Xeltis’ Axess Restorative Hemodialysis Access Graft Evaluated in Early Data From FIH Trial

April 27, 2022—Xeltis announced preliminary results from a clinical trial of the company’s Axess restorative hemodialysis access graft. Axess is a synthetic biocompatible blood vessel that over time turns into a living vessel made of the patient’s own tissue—endogenous tissue restoration (ETR).

According to the company, the ongoing Axess first-in-human trial of the Axess device showed promising early puncturing, patency, and safety data. The findings were presented by trial investigator Professor Matteo Tozzi, MD, at the Charing Cross International Symposium 2022 held April 26-28 in London, United Kingdom.

The company advised that the Axess graft has been implanted in 11 patients with a median follow-up of 6.5 months. Overall, more than 600 dialysis sessions have been enabled in this patient group, with puncturing—or dialysis initiation—starting as early as 2 weeks after implantation in some patients.

In primary endpoints, the preliminary data analysis showed 100% functional patency and safety, no aneurysms or infections reported, and excellent ease of use for surgeons and dialysis nurses.

The company stated that the Axess graft enables early puncturing, working like some of the currently available expanded polytetrafluoroethylene synthetic hemodialysis access grafts; however, it is also designed to turn into a patient’s own living blood vessel, like an arteriovenous fistula.

Xeltis explained that in the ETR process, after implantation, the device’s biocompatible porous microstructure gets naturally colonized by the patient’s own tissue, which over time takes over functionality before the original device absorbs in the body.

Prof. Tozzi, who is with the University of Insubria in Varese, Italy, commented in the company’s press release, “Our first clinical experience using the Axess device is extremely encouraging. This fully synthetic graft is easy to implant, can be promptly punctured, and exhibits an excellent safety profile. Its potential to turn into a longer-lasting natural vessel is an additional benefit and suggests that an optimal solution for dialysis patients may be within our reach.”

Professor Frans Moll, MD, with University Medical Center in Utrecht, The Netherlands, who will present data on Axess preclinical developments at the Charing Cross meeting, added, “At a time when fistula is being challenged as a first-line treatment in a number of dialysis patients, the first-ever clinical data for Axess are particularly significant and aligned with its remarkable and unprecedented positive results from preclinical trials, showing its full endothelialization.”