FDA Grants IDE Approvals for Topaz Tricuspid Valve and TransMedics Heart Transplant Trials

The U.S. Food and Drug Administration has granted investigational device exemption approvals for two significant cardiovascular device trials, clearing the way for pivotal studies of a next-generation tricuspid valve replacement system and an advanced heart transplant preservation platform. The FDA approved an IDE to conduct a pivotal clinical trial for TRiCares' Topaz transcatheter tricuspid valve replacement system in the U.S., Canada and sites in Europe, while TransMedics received full and unconditional FDA IDE approval for its next-generation OCS ENHANCE Heart trial.

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 with an outer hourglass-shaped self-expanding stent frame that anchors the valve in the valve annulus and an inner stent frame containing the valve. This allows the outer frame to flex and change its shape with every heartbeat for a better seal in the annulus.

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 who are at increased surgical risk. First-in-human data presented in May 2025 showed significant elimination of TR to grade trace/none or mild in patients implanted with Topaz, with no patients requiring a permanent pacemaker and an average procedure time of 35 minutes.

Meanwhile, TransMedics' OCS ENHANCE Heart trial is designed as a two-part, large-scale clinical program aimed at redefining how donor hearts are preserved and optimized prior to transplantation. Part A focuses on evaluating prolonged heart perfusion using the next-generation OCS Heart System, with the goal of maintaining and potentially improving cardiac function during extended preservation times. Part B then moves into a randomized comparison, evaluating outcomes in donation after brain death hearts preserved on OCS versus those stored using traditional static cold storage.

With an expected enrollment exceeding 650 patients, the trial is positioned to generate one of the most robust clinical datasets ever assembled in heart transplantation. The trial targets standard-criteria donor hearts, not just marginal or high-risk organs, and if successful could meaningfully broaden the clinical use case for OCS Heart by extending preservation windows beyond the current four-hour limit and demonstrating superior outcomes versus cold storage.

The pivotal trial approval for Topaz was made because of the clinical progress seen in the U.S. Early Feasibility Study and the ongoing TRICURE European Pivotal Study, which is currently enrolling patients at sites across Belgium, Denmark, France, Germany, Spain and Canada. 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.