Xeltis aXess EU Pivotal Trial Completes Enrollment

January 7, 2025—Xeltis announced the completion of enrollment in its European Union (EU) pivotal trial for the aXess restorative vascular access conduit in adults with end-stage renal disease (ESRD). The trial enrolled 120 patients at 22 centers in nine countries across Europe.

According to Xeltis, the aXess EU pivotal trial is a prospective study investigating the patency, safety, and performance of the aXess device in adult patients with ESRD requiring vascular access to start or maintain hemodialysis therapy. The primary endpoint data is anticipated in Q2 2025, and the first market approval is expected in 2026.

“I am very proud to be contributing to this EU pivotal trial, which is a vital step toward demonstrating the potential of aXess to transform patient outcomes for those with ESRD,” commented Professor Loreto Gesualdo, MD, in the company’s press release.

Prof. Gesualdo, the trial’s Principal Investigator with Policlinico di Bari in Bari, Italy, continued, “Xeltis’ technology allows for the natural creation of living and long-lasting vessels, effectively addressing the issue of fistula nonmaturation without the risk of reverting to catheter use. This results in an improved dialysis patient experience, a clear unmet medical need. We extend our thanks to the patients involved, who made it possible to advance this study.”

The company noted that the aXess EU pivotal trial comes after the 12-month data from the first-in-human (FIH) EU trial, which demonstrated a significant improvement in performance compared to current hemodialysis vascular access solutions and a 0% infection rate. The aXess FIH trial data were presented by Professor Frans Moll, MD, at the 50th annual VEITHsymposium in November 2023.

Xeltis advised it is also currently enrolling up to 140 patients in the aXess US pivotal trial, with John Lucas III, MD, from Lucas Surgical Group in Greenwood, Mississippi, serving as the national Principal Investigator.

Additionally, Xeltis announced it has appointed Rob Eyers as Chief Technology Officer (CTO). The company stated that Eyers brings over 3 decades of experience in the cardiovascular medtech industry, in both corporate and startup environments. He joined Xeltis from Veryan Medical where he served as CTO. Previously, he worked for CR Bard (now Medtronic), Merit Medical, Proxy Biomedical, and Boston Scientific.