Xeltis has presented “highly-encouraging” six-month data from its first-in-human (FIH) aXess vascular graft trial at the 13th Congress of the Vascular Access Society (VAS; 27–29 April, Porto, Portugal).
A press release outlines that six-month data from the FIH trial found that the aXess vascular access graft for haemodialysis demonstrated high patency rates (80% primary patency, 95% primary assisted patency, 100% secondary patency). At six months, a 0% infection rate and low re-intervention rates were reported, resulting in a highly favourable safety profile. Haemodialysis was successfully performed through the graft, and compared to 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.
The full data will be presented by Matteo Tozzi (University of Insubria, Varese, Italy) in a presentation entitled “aXess Vascular Graft—FIH trial 6-month outcomes” at the VAS conference.
Tozzi, who is principal investigator in Xeltis’ FIH clinical trial, said: “These six-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 haemodialysis.”
The aXess FIH trial is a single-arm, non-randomized FIH feasibility study in Europe evaluating the preliminary safety and performance of the aXess graft in subjects who are older than 18 years with end-stage renal disease, and who are deemed unsuitable for fistula creation. Follow-up visits were conducted at regular intervals after initial procedure, with full study follow-up visits to be conducted at five years. The aXess pivotal trial is currently enrolling up to 110 patients across up to 25 sites in nine EU countries.
