A medical device company has received approval from the US Food and Drug Administration for a pivotal trial. The trial, called TRIUMPH, will evaluate a system for replacing the tricuspid valve in the heart using a transcatheter approach.

The system is being developed by Laplace Interventional, a company based in Minneapolis. The approval is for an Investigational Device Exemption, which allows the company to move forward with the trial.

Further details about the trial and the device are available from the company's announcement. The approval was announced on June 29, 2026, and marks a significant step forward for the company's Transcatheter Tricuspid Valve Replacement system.