, Denmark, France, Germany, Spain and Canada. First-in-human data presented in May 2025 showed significant elimination of TR to grade trace/none (0) or mild (1+) in patients implanted with Topaz. No patients required a permanent pacemaker and the average procedure time was 35 minutes.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]