Xeltis announced today the initiation of a pivotal trial with the “first-ever” restorative synthetic haemodialysis access grafts, dubbed ‘Axess’.
The first two patients have been successfully implanted as part of the AXESS European pivotal trial at AZ Sint-Jan Brugge-Oostende AV (Bruges, Belgium) by vascular surgeon Jan De Letter, and discharged from hospital.
The AXESS EU pivotal trial is a prospective, single-arm study to evaluate the safety and performance of Axess in patients with end-stage kidney disease who need haemodialysis. The study will enrol 110 patients at up to 25 centres in Europe and will follow them for five years.
The Axess graft has been previously successfully implanted in 20 patients, as part of the AXESS first-in-human (FIH) trial, which completed enrolment in September 2022. AXESS FIH full cohort data are expected in 2023.
“A device that enables immediate use, as seen with the existing synthetic ePTFE [expanded polytetrafluoroethylene] grafts, and turns into a living blood vessel that recovers promptly after puncturing from each dialysis session may become the safer and longer-lasting solution that patients on haemodialysis need,” explained De Letter, who also has previous experience with Axess, having implanted it during the FIH trial. “We are encouraged by the promising preliminary experience with this device from the FIH trial, and confirmation in a larger trial involving more patients and implanting sites is an important next step.”
The Axess graft is a restorative, synthetic, electrospun blood vessel for arteriovenous haemodialysis access. Once implanted, its porous microstructure gets colonised by the patient’s own tissue cells through the body’s natural healing process, turning into a living vessel made of their own tissue over time.
“Life for patients on haemodialysis means multiple hospital visits each week, involving puncturing, bleeding, waiting, healing and risk of infections from all of the above, in addition to poor renal function,” added An De Vriese, head of Nephrology and Infectious Diseases at AZ Sint-Jan Brugge-Oostende AV, and one of the coordinating investigators of the AXESS EU pivotal trial. “If a novel device can spare part of this burden through reduced bleeding, prompt coagulation and healing, lower infection risks and longer durability, it would be a life-changing experience for most patients.”