Maple Grove, Minnesota-based Vdyne develops a transcatheter tricuspid valve replacement (TTVR) system. IDE approval enables the initiation of a U.S. pivotal study to test the valve’s safety and effectiveness in severe tricuspid regurgitation (TR).

TR remains a significant unmet need, with a small percentage of patients suffering from the condition eligible for surgical treatment, the company says. It designed its TTVR system as a patient-tailored, minimally invasive solution to address the complexities of tricuspid valve anatomy and disease.