Dive Brief:
- 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.
- VDyne said there is a significant unmet need for minimally invasive tricuspid regurgitation treatments, noting most of the 1.5 million patients in the U.S. with the condition are too frail for open heart surgery. Tricuspid valve surgery is associated with high mortality and poor outcomes, the company added.
Dive Insight:
Edwards’ Evoque is the only FDA-authorized transcatheter replacement device for tricuspid regurgitation, having received approval in 2024.
Medtronic is evaluating a transcatheter valve replacement system called Intrepid in an early feasibility study for tricuspid regurgitation treatment.
Abbott sells the TriClip device for repairing the tricuspid valve in a minimally invasive procedure. While transcatheter tricuspid valve repair is generally considered a less risky procedure than minimally invasive valve replacement, not all leaky tricuspid valves can be repaired.
VDyne said the IDE approval enables initiation of a U.S. pivotal study at leading clinical centers. Last month, the company named Mike Buck, formerly the CEO of Verge Medical, as its chairman and chief executive.
