Xeltis, a medtech company focused on regenerative implants, has announced the presentation of positive results from its aXess trials at the 46th Annual Charing Cross Symposium. The aXess conduit is designed for adult patients with end-stage renal disease requiring vascular access for hemodialysis and deemed unsuitable for fistula creation.
The aXess conduit is a restorative arteriovenous dialysis graft that facilitates the creation of a new, long-term living vessel. It aims to combine the safety and patency of an arteriovenous fistula (AVF) with the speed to treatment of an arteriovenous graft (AVG). This approach seeks to improve the dialysis patient experience and reduce complications such as infections and the need for frequent reinterventions, which are common challenges in renal disease patients.
Key Presentations at Charing Cross Symposium
Dr. Robert Shahverdyan, Head of Vascular Access Center Hamburg, Germany, presented the latest results from the aXess trials. These multicenter, European single-arm studies evaluated the safety and performance of the aXess graft in patients over 18 years old with end-stage renal disease who were not suitable candidates for fistula creation. The presentation highlighted advancements in hemodialysis access using the aXess graft.
Prof. Dr. Frans Moll from the Department of Vascular Surgery at the University Medical Center in Utrecht, The Netherlands, discussed the potential of supramolecular polymer technology in reducing infections in vascular conduits. His presentation focused on how Xeltis' transformative conduits could significantly lower infection rates in various clinical applications.
How aXess Works
The aXess conduit utilizes Xeltis' proprietary endogenous tissue restoration (ETR) platform. This platform employs an advanced polymer implant that regenerates the patient's own tissue. Over time, the polymer is gradually absorbed, leaving behind a new, living, and long-lasting vessel. This approach has the potential to overcome the limitations of current hemodialysis access options.
Clinical Development and Future Directions
A first-in-human trial of aXess demonstrated a significant improvement in performance compared to existing hemodialysis vascular access solutions. Currently, a pivotal trial is enrolling up to 110 patients across nine EU countries to further evaluate the safety and efficacy of the aXess conduit. The trial aims to confirm the initial findings and establish aXess as a viable alternative for hemodialysis vascular access.
Xeltis believes that its technology has the potential to be applied to other major vascular and cardiovascular diseases, addressing the limitations of currently available options for millions of people requiring hemodialysis access grafts or cardiovascular replacements each year.
