Xeltis Receives EU CE Mark for Bioabsorbable Hemodialysis Graft Following Successful 120-Patient Trial
Key Insights
Xeltis (search) has secured European CE mark approval for aXess (search), a bioabsorbable vascular access graft for hemodialysis patients based on positive 12-month pivotal trial data.
The 120-patient study demonstrated 79% secondary patency and significantly lower reintervention rates compared to conventional arteriovenous grafts and fistulas.
The bioabsorbable graft showed superior infection control with only 3% access-related infection rate versus 22% for central venous catheters and 9% for arteriovenous grafts.
Xeltis (search) has received European CE mark approval for aXess (search), a bioabsorbable vascular access graft for hemodialysis, following positive results from a 120-patient pivotal trial that demonstrated superior patency rates and reduced infection burden compared to conventional arteriovenous grafts.
Clinical Trial Results Demonstrate Superior Performance
The pivotal study enrolled a real-world patient population where 69% had previously used a central venous catheter and experienced failed fistula. The 12-month data showed aXess (search) achieved 79% secondary patency with a patency-related reintervention rate of 1.3 per patient year, alongside what the company described as a significant reduction in infection burden.
Comparative analysis revealed that patency-related reinterventions were 60% lower than arteriovenous grafts (AVGs) and 30% lower than arteriovenous fistulas (AVF), resulting in fewer access procedures for patients. The access-related infection rate at one year was 3%, substantially lower than the 22% rate for central venous catheters and 9% for AVGs.
Bioabsorbable Technology Promotes Tissue Regeneration
aXess (search) represents a novel approach to vascular access, functioning as a bioabsorbable graft that is injected under the skin and promotes the growth of a patient's own tissue to form a living, permanent blood vessel. According to Xeltis (search) CEO Eliane Schutte, "The data demonstrate that aXess is safe and easy to implant, and by 12 months transforms into a tissue-like, pulsating conduit."
Commercial Launch Planned Across Europe
With the CE mark approval secured, the Netherlands-based company intends to initiate commercial activities for its graft across Europe. Schutte noted, "With this level of clinical evidence, we can now move forward with the commercialisation of aXess (search) and begin delivering it to patients in real-world clinical practice."
Addressing Critical Need in Hemodialysis Care
Hemodialysis, the most common treatment for kidney failure, utilizes an external machine and dialyser to filter blood. The failure of vascular access represents a common and potentially life-threatening issue for individuals requiring regular hemodialysis treatment. However, industry participants highlight that securing dialysis clinic adoption for new technologies remains challenging, partly due to limited funding for kidney disease treatments.