Topaz, a transcatheter tricuspid valve replacement system, features a unique dual-stent design and two valve sizes. It can fit into a low-profile catheter system. The catheter system goes through the femoral vein and transports the prosthesis into 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, can now bring the Topaz system to a pivotal clinical trial in the U.S., Canada and select sites in Europe. The company says IDE marks a significant step toward FDA approval and U.S. commercialization.