Venova Medical Announces First Subjects Enrolled in VENOS-3 Pivotal IDE Study of the Velocity® Percutaneous AVF System
Venova Medical, a privately held company developing next-generation technology for the creation of percutaneous arteriovenous fistulas (pAVF) for hemodialysis access, announced today the enrollment of the first subjects in the company’s VENOS-3 pivotal study (NCT07153939) of the Velocity pAVF System. The VENOS-3 study, performed under an Investigational Device Exemption (IDE) granted by the FDA, is a prospective, multi-center, single-arm clinical trial designed to enroll up to 126 patients with advanced or end-stage kidney disease at up to 40 sites across the U.S. The study is being conducted to further establish evidence of the safety and efficacy of the Velocity System to create a percutaneous arteriovenous (AV) fistula for hemodialysis access.