Xeltis aXess™ EU Clinical Data

Xeltis announced groundbreaking 12-month clinical data from its aXess™ multi-center EU pivotal trial, demonstrating the transformative potential of the implant in hemodialysis treatment. The study, involving 120 patients across 22 sites in 9 European countries, showed strong durability with 79% secondary patency at 12 months, a low reintervention rate of 1.3 per patient year, and a 3% access-related infection rate. These results are significantly better than conventional arteriovenous grafts (AVG) and central venous catheters (CVC). The findings build on earlier six-month data and long-term clinical cases exceeding four years, reinforcing the technology's clinical benefit and durability. Following these results, Xeltis obtained CE mark approval, enabling the commercialization of aXess™ in Europe. Eliane Schutte, CEO of Xeltis, highlighted the safety, ease of implantation, and tissue-like transformation of aXess™, emphasizing its potential to improve patient outcomes and save lives. Key opinion leaders like Augusto Minzolini, An De Vriese, and Peter Schneider also praised the technology for its reduced intervention burden, infection resistance, and the achievement of endothelium along the lumen. The aXess™ implant leverages Restorex™ polymer technology, which regenerates the patient's own tissue, forming living and long-lasting vessels. Xeltis presented these data at The 48th Charing Cross Symposium in London.