Xeltis announces FDA Breakthrough Device Designation for aXess and first patient treated in US pivotal trial
- Designation recognizes aXess has the potential of providing a more effective vascular access option for dialysis patients, bringing significant advantages over current therapies
- First patient treated in US pivotal trial, marking significant clinical milestone
EINDHOVEN, The Netherlands, 14 November 2024 – Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces that the Center for Devices and Radiological Health (CDRH) of the 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 hemodialysis vascular access.
