aXess, Xeltis’ restorative vascular access graft for hemodialysis, has been successfully implanted in the first patient in Greece, as part of the aXess pivotal trial. The procedure took place at the University Hospital of Patras, which recently started enrolling patients, along with several other sites in Europe.
“A hybrid access device that starts like a normal ePTFE graft and turns into a living vessel may help improve access for patients that need hemodialysis but whose vessels aren’t suitable for fistulas,” explained Prof. Nikolaos Karydis, the vascular surgeon and sub-investigator who implanted the patient in Patras. “The trial will contribute to grow the body of evidence on its safety and durability which are the properties clinicians are after in vascular access”, said Prof. Stavros Kakkos, the Principal Investigator at University Hospital of Patras.
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 Prof. Matteo Tozzi, University of Insubria, Italy at the congress of the Vascular Access Society in Porto, Portugal in April.
For further information on the aXess Pivotal trial: www.axesspivotal.com