Xeltis has announced the official start of the European commercialisation of aXess, marked by the successful treatment of the first commercial patient by Dominik Liebetrau at Artemed Klinikum Munich South (Munich, Germany).
aXess is a restorative vascular access conduit for haemodialysis treatment. Implanted in a single procedure, the device initially serves as a scaffold ready for cannulation before gradually transforming into each patient’s own living vessel, for long-term, reliable vascular access, Xeltis states.
The commercial launch follows positive 12-month European pivotal data demonstrating secondary patency comparable to matured arteriovenous fistulas (AVFs), alongside lower reintervention rates and high infection resistance compared with historical arteriovenous graft (AVG) benchmarks. It marks the beginning of Xeltis’ broader European rollout of aXess, providing more physicians and patients with a differentiated vascular access solution that has the potential to transform the haemodialysis treatment landscape, the company adds.
Liebetrau, who is the head of vascular surgery at Artemed Klinikum Munich South, said: “aXess integrated seamlessly into our existing surgical workflow, making adoption straightforward for our team. 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 haemodialysis access and has the potential to improve treatment outcomes and quality of life.”
Eliane Schutte, CEO, Xeltis, added: “The first commercial implantation of aXess marks the transition from clinical development into routine patient care. It is an important milestone for Xeltis and the beginning of our European commercial launch, bringing a new treatment option to patients and physicians, while building the foundation for broader adoption across Europe and, ultimately, the USA.”
Elmar Horn, vice president of commercial, Xeltis, said: “Our first commercial implant is a significant milestone for Xeltis and reflects the commitment of our team and our physician partners. Our focus now is on supporting participating centres as they adopt aXess, delivering a positive experience for patients and physicians, and responsibly expanding patient access across Germany and Europe.”
Peter A Schneider, member of the medical advisory board, Xeltis commented: “This is the first time we have access to a non-autologous 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.”
Alongside European commercialization, Xeltis continues enrolment in its US pivotal trial of aXess, now exceeding 50% enrolment. The study builds on the positive European pivotal data and supports the company’s broader global commercialisation strategy.
