Xeltis’ aXess Gains FDA Breakthrough Device Designation

Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, has received Breakthrough Device Designation status from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the aXess conduit.

Following IDE approval from the FDA, the first patient in aXess’ US-staged pivotal trial has been enrolled and treated at the Flow Vascular Institute in Houston, Texas, by Dr. Karl Illig.

aXess is Xeltis’ vascular access conduit, which enables the creation of a new, permanent, living vessel for hemodialysis vascular access.

This Breakthrough Device Designation acknowledges that aXess meets the necessary criteria for its proposed use as a vascular prosthesis and that it has the potential to provide a more effective treatment option for patients needing hemodialysis vascular access than current treatments. These benefits include the avoidance of frequent reinterventions and complications, such as infections, which are faced by renal disease patients.

Eliane Schutte, Chief Executive Officer, Xeltis commented, “We are in a transformative period for Xeltis, and this designation from the 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 commercialization.”

The designation grants Xeltis accelerated interactions with FDA review teams, prioritized review, and special reimbursement consideration, positioning the company for enhanced market access and expediting commercialization for patients in need.

Dr. Karl Illig, Vascular Surgeon and site Principal Investigator for aXess US pivotal trial, said, “aXess has the potential to be a truly groundbreaking 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.”