Venova Completes Enrollment in VENOS-2 Early Feasibility Study of Velocity pAVF System

April 17, 2025—Venova Medical announced the completion of patient enrollment for the company’s VENOS-2 early feasibility study.

According to the company, the multicenter VENOS-2 study is providing proof of concept and initial clinical safety data for Venova’s Velocity percutaneous arteriovenous fistulas (pAVF) system, which is designed to enable a minimally invasive approach for the creation of an AV fistula for hemodialysis vascular access. The study is being conducted under an FDA investigational device exemption (IDE).

In January 2025, the company announced the commencement off enrollment in VENOS-2.

Rishi Razdan, MD, who serves as an investigator for the VENOS-2 study, commented on the device and the study in the company’s press release. Dr. Razdan, a vascular and interventional radiologist specializing in dialysis access management, is Medical Director of Azura Vascular Care Jacksonville in Jacksonville, Florida.

“pAVFs provide a minimally invasive alternative to surgically created fistulas and potentially a shorter time to fistula maturation, reducing the exposure to and risks associated with hemodialysis catheters,” commented Dr. Razdan. “The Velocity system is designed to be intuitive and facilitate the user’s ability to rapidly create an AV fistula with minimal learning curve and limited need for additional procedures to achieve fistula maturation. I look forward to seeing the final clinical data from the VENOS-2 trial and participating in planned future studies with the device.”

In the press release, Erik van der Burg, who is the CEO and cofounder of Venova Medical, advised that the company will gather the follow-up data and submit an IDE application to the FDA in Q2 2025 for a multicenter United States pivotal trial to pursue FDA approval for the device.