VDYNE Receives FDA Approval to Initiate the TRIVITA1 IDE Pivotal Trial of Transcatheter Tricuspid Valve Replacement System

VDYNE, Inc. (“VDYNE” or “the Company”), a privately held medical device company developing next generation transcatheter valve replacement technologies, today announced that the U.S. Food & Drug Administration (FDA) has approved an investigational device exemption (IDE) for the company’s pivotal clinical trial evaluating its Transcatheter Tricuspid Valve Replacement (TTVR) system.

The IDE approval enables initiation of a U.S. pivotal study at leading clinical centers 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,” 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.”

Significant unmet clinical needs exist in the treatment of TR with 1.5 million people in the US suffering from TR with a small percentage of those patients eligible to receive surgical treatment.² Severe TR is linked to poor prognosis and high mortality (10% at one year), yet current treatment options remain extremely limited³.

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

About VDYNE, Inc.

VDYNE, Inc. is a privately held medical device company focused on developing innovative transcatheter valve replacement technologies for the treatment of tricuspid regurgitation. Headquartered in Maple Grove, Minnesota, VDYNE is dedicated to transforming care for patients suffering from right heart valve disease.

The VDYNE Tricuspid Valve Replacement System is currently under clinical investigation and not commercially available in the United States or any other country.

About Tricuspid Regurgitation

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.

[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.

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