VDyne said the Food and Drug Administration approved an investigational device exemption for a pivotal clinical trial of its transcatheter tricuspid valve replacement system. The approval, announced last week, moves VDyne a step closer to competing with Edwards Lifesciences’ Evoque tricuspid valve replacement device.

The TRIVITA trial will evaluate the safety and efficacy of the VDyne device to treat symptomatic severe tricuspid regurgitation, where the valve fails to close properly and leaks, making the heart work harder to pump blood. The artificial valve is intended to restore normal blood flow.