Topaz vs. Evoque: New head-to-head study for TTVR devices now underway

July 9, 2026 - 18:31

A new clinical study is now underway to directly compare two leading transcatheter tricuspid valve replacement (TTVR) systems. The trial will pit the redesigned Topaz device from TRiCares against the Evoque system from Edwards Lifesciences, which already holds FDA approval.

The study aims to evaluate safety and effectiveness in patients with severe tricuspid regurgitation, a condition where the valve fails to close properly, causing blood to flow backward into the right atrium. Both devices are delivered through a catheter, avoiding the need for open-heart surgery.

The Topaz system has undergone significant redesign, and this head-to-head comparison marks a critical step for TRiCares as it seeks to challenge Edwards' established presence in the structural heart market. The Evoque system, approved by the FDA in early 2024, has been the only TTVR device available in the United States.

Researchers will track key outcomes including valve function, heart failure symptoms, and patient quality of life over time. Enrollment is expected to take place at multiple centers across North America and Europe.

The tricuspid valve has historically been called the "forgotten valve" because it was often left untreated. But with newer devices like Topaz and Evoque, more patients now have options for minimally invasive repair. The results of this study could shape future treatment guidelines and influence which device becomes the standard of care.

Both companies have expressed confidence in their respective technologies. The trial is expected to report initial findings within the next 18 to 24 months.