Xeltis has announced that it has exceeded 50% enrolment in its US pivotal trial for aXess, its restorative vascular access conduit for haemodialysis treatment.
The US pivotal trial is a prospective, multicentre study evaluating the patency, safety, and performance of aXess in adult patients with end-stage renal disease (ESRD) requiring vascular access for haemodialysis.
To date, over 50% of the target patient enrolment has been achieved across 20 sites in the USA, marking a significant milestone towards the planned enrolment of 140 patients in total. The study is supported by US Food and Drug Administration (FDA) breakthrough device designation, which was granted in November 2024.
“Reaching this milestone reflects the strong momentum behind the aXess programme as we advance towards FDA approval in the USA,” Shawn Gage, vice president of US clinical affairs, Xeltis, said. “We are proud to witness true dedication, engagement, and excitement of our teams, investigators, and clinical partners. This achievement would not have been possible without the trust and commitment of the patients participating in the study, and we extend our sincere thanks to them and to the clinical sites for their continued support in executing this trial with excellence.”
“This study represents an important step in demonstrating the potential of aXess to improve outcomes for patients with ESRD requiring haemodialysis access,” said John Lucas III (Lucas Surgical Group, Greenwood, USA), the trial’s national principal investigator. “aXess is a unique technology, and it is encouraging to see the continued progress of the study as we work to validate its promise in transforming the haemodialysis landscape. We are deeply grateful to the patients whose participation makes this important work possible.”
This US study builds on recently presented positive 12-month data from the EU pivotal trial, which demonstrated higher secondary patency of aXess compared with historical benchmark of conventional arteriovenous grafts (AVGs) and comparable to matured fistulas, alongside lower reintervention rates, and enhanced resistance to infection. These data supported CE mark approval, enabling commercialisation in Europe.
