Xeltis today announced what it describes as “very promising” preliminary efficacy and safety results from one of the centres participating in the AXESS study—a first-in-human (FIH) clinical trial of its restorative haemodialysis access graft, Axess.
The company has also reported that enrolment in the trial is now complete, with 20 patients having been successfully implanted with the Axess graft.
During haemodialysis, the Axess device demonstrated 100% cumulative primary and secondary patency, with an average follow-up time of 5.8 months and no device-related complications, in patients implanted by Matteo Tozzi and his team at the University of Insubria (Varese, Italy)—one of six European sites participating in the trial.
These data will be presented at the Porto Vascular Conference (PVC; 7–8 October 2022, Porto, Portugal), organised by the European Society of Vascular Surgery (ESVS). To date, Axess has enabled more than 1,200 haemodialysis sessions in just over a year as part of the AXESS FIH trial. Sixty of these sessions have taken place in Varese, a Xeltis press release states.
“Our initial clinical experience with Axess is very promising, from implanting to puncturing, and the data on functionality observed so far are very encouraging,” Tozzi commented.
Xeltis’ Axess device is a synthetic, bio-restorative vessel graft that enables early puncturing needed to connect to the haemodialysis machine. Unlike any currently available options—according to Xeltis—it is also designed to turn into a patient’s own living blood vessel, like an arteriovenous fistula, as its porous structure gets gradually colonised by patient’s own tissue cells.
According to the experience in Varese, Axess improved compliance over time, which may result from new tissue forming in the device.