Xeltis announced on July 14 the start of European commercialization for its aXess vascular access device, following the successful treatment of the first commercial patient by Dr. Dominik Liebetrau at Artemed Klinikum Munich South in Germany.
aXess is described as a new category of vascular access, implanted in a single procedure and based on supramolecular science. The device initially acts as a scaffold for cannulation and gradually transforms into each patient’s own living vessel, aiming to provide long-term and reliable vascular access for hemodialysis patients.
The commercial launch comes after positive 12-month European pivotal data showed secondary patency comparable to matured arteriovenous fistulas, lower reintervention rates, and high infection resistance compared with historical arteriovenous graft benchmarks. Xeltis said this marks the beginning of its broader rollout across Europe.
Dr. Dominik Liebetrau 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 hemodialysis access and has the potential to improve treatment outcomes and quality of life.”
Eliane Schutte, Chief Executive Officer at Xeltis, said, “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 U.S.”
Peter A. Schneider, Member of the Medical Advisory Board at 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 efforts, Xeltis continues enrollment in its United States pivotal trial of aXess, which now exceeds 50 percent enrollment.
