Xeltis has today announced that the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has granted aXess Breakthrough Device Designation status. aXess is Xeltis’ vascular access conduit, which enables the creation of a new, permanent, living vessel for haemodialysis vascular access.
Concurrently, following investigational device exemption (IDE) approval from the US FDA, the first patient in aXess’ US-staged pivotal trial has now been enrolled and by Karl Illig (FLOW Vascular Institute, Houston, USA), marking a significant clinical milestone for Xeltis.
According to the press release, this Breakthrough Device Designation acknowledges that aXess meets the necessary criteria for its proposed use as a vascular prosthesis, as well as the fact that it has the potential of providing a more effective treatment option for patients needing haemodialysis vascular access than current treatments. These benefits, Xeltis said, include the avoidance of frequent reinterventions and complications, such as infections, which are faced by renal disease patients. The designation grants Xeltis accelerated interactions with US FDA review teams, prioritised review, and special reimbursement consideration, positioning the company for enhanced market access and expediting commercialisation for patients in need.
Eliane Schutte, chief executive officer (CEO) of Xeltis commented: “We are in a transformative period for Xeltis, and this designation from the US FDA is great recognition of the potential importance of our highly novel technology. We are also extremely proud that the first patient in our US pivotal trial has now been treated, and this clinical achievement provides us with significant momentum as we advance towards commercialisation.”
Illig, site principal Investigator for aXess US pivotal trial, also shared his thoughts, stating: “aXess has the potential to be a truly ground-breaking advance in the vascular access field, as it enables the creation of a new, permanent, living vessel. We hope that its ability to avoid the frequent reinterventions and infections associated with current treatment options will make a major difference to patients and their care.”
John Lucas III (Greenwood Leflore Hospital, Greenwood, USA), national principal investigator for aXess US pivotal trial, added: “The US trial for aXess is an important step in assessing and validating the ability of this unique conduit to transform the field of vascular access. The 12-month data from the first-in-human study in Europe is extremely promising and I look forward to working on this next clinical stage in Xeltis’ journey.”
Strong clinical data for aXess will be presented during the VEITH Symposium (19-23 November, New York, USA). On 21 November, Frans Moll (University Medical Center Utrecht, Utrecht, The Netherlands) will present the full two-year clinical results for aXess, and on 23 November, Lucas III will present an update on the US IDE Pivotal Study for aXess.
