Venova Medical, a privately held company developing a next-generation technology for the creation of percutaneous arteriovenous fistulas (pAVF) for hemodialysis access, today announced approval from the US Food and Drug Administration (FDA) to initiate its Multicenter Pivotal Study of the Velocity™ Percutaneous Arterio-Venous Fistula System (VENOS-3). The IDE approval enables the Company to commence the VENOS-3 study to gather further evidence of the safety and effectiveness of the Velocity System to create an arterio-venous (AV) fistula for hemodialysis access in patients with advanced or end-stage kidney disease.
Shant Vartanian, MD, is the UCSF inventor. We congratulate his success.