Xeltis’ FIH Study of aXess Vascular Graft for Hemodialysis Is Presented

May 5, 2023—Xeltis recently announced the presentation of 6-month data from its first-in-human (FIH) trial of the company’s aXess vascular graft for patients with chronic kidney disease requiring hemodialysis.

The aXess-FIH data were presented by Professor Matteo Tozzi, MD, Principal Investigator of the study, at the 13th Congress of the Vascular Access Society in Porto, Portugal. Tozzi is Professor of Vascular Surgery, the University of Insubria in Varese, Italy.

Xeltis stated that the single-arm, nonrandomized aXess FIH feasibility study, which is being conducted in Europe, is evaluating the preliminary safety and performance of the aXess graft in patients aged > 18 years with end-stage renal disease and deemed unsuitable for fistula creation. Follow-up visits were conducted at regular intervals after the initial procedure, with full study follow-up visits to be conducted at 5 years.

According to the company, the aXess graft demonstrated high patency rates (80% primary patency, 95% primary assisted patency, 100% secondary patency) at 6 months. Additionally, there was a 0% infection rate and low reintervention rates, resulting in a highly favorable safety profile.

Hemodialysis was successfully performed through the graft, and compared to the current standard of care measures, which typically show lower rates of patency combined with a greater risk of infection or rejection, aXess demonstrated extremely promising results, reported Xeltis in the press release.

Prof. Tozzi commented in the company’s press release, “These 6-month data are very promising in terms of patency and infection rates and suggest that aXess has great potential to be a game-changing alternative to existing vascular access options, which have a number of significant shortcomings. Xeltis’ vascular access implants, which harness the power of the body’s natural healing processes, could play a vital part in significantly improving the lives of patients requiring hemodialysis.”

The company further noted that the aXess pivotal trial is currently enrolling up to 110 patients across up to 25 sites in nine European Union countries.