FDA Approves TRICURE US Pivotal Trial of TriCares’ Topaz TTVR System

April 9, 2026—TriCares SAS announced it has received investigational device exemption (IDE) approval from the FDA to conduct a pivotal clinical trial for its Topaz transcatheter tricuspid valve replacement (TTVR) system.

According to the company, the United States IDE pivotal trial, TRICURE US, will evaluate the safety and effectiveness of Topaz in patients with severe or greater tricuspid regurgitation (TR) who are at increased surgical risk. The trial will be conducted at up to 75 investigative sites in the United States, Canada, and select sites in Europe.

Pradeep Yadav, MD, and Neil Fam, MD, are Coprincipal Investigators of TRICURE US.

TriCares advised that this pivotal trial approval builds on TRICURE EFS, the United States early feasibility study, as well as on TRICURE EU, the European pivotal study, which is currently enrolling patients at sites across Belgium, Denmark, France, Germany, Spain, and Canada, with Switzerland to follow.

In May 2025, TriCares announced that data from the TRICURE first-in-human trial of the Topaz system demonstrated significant elimination of TR to grade “trace/none” (0) or grade “mild” (1+) in patients implanted with Topaz. No patients required a permanent pacemaker, and the average procedure time was 35 minutes. The findings were presented by Julien Dreyfus, MD, at the EuroPCR 2025 conference and subsequently published by Emmanuel Teiger, MD, et al in EuroIntervention.

“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 TR,” commented Dr. Yadav in the company’s press release. “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 [United States] structural heart centers, ultimately improving patient outcomes.”

Dr. Fam added, “This IDE approval is an important step forward in combating structural heart disease. TR remains significantly undertreated, and the ability to conduct a rigorous, randomized United States pivotal study with Topaz will be critical to support broad clinical adoption. The early clinical data from the United States/Canadian EFS, the Europe first-in-human, and the Europe pivotal study have been encouraging and have significantly reduced the burden of procedural imaging. I look forward to this next phase of the program.”