The Velocity System is a next generation percutaneous AVF technology designed to reduce the need for reinterventions to achieve fistula maturation and improve hemodialysis vascular access outcomes while reducing costs.
LOS GATOS, Calif., Nov. 6, 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, announced today the enrollment of the first subjects in the company's VENOS-3 pivotal study (NCT07153939) of the Velocity pAVF System. The VENOS-3 study, performed under an Investigational Device Exemption (IDE) granted by the FDA, is a prospective, multi-center, single-arm clinical trial designed to enroll up to 126 patients with advanced or end stage kidney disease at up to 40 sites across the U.S. The study is being conducted to further establish evidence of the safety and efficacy of the Velocity System to create a percutaneous arteriovenous (AV) fistula for hemodialysis access.
Initial procedures for the VENOS-3 study were recently performed by Jason Beaver, MD, a surgeon at Surgery Center South in Dothan, Alabama, and Derek Mittleider, MD, an interventional radiology specialist with Vascular & Embolization Specialists in Cocoa, Florida. "We're excited to participate in this pivotal study evaluating the Velocity next-generation percutaneous device for arteriovenous fistula creation," stated Dr. Beaver "This technology has the potential to reduce the invasiveness of the procedure, streamline access creation, and improve the patient experience — all while maintaining the durable outcomes we expect from a surgical fistula." Dr. Mittleider added "this pivotal study represents an important step in evaluating the safety, efficacy, and reproducibility of the Velocity System to create safe and effective hemodialysis vascular access. As an interventional radiologist, I'm particularly interested in confirming the ability of this technology to enable minimally invasive AVF creation in a non-hospital setting."
"Initiating enrollment in this pivotal study is an important milestone in Venova's mission to provide safe, effective and more accessible vascular access for hemodialysis. The goal of the VENOS-3 study is to generate high-quality clinical data to confirm the use of the Velocity System to create a percutaneous fistula can achieve comparable maturation rates and long-term patency to surgically created access, while potentially reducing procedural morbidity and resource utilization" said Erik van der Burg, CEO and Co-founder of Venova Medical. "We intend to utilize the results from this study as the primary clinical support for a future marketing application 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 the prospective, multi-center, single-arm VENOS-3 IDE clinical study (NCT07153939) which is evaluating the safety and feasibility of Velocity System in patients with advanced or end stage kidney disease who are candidates for arteriovenous fistulas.
For more information, visit www.venovamedical.com
Media Contact
Erik van der Burg, Venova Medical, 1 408.242.5897, [email protected], www.venovamedical.com
SOURCE Venova Medical
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