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Xeltis announces US FDA Breakthrough Device Designation for aXess and first patient treated in US pivotal trial - Interventional News

Summary by Interventional News
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-…
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