Xeltis aXess Hemodialysis Vascular Conduit FIH Trial Presented With 12-Month Data

November 17, 2023—Xeltis announced 12-month data from the first-in-human (FIH) trial of the company’s aXess vascular conduit, a hemodialysis access graft. The aXess restorative conduit is designed to enable the creation of a new long-term living vessel for hemodialysis vascular access.

In the aXess-FIH trial, the device demonstrated 100% secondary patency, 78% primary assisted patency, and 0% infections in 20 patients implanted with the aXess conduit. These results represent a significant improvement over current standard of care, the company stated.

The data were presented by Professor Frans Moll, MD, at the 50th annual VEITHsymposium held November 14-18 in New York, New York, in a presentation entitled, “Novel Application of Polymer Technology to Create Endogenous Tissue With Host Collagen and Endothelium Compatible With Flowing Blood: 1-Year Clinical Results of the aXess Graft.” Prof. Moll, who serves as a member of the Xeltis Medical Advisory Board, is a vascular surgeon with the Department of Vascular Surgery, University Medical Center in Utrecht, The Netherlands.

According to Xeltis, these findings build on the 6-month data presented in April 2023 at the 13th Congress of the Vascular Access Society in Porto, Portugal. To date, more than 3,500 dialysis sessions have been conducted across six centers in Belgium, Italy, Latvia, and Lithuania.

The aXess FIH trial is a single-arm feasibility study conducted in Europe to evaluate the preliminary safety and performance of the aXess graft in patients aged > 18 years with end-stage renal disease who are deemed unsuitable for fistula creation. Follow-up visits were conducted at regular intervals after the initial procedure, with study follow-up visits to be conducted for 5 years.

A separate pivotal trial of aXess is underway, enrolling up to 110 patients across up to 25 sites in nine European Union countries, with > 40 patients already implanted, advised the company.

“The 12-month data from the aXess FIH trial are highly encouraging and continue to demonstrate the potential of the aXess vascular conduit to combine the early benefits of arteriovenous graft, such as early cannulation and no maturation needed, with the long-term advantages of arteriovenous fistula, including better patency rates, a reduced need for intervention, and low infection rates,” commented Prof. Moll in the company’s press release.