Venova Medical's multi-center, prospective VENOS-2 early feasibility study intended to provide proof of concept and initial clinical safety data for the Velocity pAVF System has completed enrollment. This study is being conducted in the U.S. under an Investigational Device Exemption (IDE) granted by the FDA. The Velocity System is designed to enable a minimally invasive approach for the creation of an AV fistula for hemodialysis vascular access.
LOS GATOS, Calif., April 17, 2025 /PRNewswire-PRWeb/ -- Venova Medical, a privately held company developing a next generation technology for the creation of percutaneous arteriovenous fistulas (pAVF) for hemodialysis access, today announced the successful completion of patient enrollment for the company's VENOS-2 early feasibility study (NCT06712251). This multi-center study is being performed under an Investigational Device Exemption (IDE) granted by the FDA and is providing proof of concept and initial clinical safety data for the Velocity pAVF System. The Velocity System is designed to enable a minimally invasive approach for the creation of an AV fistula for hemodialysis vascular access.
"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 Rishi Razdan, MD, Medical Director of Azura Vascular Care Jacksonville, a vascular and interventional radiologist specializing in dialysis access management and an investigator for the VENOS-2 study. "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."
"We are thrilled to complete enrollment of this early feasibility study of the Velocity System and are tremendously grateful for the study investigators, their staff, and all of the individuals who agreed to participate in this trial," stated Erik van der Burg, CEO and Co-founder of Venova Medical. "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 U.S. pivotal trial which will enable us to pursue U.S. approval for the device".
About Venova Medical
Venova Medical, Inc. is a privately held company addressing the challenges associated with providing optimal vascular access for patients needing hemodialysis. The company has developed the Velocity System, a next generation percutaneous AVF technology designed to reduce the need for reinterventions to achieve fistula maturation and improve vascular access outcomes while reducing costs. The company is currently conducting the prospective, multi-center, single-arm VENOS-2 IDE clinical study (NCT06712251) which is evaluating the safety and feasibility of Velocity System in patients on hemodialysis who are candidates for arteriovenous fistulas.
For more information, visit www.venovamedical.com
Media Contact
Erik van der Burg, Venova Medical, 1 408.242.5897, [email protected], www.venovamedical.com
SOURCE Venova Medical
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