Xeltis’ restorative vascular access graft, aXess, has been successfully implanted in the first patient in Poland, as part of the aXess pivotal trial.
The Lower Silesia Center of Heart Diseases MEDINET in Wroclaw, where the procedure has taken place, is the first site in the country as part of this clinical study to start enrollment of patients with end-stage renal disease requiring hemodialysis.
“We are very pleased to be able to offer potentially longer lasting vascular access to patients that would not have fistula as an option. Unfortunately, we see many of them who are limited in their hemodialysis access options, due to their age and the health and strength of their vessels,”
said Dr Jakub Turek who conducted the procedure in Wroclaw.
“We hope this may open a new route to vascular access for many patients.”
The aXess pivotal trial is a prospective, single arm study to evaluate the safety and performance of aXess in patients with end-stage renal disease who need hemodialysis. The study will enroll 110 patients in up to 25 centers in Europe and will follow them for five years.
The aXess graft has been previously successfully implanted in 20 patients in Europe, as part of the aXess first-in-human (FIH) trial, which completed enrolment in September 2022. Highly encouraging six-month data from this trial have been presented by Professor Matteo Tozzi, University of Insubria, Italy at the congress of the Vascular Access Society in Porto, Portugal in April 2023.
For further information on the aXess Pivotal trial: www.axesspivotal.com
