VDYNE, a privately held medical device company focused on next-generation transcatheter valve replacement technologies, has announced that the US FDA has granted an investigational device exemption (IDE) for its pivotal clinical trial of the Transcatheter Tricuspid Valve Replacement (TTVR) system.

The approval clears the way for a US study at leading clinical centers to evaluate the safety and effectiveness of VDYNE’s system in patients suffering from severe tricuspid regurgitation (TR).

“This is a defining milestone for VDYNE and an important step toward bringing a much-needed therapy to patients with severe tricuspid regurgitation,” said Mike Buck, Chief Executive Officer. “Our focus now is on disciplined clinical execution and partnering with leading investigators to generate high-quality data that advances the field and improves patient care.”

TR remains a critical unmet medical need, affecting roughly 1.5 million Americans, yet only a fraction are candidates for surgical treatment. Severe TR carries a grim prognosis, with a 10% mortality rate at one year, and treatment options remain extremely limited.

VDYNE’s TTVR system is engineered as a minimally invasive, patient-tailored solution to address the complex anatomy of the tricuspid valve. Since its first-in-human use in November 2023, the system has been deployed globally in both clinical studies and compassionate use programs, generating key insights into procedural performance and patient outcomes.