Venova Medical Receives FDA IDE Approval for the VENOS-3 Study
LOS GATOS, Calif., Aug. 21, 2025 /PRNewswire-PRWeb/ -- Venova Medical, a privately held company developing a next generation technology for the creation of percutaneous arteriovenous fistulas (pAVF) for hemodialysis access, today announced approval from the US Food and Drug Administration (FDA) to initiate its Multicenter Pivotal Study of the Velocity™ Percutaneous Arterio-Venous Fistula System (VENOS-3). The IDE approval enables the Company to commence the VENOS-3 study to gather further evidence of the safety and effectiveness of the Velocity System to create an arterio-venous (AV) fistula for hemodialysis access in patients with advanced or end stage kidney disease.
The VENOS-3 study is a prospective, multi-center, single-arm clinical study designed to enroll up to 126 patients at up to 20 sites across the U.S. The study will be initiated in Q3 2025. The FDA approved the study following review of the clinical outcomes and safety profile from both the VENOS-1 (NCT05757726) and VENOS-2 (NCT06712251) Early Feasibility Studies performed with the Velocity pAVF.
Neghae Mawla, MD, FASDIN, an interventional nephrologist and a pioneering physician in the adoption of pAVF procedures commented, "I am excited to see the VENOS-3 pivotal study move forward. While our experience to date with percutaneous AVFs has demonstrated their value as a minimally invasive option for creating hemodialysis access, the potential benefits of the Velocity System over current techniques holds great promise."
"This is another significant milestone for Venova Medical as we continue to develop the Velocity System as a non-surgical option for the creation of arteriovenous access for patients with advanced chronic end-stage kidney disease," stated Erik van der Burg, CEO and Co-founder of Venova Medical. "We are thrilled with the results from our first two clinical studies and the approval to begin our VENOS-3 pivotal study which will be the primary clinical support for a future marketing approval submission to the FDA."
About Venova Medical
Venova Medical, Inc. is a privately held company addressing the challenges associated with providing optimal vascular access for patients needing hemodialysis. The company has developed the Velocity System, a next generation percutaneous AVF technology designed to reduce the need for reinterventions to achieve fistula maturation and improve vascular access outcomes while reducing costs. The company is currently conducting clinical studies evaluating the safety and feasibility of Velocity System in patients with advanced and end-stage kidney disease who are candidates for arteriovenous fistulas.
Media Contact
Erik van der Burg, Venova Medical, 1 408.242.5897, [email protected], www.venovamedical.com
SOURCE Venova Medical
Share this article