Xeltis aXess Restorative Hemodialysis Access Graft to be Evaluated in AXESS FIH Study in Europe

October 14, 2022—Xeltis recently announced completion of enrollment in the AXESS first-in-human (FIH) clinical trial of the company’s aXess restorative hemodialysis cardiovascular access graft. The prospective, single-arm, nonrandomized feasibility trial is composed of 20 patients enrolled at six centers in Europe, based in Belgium, Italy, Latvia, and Lithuania.

The AXESS trial will evaluate the preliminary safety and performance of the Xeltis hemodialysis access graft in adult patients with end-stage renal disease who plan to undergo hemodialysis for at least 6 months and are deemed unsuitable for fistula creation.

According to the company, the synthetic device is designed to turn into a patient’s own living blood vessel, like an arteriovenous fistula, as its porous structure is gradually colonized by the patient’s own tissue cells.

The company also noted that preliminary efficacy and safety results from one of the centers participating in the AXESS FIH trial were presented at the Porto Vascular Congress, organized by the European Society of Vascular Surgery and held October 7-8, 2022, in Porto, Portugal.

Professor Matteo Tozzi, MD, and colleagues conducted these implantation procedures at the University of Insubria in Varese, Italy. The findings included 100% cumulative primary and secondary patency, with an average follow-up time of 5.8 months and no device-related complications. The experience in Varese showed that aXess improved compliance over time, which may result from new tissue forming in the device, stated the company.

“Our initial clinical experience with aXess is very promising, from implanting to puncturing, and the data on functionality observed so far very encouraging,” commented Prof. Tozzi in the company’s press release.

Professor Mauro Gargiulo, MD, who will be leading the next phase of clinical investigations for the aXess device, added, “An access graft able to combine the benefits of immediate hemodialysis start—typical of expanded polytetrafluoroethylene (ePTFE) grafts—with a longer durability and reduced complications normally enabled by a fistula, may potentially change the treatment paradigm for vascular access in hemodialysis. Particularly for patients who are unsuitable for fistula creation, a longer-lasting alternative option to ePTFE grafts is certainly an option worth exploring.”