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July 15, 2026

Xeltis aXess Vascular Access Device for Hemodialysis Launched in Europe

KEY TAKEAWAYS

  • Xeltis initiates European commercialization of the aXess vascular access device with the first commercial patient treated in Germany.
  • 12-month European pivotal trial data show secondary patency comparable to matured AVFs, with lower reintervention rates and high infection resistance compared with historical AVGs benchmarks.
  • The device initially serves as a scaffold ready for cannulation before transforming into each patient’s own living vessel.

July 15, 2026—Xeltis announced the official start of the European commercialization of aXess vascular access device for patients requiring hemodialysis. The first commercial patient was treated by Dominik Liebetrau, MD, Head of Vascular Surgery at Artemed Klinikum Munich South in Munich, Germany.

The aXess vascular access device, which is implanted in a single procedure, initially serves as a scaffold ready for cannulation before gradually transforming into each patient’s own living vessel, for long-term, reliable vascular access.

According to the company, the commercial launch comes after positive 12-month data from the European pivotal trial demonstrating secondary patency comparable to matured arteriovenous fistulas, alongside lower reintervention rates and high infection resistance compared with historical arteriovenous graft benchmarks. Additionally, Xeltis continues enrollment in its United States pivotal trial of aXess, which now exceeds 50% enrollment.

“aXess integrated seamlessly into our existing surgical workflow, making adoption straightforward for our team,” commented Dr. Liebetrau in the Xeltis press release. “It offers a fundamentally new approach to vascular access—providing an implant that is designed to transform into the patient’s own living vessel. This provides physicians with a valuable new option for patients requiring long-term hemodialysis access and has the potential to improve treatment outcomes and quality of life.”

Peter A. Schneider, MD, a member of the Xeltis Medical Advisory Board, added, “This is the first time we have access to a nonautologous conduit designed to become the patient’s own vessel over time through vascular cell in-growth and tissue regeneration, ultimately behaving more like an autologous vessel. This approach has the potential to address a significant unmet need in vascular access by combining fast availability for cannulation with the long-term benefits of a living vessel.”

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