Xeltis announced today the completion of participant enrollment in its EU pivotal trial for aXess, a pioneering vascular access conduit. The trial is focused on evaluating the conduit in adults suffering from end-stage renal disease. Based in Eindhoven, The Netherlands, Xeltis is leading the study involving 120 participants across 22 European locations. This initiative comes after promising 12-month data from an initial EU trial showcasing a boost in performance over existing hemodialysis vascular access solutions and a reported 0% infection rate.
aXess facilitates the development of a novel, permanent, living vessel designed for hemodialysis vascular access. The technology combines the safety and longevity of arteriovenous fistula (AVF) with the quick accessibility of arteriovenous grafts (AVG). It is engineered to enhance dialysis patient experience by preventing reinterventions and complications such as infections.
Designed to be replaced by the patient’s healthy tissue over time, Xeltis’ implant platform has been utilized in treating over 100 patients across various trials. Parallelly, the company is also enrolling up to 140 patients in a crucial U.S. trial.
“Completing enrollment is a vital step towards elevating the standard of care for patients with end-stage renal disease,” said Paulo Neves, Xeltis’ chief medical officer. He looks forward to the project’s advancements towards CE approval, extending gratitude to trial participants and study teams.
### New Leadership at Xeltis
In a parallel announcement, Xeltis appointed Rob Eyers as its new Chief Technology Officer. With over 30 years of experience in cardiovascular medtech, Eyers brings valuable expertise from his previous role at Veryan Medical. His background also includes positions at CR Bard (now Medtronic), Merit Medical, Proxy Biomedical, and Boston Scientific.
“Xeltis’ groundbreaking endogenous tissue restoration (ETR) technology represents a significant leap in medical device innovation,” Eyers commented. “Built to regenerate patient tissue while minimizing reinterventions and infections associated with current treatments, this technology holds the potential to significantly improve patient outcomes. Xeltis is moving swiftly towards market introduction and achieving exceptional clinical results, and I am thrilled to be part of this dynamic team, further propelling regulatory approvals and aiding in platform development.”