Xeltis has announces that it has received CE mark for aXess, its restorative vascular access conduit for haemodialysis treatment.
The CE mark was granted following evaluation of all data including Xeltis’ European clinical pivotal trial results and was achieved in just 84 working days from submission, well ahead of schedule, reflecting the strength and completeness of the clinical evidence package, the company says in a press release.
The device leverages Restorex materials, which triggers the body’s natural healing response to transform into the patient’s own tissue to form a living vessel for reliable vascular access. aXess is designed to reduce long-term catheter dependence and access issues—aiming to shift the haemodialysis journey for patients with end-stage kidney disease from repeated interventions toward more seamless care delivery and improved quality of life.
With CE marking in place, Xeltis can commercialise across European markets, enabling clinicians to confidently deploy aXess and allowing patients to benefit from an innovation that meets high standards of safety, performance and clinical evidence.
Eliane Schutte, CEO of Xeltis, commented: “Receiving CE mark approval for aXess is a defining moment for Xeltis and a strong validation of our revolutionary restorative technology platform and the outstanding dedication of the entire Xeltis team. For patients undergoing haemodialysis, this milestone means we can offer a more reliable, long‑lasting access option that can improve quality of life while reducing the burden of ongoing procedures. Achieving CE mark in just 84 working days underscores the strength of our clinical data and marks our transition from a clinical‑stage company to a commercial organisation.”
Ferdinando Lamagna, spokesperson at the British Standards Institution (BSI), said: “At BSI, it is a pleasure to support medtech organisations that bring meaningful innovation to the sector and ultimately benefit patients. Xeltis demonstrated a high level of preparation and a collaborative approach throughout the conformity assessment process, which progressed in an efficient and well-structured manner, with effective coordination between the parties. As a result, certification of this class III implantable device was achieved within a notably short timeframe, taking into account the scope and complexity of the assessment, including a full Clinical Evaluation Consultation Procedure per MDR [Medical Device Regulation] article 54. We congratulate the Xeltis team on this important achievement and look forward to continuing our collaboration to support innovation in patient care.”
