Preliminary results from a clinical trial of Xeltis’ restorative hemodialysis access graft, aXess, showed very promising early puncturing, functional patency and safety data. The data, from the ongoing first-in-human aXess trial, will be presented at CX 2022, the Charing Cross International Symposium on Vascular and Endovascular Challenges, in London for the first time today.
To date, 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 two weeks after implant in some patients. Preliminary data analysis shows very promising outcomes on primary endpoints. The current data show 100 percent functional patency and safety, with no aneurysms or infections reported, and excellent ease of use for surgeons and dialysis nurses.
“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,” explained Professor Matteo Tozzi, University of Insubria, Varese (Italy), the aXess trial investigator who presented the data at CX 2022. “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.”
View the full press release here