“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
