Xeltis has announced the start of its pivotal clinical trial for aXess, a first-of-its-kind restorative synthetic hemodialysis access graft. The first two patients have been successfully implanted with the aXess graft at AZ Sint-Jan Brugge-Oostende AV in Bruges, Belgium, marking a significant step forward in vascular access for hemodialysis patients.
AXESS Pivotal Trial Details
The AXESS European pivotal trial is a prospective, single-arm study designed to evaluate the safety and performance of aXess in patients with end-stage renal disease (ESRD) requiring hemodialysis. The trial aims to enroll 110 patients across up to 25 centers in Europe, with a follow-up period of five years. This trial builds upon the foundation laid by the AXESS first-in-human (FIH) trial, which completed enrollment in September 2022 with 20 patients. Full cohort data from the FIH trial are expected in 2023.
How aXess Works
The aXess graft is a synthetic, electrospun blood vessel designed for arteriovenous hemodialysis access. Once implanted, its porous microstructure facilitates colonization by the patient's own tissue cells, transforming it into a living vessel composed of the patient's tissue over time. This restorative approach aims to overcome the limitations of current synthetic grafts, which often suffer from limited durability, bleeding after puncturing, infections, and clotting.
Addressing Unmet Needs in Hemodialysis
Patients with kidney disease needing hemodialysis often face long waits for fistula maturation, the creation of an enlarged vessel, which is the first-line treatment. When fistulas are not viable, synthetic access grafts are used, but these have limitations. The aXess graft offers a potential solution by enabling immediate use and evolving into a living blood vessel, potentially improving safety and longevity.
Dr. An De Vriese, Head of Nephrology and Infectious Diseases at AZ Sint-Jan Brugge-Oostende AV, a coordinating investigator for the AXESS EU pivotal trial, highlighted the potential impact on patients' lives: "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."
The Broader Context of ESRD
The number of end-stage kidney disease (ESKD) patients requiring hemodialysis is increasing worldwide, placing a substantial economic burden on healthcare systems. Current vascular access options have high complication rates. Arteriovenous fistulas (AVFs) are preferred, but their long maturation time and low success rate have led to a shift towards the 'right access' approach, increasing the demand for alternative solutions.
Potential Benefits of aXess
The aXess graft aims to combine the benefits of existing options, offering immediate cannulation, improved patency rates, reduced bleeding times after needle removal, and lower access site infection rates compared to commercially available AVGs. The primary endpoints of the AXESS EU pivotal trial include freedom from device-related serious adverse events and primary patency at six months.
Eliane Schutte, CEO of Xeltis, stated, "The initiation of the pivotal phase for the aXess graft confirms our capability to fast-track promising solutions to improve patients’ lives and our commitment to substantial evidence."
