One-Year Outcomes of the VENOS-1 Trial: A Novel Percutaneous Arteriovenous Fistula for Hemodialysis Access

Sunday, March 30, 2025

3:54 PM – 4:03 PM CT

Location: Music City Center, 202 BC

Presenting Author(s)

Shant Vartanian, MD

Associate Clinical Professor - Volunteer
University of California, San Francisco, United States

Author/Co-author(s)

RS

Robert Shahverdyan, MD

Physician
Asklepios Clinic Barmbek, Germany
DH

Dirk Hentschel, MD

Director of Interventional Nephrology
Brigham and Women's Hospital, United States
AE

Adrian Ebner, MD

Director of Interventional Cardiology
Italian Hospital Asuncion, Paraguay, United States
EV

Erik Van Der Burg, MS

Co-Founder, CEO
Venova Medical, United States

Purpose: Achieving quality starts in dialysis depends on reliable AVF maturation. While percutaneous arteriovenous fistulas (pAVF) offer a solution to access creation barriers, current devices often result in lost flow into the deep venous system requiring secondary procedures. This first-in-human study assessed the technical feasibility and safety of a novel implant-based pAVF designed to replicate surgical AVF anatomy, optimizing flow for rapid maturation and cannulation.

Materials and Methods: The VENOS-1 trial (NCT 05757726) is a prospective, single-arm, open-label early feasibility study. The primary effectiveness endpoint was procedural success, with safety measured by serious adverse device events and major reinterventions at 6 weeks. Secondary endpoints included physiologic maturation (brachial artery flow >500 ml/min and venous outflow >5 mm), reintervention rate, and functional maturation.

Results:

Ten ESRD patients were enrolled with 12-month follow-up. Mean age was 45.1 years (27-61) and the average BMI was 24.3 kg/m² (SD ± 9.2). Procedural success was 100%, with no serious adverse events or major reinterventions at 6 weeks. At 6 weeks, mean brachial artery flow was 972 ml/min (SD ± 229), and cephalic vein diameter increased to 6.3 mm (SD ± 1.0 mm). Physiologic maturation was achieved in all patients without reintervention, on average by day 18 (range 13-40). Two-needle inline cannulation was successful in 90% of subjects. Only two reinterventions were needed across 10 subjects, for a rate of 0.2 reinterventions per patient per year. Primary patency at 1 year was 80%.

Conclusion:

Long-term results show the novel pAVF is highly effective in creating, maturing, and supporting early use of a proximal forearm AVF. Its optimized flow promotes rapid maturation without the need for flow-diverting procedures. These findings suggest the device could lead to more optimal dialysis starts and support further study in larger populations.