Venova Medical has announced the completion of patient enrolment in the company’s VENOS-2 early feasibility study of the Velocity percutaneous arteriovenous fistula (pAVF) system for haemodialysis access.
The multicentre study is being performed under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA) and is intended to provide proof-of-concept and initial clinical safety data.
“Percutaneous AV fistulas 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,” said vascular and interventional radiologist Rishi Razdan (Jacksonville, USA), a VENOS-2 study investigator. “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.”
Erik van der Burg, CEO and co-founder of Venova Medical, added, “Our next step is to gather the necessary follow-up data and submit an IDE application to the FDA in Q2 2025 for a multicenter US pivotal trial, which will enable us to pursue US approval for the device.”
