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.
TriCares plans to conduct the trial at up to 75 investigative sites. The study will evaluate the safety and effectiveness of Topaz in patients with severe or greater tricuspid regurgitation (TR) at increased operative risk.
With the IDE, TriCares builds on its early feasibility study in the U.S., for which it announced first-in-human data last year. Early clinical results compare favorably with existing TTVR treatment approaches. The company said its fast, easy-to-use procedure proves less demanding of imaging specialists.
TriCares becomes the latest TTVR system to advance through the IDE process, following Vdyne’s valve, which got the nod last week. If the device continues to progress, it could offer another TTVR option in a market that features the Edwards Evoque system, while Venus Medtech advances its Cardiovalve TTVR device.
Ahmed Elmouelhi, president & CEO of TriCares, said:
“Receiving FDA approval for our US IDE pivotal trial marks a significant milestone for TriCares and, most importantly, for the many patients living with tricuspid regurgitation who urgently need improved treatment options. This approval allows us to approach our investigator sites and prepare for first patient enrollments, bringing us closer to realizing our ambition of making Topaz the standard of care for patients across the US. Combined with the momentum we are seeing in our European pivotal study, Topaz has the potential to transform treatment outcomes for TR patients globally.”
