EINDHOVEN, The Netherlands, July 7, 2026
Xeltis has announced the first commercial implantation of its aXess™ vascular access device, officially launching the company’s European commercialization program for its next-generation hemodialysis technology. The milestone procedure was successfully performed by Dr. Dominik Liebetrau at Artemed Klinikum Munich South in Germany, bringing the innovative regenerative implant into routine clinical practice for the first time. Following CE mark approval supported by positive European pivotal trial results, aXess™ introduces a first-of-its-kind living vascular access solution designed to provide patients requiring long-term hemodialysis with durable and reliable vascular access. The commercial launch represents a major advancement in regenerative medical technology, expanding treatment options for patients with chronic kidney disease while supporting improved long-term clinical outcomes.
aXess Uses Regenerative Technology to Create a Living Blood Vessel
Unlike conventional vascular access grafts, aXess™ is built on Nobel Prize-winning supramolecular polymer technology that enables the implanted scaffold to gradually transform into the patient’s own living blood vessel through natural tissue regeneration. Immediately after implantation, the device functions as a scaffold suitable for cannulation, while over time it becomes integrated with the patient’s own tissue as the implant is progressively absorbed. This regenerative approach is intended to combine the early usability associated with synthetic grafts with the long-term biological advantages of a natural vessel. According to Dr. Dominik Liebetrau, the device integrated seamlessly into existing vascular surgery workflows, making clinical adoption straightforward while providing physicians with a fundamentally new option that may improve both treatment durability and patient quality of life.
Clinical Data Supports Commercial Expansion Across Europe
The European commercial rollout follows encouraging 12-month pivotal clinical trial data, demonstrating secondary patency rates comparable to mature arteriovenous fistulas (AVFs) while delivering lower reintervention rates and strong resistance to infection compared with historical arteriovenous graft (AVG) benchmarks. These results support the clinical value of the technology as a differentiated vascular access solution for patients undergoing long-term hemodialysis. Xeltis Chief Executive Officer Eliane Schutte stated that the first commercial implant represents the company’s transition from clinical development into routine patient care and establishes the foundation for broader commercialization throughout Europe before future expansion into the United States. Vice President of Commercial Elmar Horn added that the company’s immediate focus is to support participating hospitals, ensure successful adoption by physicians, and responsibly expand patient access across Germany and additional European markets.
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U.S. Pivotal Trial Progresses as Global Commercial Strategy Expands
Alongside the European launch, Xeltis continues advancing its U.S. pivotal clinical trial, which has now exceeded 50% patient enrollment, supporting the company’s long-term global commercialization strategy. Medical Advisory Board member Dr. Peter A. Schneider noted that aXess™ represents the first non-autologous vascular conduit specifically designed to become the patient’s own living vessel through vascular cell ingrowth and tissue regeneration, potentially addressing a significant unmet need in vascular access by combining rapid cannulation with the long-term benefits of biologically regenerated tissue. Built on the company’s proprietary Restorex® regenerative platform, aXess™ demonstrates the growing role of regenerative biomaterials in cardiovascular medicine and positions Xeltis to expand its technology into additional vascular and cardiovascular applications. The successful commercial introduction of aXess™ marks an important milestone in hemodialysis innovation, offering physicians and patients a novel regenerative alternative that could reshape the future of long-term vascular access.
Source: Xeltis press release
