VENOS-3 Pivotal Study Begins for Venova’s Velocity pAVF System

November 6, 2025—Venova Medical announced the enrollment of the first patients in the VENOS-3 pivotal study of the company’s Velocity percutaneous arteriovenous fistulas (pAVF) system.

According to the company, the VENOS-3 study is a prospective, multicenter, 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 United States.

The study, which is conducted under an FDA investigational device exemption, is intended to further establish evidence of the safety and efficacy of the Velocity system to create a pAVF for hemodialysis access.

The company advised that the 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,” commented Dr. Beaver in Venova’s press release. “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 nonhospital setting.”