Xeltis has reported encouraging early efficacy and safety outcomes from one of the centers involved in the AXESS study, a first-in-human clinical trial evaluating its Axess restorative hemodialysis access graft. The company also announced the completion of enrollment in the trial, with a total of 20 patients having received the Axess graft.
Early Patency and Functionality
Data from the University of Insubria (Varese, Italy), one of the six European sites participating in the trial, showed that the Axess device achieved 100% cumulative primary and secondary patency during hemodialysis, with an average follow-up duration of 5.8 months. No device-related complications were observed in these patients, according to Xeltis.
Matteo Tozzi from the University of Insubria commented, "Our initial clinical experience with Axess is very promising, from implanting to puncturing, and the data on functionality observed so far are very encouraging."
Novel Bio-Restorative Design
The Axess device is a synthetic, bio-restorative vessel graft engineered to facilitate early puncturing for connection to hemodialysis machines. Xeltis states that, unlike existing options, Axess is designed to convert into a patient's own living blood vessel, similar to an arteriovenous fistula. Its porous structure allows gradual colonization by the patient's own tissue cells.
According to the experience in Varese, the Axess graft exhibited improved compliance over time, potentially due to the formation of new tissue within the device. As part of the AXESS FIH trial, Axess has enabled more than 1,200 hemodialysis sessions in just over a year. Sixty of these sessions have taken place in Varese.
