Enrolment in the AXESS first-in-human (FIH) trial of Xeltis’ restorative hemodialysis vascular access graft, aXess, has been completed, with 20 patients successfully implanted. Very promising preliminary efficacy and safety results from one of the participating centers will be presented at the Porto Vascular Congress (PVC) organized by the European Society of Vascular Surgery (ESVS) on October 7 and 8.
During hemodialysis, the aXess device demonstrated 100 percent cumulative primary and secondary patency, with an average follow-up time of 5.8 months and no device-related complications in patients implanted by Professor Matteo Tozzi and his team at University of Insubria in Varese (Italy), one of the six European sites participating in the trial. The data will be presented at PVC on Saturday 8 October. To date, aXess has enabled more than 1200 hemodialysis sessions in just over a year as part of the AXESS FIH trial, of which 60 sessions in Varese.
“Our initial clinical experience with aXess is very promising, from implanting to puncturing, and the data on functionality observed so far are very encouraging,” Professor Tozzi commented.
“An access graft able to combine the benefits of immediate hemodialysis start – typical of 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,” said Professor Mauro Gargiulo, President of the ESVS at PVC, who will be leading the next phase of aXess’ clinical investigations. “Particularly for patients who are unsuitable for fistula creation, a longer lasting alternative option to ePTFE grafts is certainly an option worth exploring.”
“These exciting early outcomes from the AXESS study confirm the overall very positive progression in clinical trials of our whole restorative cardiovascular technology platform, including coronary artery bypass grafts and heart valves,” said Eliane Schutte, Xeltis CEO.
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