Venova Begins VENOS-2 EFS of Velocity pAVF System

January 21, 2025—Venova Medical recently announced the enrollment of the first patients in the company’s VENOS-2 early feasibility study of its Velocity percutaneous arteriovenous fistula (pAVF) system. The study will enroll up to 25 patients at up to six clinical sites in the United States, advised the company.

According to the company, the VENOS-2 study is being performed under an FDA investigational device exemption (IDE). The study will evaluate the feasibility of the Velocity system, which is designed to enable a minimally invasive approach for the creation of a pAVF for hemodialysis vascular access.

The first procedures in the study were performed by Rashid Sharaf, MD, an interventional nephrologist at the STAR Vascular Access Center in San Antonio, Texas.

“I am excited to participate in the VENOS-2 study and to evaluate the Velocity system as a next-generation alternative for the creation of pAVFs,” commented Dr. Sharaf in Venova’s press release. “pAVFs offer a minimally invasive alternative to surgical approaches and provide a potentially better option for shorter time to fistula creation and maturation, which can lessen the exposure to, and risks associated with, hemodialysis catheters.”

Erik van der Burg, CEO and Cofounder of Venova Medical, stated in the press release, “The launch of the VENOS-2 study is an important milestone in our mission to provide safer, more effective, and more durable vascular access solutions for the hemodialysis population.”

He continued, “The outcomes of the VENOS-2 study will build on our first-in-human experience with the Velocity system and will be used to support our United States pivotal study IDE. We are immensely grateful to Dr. Sharaf and his team for their support in enrolling the first [patients] of the VENOS-2 study.”