EINDHOVEN, The Netherlands, July 2, 2026
Xeltis announced that it has surpassed 50% patient enrollment in its U.S. pivotal clinical trial evaluating aXess™, the company’s investigational bioabsorbable vascular access device designed for adults with end-stage renal disease (ESRD) requiring hemodialysis. The prospective, multicenter study is assessing the patency, safety, and performance of the device across 20 clinical sites in the United States, with more than half of the planned 140-patient enrollment now completed. The milestone represents significant progress toward completing patient recruitment and advancing the study toward potential FDA approval. Supported by the FDA Breakthrough Device Designation granted in November 2024, the trial is evaluating aXess™ in a real-world population of complex hemodialysis patients, aiming to address the ongoing need for durable and reliable vascular access solutions.
Pivotal Trial Evaluates Safety and Performance in ESRD Patients
The U.S. pivotal trial is designed to evaluate whether aXess™ can provide safe and effective long-term vascular access for patients undergoing chronic hemodialysis. The study is enrolling adults with ESRD who require dependable dialysis access and is measuring key clinical outcomes including vascular patency, device safety, and overall performance. Conducted across multiple centers, the trial reflects routine clinical practice and is intended to generate robust evidence supporting future regulatory submission. According to Shawn Gage, Vice President of U.S. Clinical Affairs at Xeltis, surpassing the halfway enrollment mark highlights the commitment of investigators, clinical teams, and participating patients while maintaining momentum toward completion of the pivotal study.
Positive European Clinical Data Strengthens Development Program
The ongoing U.S. study builds on encouraging 12-month clinical results from Xeltis’ European pivotal trial, which demonstrated that aXess™ achieved higher secondary patency than historical benchmarks for conventional arteriovenous grafts (AVGs) while delivering performance comparable to mature arteriovenous fistulas. The European study also reported lower reintervention rates and enhanced resistance to infection, supporting the device’s potential to improve long-term outcomes for dialysis patients. These positive clinical findings contributed to CE Mark approval, allowing commercialization in Europe and providing additional evidence supporting the continued advancement of the U.S. clinical program.
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Clinical Development Advances Innovative Hemodialysis Technology
aXess™ is designed to transform from a bioabsorbable implant into a patient’s own living blood vessel, offering a regenerative approach to vascular access rather than relying on permanent synthetic grafts. This innovative technology has the potential to reduce complications associated with conventional dialysis access while improving long-term durability and patient outcomes. With enrollment now exceeding 50% of the planned study population, Xeltis continues to make important progress toward completing its U.S. pivotal clinical trial and generating the evidence needed for regulatory review. If successful, aXess™ could become a novel treatment option for patients with end-stage renal disease, providing a durable vascular access solution that supports safer and more effective long-term hemodialysis treatment.
Source: Xeltis press release
