Xeltis Commences Pivotal Trial of aXess Hemodialysis Access Graft in Europe

November 10, 2022—Xeltis announced the initiation of the pivotal trial in Europe for the aXess hemodialysis access grafts.

According to the company, the aXess graft is a restorative, synthetic, electrospun blood vessel for arteriovenous hemodialysis access. After implantation, the device’s porous microstructure gets colonized by the patient’s own tissue cells through the body’s natural healing process. It turns into a living vessel made of patient’s own tissue over time. aXess is an investigational device and is not approved for sale.

The AXESS European 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 at up to 25 centers in Europe. The study patients will be followed for 5 years.

An De Vriese, MD, Head of Nephrology and Infectious Diseases at AZ Sint-Jan Brugge-Oostende AV, in Bruges, Belgium, is one of the coordinating investigators of the AXESS pivotal trial.

In the company’s press release, Dr. De Vriese commented, “Life for patients on hemodialysis 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. 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 first two patients in the AXESS European pivotal trial were enrolled by Vascular Surgeon Jan De Letter, MD, at AZ Sint-Jan Brugge-Oostende AV. The devices were successfully implanted, and the patients discharged from hospital, noted the company’s press release.

Dr. De Letter also has experience with implanting the aXess device during the AXESS first-in-human (FIH) trial, which completed enrollment in September 2022. In the FIH trial, 20 patients were successfully implanted with the aXess device. The full cohort data from the AXESS FIH trial are expected in 2023.

Dr. De Letter stated in the press release, “A device that enables immediate use, as seen with the existing synthetic 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 hemodialysis need. 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 company advised that the AXESS FIH trial is a prospective, single-arm, nonrandomized, multicenter FIH feasibility study to evaluate the preliminary safety and performance of the Xeltis hemodialysis access graft in adult patients with end-stage renal disease, who plan to undergo hemodialysis for at least 6 months and are deemed unsuitable for fistula creation. The trial is ongoing in six implanting centers in Europe, based in Belgium, Italy, Latvia, and Lithuania.