Venova Medical has announced the completion of patient enrollment in the company’s VENOS-2 early feasibility study of the Velocity percutaneous arteriovenous fistula (pAVF) system for hemodialysis access.
The multicenter 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, MD, from Jacksonville, Florida, 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.”
