The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to VDYNE, clearing the way for the company to initiate a pivotal trial of its transcatheter tricuspid valve replacement (TTVR) system for severe tricuspid regurgitation (TR) treatment.
TR, in which the tricuspid valve on the right side of the heart leaks, allowing blood to flow backwards into the right atrium with every heartbeat, represents a high unmet need.
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Research from 2022 indicates that key unmet needs for the condition, which forces the heart to work harder, often resulting in issues such as fatigue and shortness of breath, include limitations in diagnostic imaging, resulting in delayed treatment decisions and interventional steps being taken.
TR affects approximately 1.5 million people in the US, with only a small number of patients eligible for surgical treatment. Vdyne’s TTVR system takes a minimally invasive approach to treating TR, replacing the native valve using a catheter-based approach. The company’s valve replacement system comes in five sizes.
According to Vdyne, its system underwent first-in-human (FIH) use in November 2023 and has since been used globally through clinical studies and compassionate use, yielding insights into procedural performance and clinical outcomes.
Vdyne’s CEO, Mike Buck, said: “This is a defining milestone for Vdyne and an important step towards bringing a much-needed therapy to patients with severe tricuspid regurgitation.
“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.”
According to GlobalData analysis, the global TTVR market is growing at a CAGR of 28.5% and is projected to reach a valuation of around $3.7bn in 2035, up from $304.6m in 2025.
Edwards Lifesciences’ EVOQUE is currently the only TTVR system approved in the US, while Abbott’s TriClip System is approved for tricuspid valve repair rather than replacement. Each company’s system received FDA approval in 2024, while Abbott’s system secured a European CE mark in October 2023.
Another company with a TTVR system at earlier stages of clinical development is Medtronic. The Ireland-headquartered medtech giant received breakthrough device designation from the FDA in 2020 for Intrepid, a system currently being evaluated in early feasibility studies (EFS) for mitral and tricuspid valve replacement.
