VDYNE Earns FDA Approval to Begin TTVR System Study

The U.S. Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to VDYNE Inc.’s TRIVITA¹ clinical trial evaluating its Transcatheter Tricuspid Valve Replacement (TTVR) system.

The IDE approval allows VDYNE to begin a U.S. pivotal study to evaluate the safety and effectiveness of the VDYNE system in patients with 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,” VDYNE CEO Mike Buck said. “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.”

Significant unmet clinical needs exist in treating TR, with 1.5 million U.S. residents suffering from the condition; a small percentage of those patients are eligible to undergo surgery.² Severe TR is linked to poor prognosis and high mortality (10% at one year), yet current treatment options remain extremely limited.³

VDYNE’s TTVR system is designed as a patient-tailored, minimally invasive solution to address the complexities of tricuspid valve anatomy and disease. Since the first-in-human use in November 2023, the system has been used globally through clinical studies and compassionate use, providing insights into procedural performance and clinical outcomes.

Tricuspid regurgitation (TR) occurs when the tricuspid valve fails to close properly, allowing blood to flow backward into the right atrium. This condition can lead to fatigue, fluid retention, and reduced quality of life and is associated with significant mortality and morbidity.

VDYNE Inc. is a privately held medical device company developing transcatheter valve replacement technologies for treating tricuspid regurgitation. The firm is headquartered in Maple Grove, Minn. The VDYNE Tricuspid Valve Replacement System is currently under clinical investigation and not commercially available anywhere in the world.

References
¹ TRIVITA Trial: VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients with Symptomatic Severe Tricuspid Valve Regurgitation
² Demir OM, Regazzoli D, Mangieri A, Ancona MB, Mitomo S, Weisz G, Colombo A, Latib A. Transcatheter Tricuspid Valve Replacement: Principles and Design. Front Cardiovasc Med. 2018 Sep 19;5:129. doi: 10.3389/fcvm.2018.00129. PMID: 30283790; PMCID: PMC6156134.
³ Kolte D, Elmariah S. Current state of transcatheter tricuspid valve repair. Cardiovasc Diagn Ther. 2020 Feb;10(1):89-97. doi: 10.21037/cdt.2019.09.11. PMID: 32175231; PMCID: PMC7044094.