Venova’s Velocity pAVF System Pivotal Study Receives IDE Approval

August 21, 2025—Venova Medical announced FDA investigational device exemption (IDE) approval to initiate the VENOS-3 pivotal study of the company’s Velocity percutaneous arteriovenous fistula (pAVF) system.

According to Venova, the VENOS-3 prospective, multicenter, single-arm clinical study is designed to enroll up to 126 patients at up to 20 sites across the United States.

The company stated that the study, which will be initiated in Q3 2025, will gather additional evidence of the safety and effectiveness of the Velocity system to create an AVF for hemodialysis access in patients with advanced or end-stage kidney disease.

The FDA approved the study after review of the clinical outcomes and safety profile from both the VENOS-1 and VENOS-2 early feasibility studies performed with the Velocity pAVF, noted Venova.

Interventional nephrologist Neghae Mawla, MD, who is a pioneering physician in the adoption of pAVF procedures, commented on the initiation of the study in the company’s press release.

“I am excited to see the VENOS-3 pivotal study move forward,” stated Dr. Mawla. “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 hold great promise.”