Tag: axess

Xeltis completes enrolment in EU pivotal trial

Xeltis has announced the completion of enrolment in its EU pivotal trial for aXess, its restorative vascular access conduit, in adults with end-stage renal...

Xeltis announces US FDA Breakthrough Device Designation for aXess and first...

Xeltis has today announced that the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has granted aXess...

Xeltis receives IDE approval from US FDA for haemodialysis vascular access...

Xeltis has announced that it has gained approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) submission to...
TOP 10

Interventional News’ top 10 most popular stories of May 2023

Interventional News’ most popular stories from May included a forecast of where embolization is headed from a Global Embolization Oncology Symposium (GEST, 18­–21 May,...

Xeltis presents six-month first-in-human data on aXess graft

Xeltis has presented “highly-encouraging” six-month data from its first-in-human (FIH) aXess vascular graft trial at the 13th Congress of the Vascular Access Society (VAS;...

Xeltis starts pivotal clinical trial of “first-ever” restorative synthetic haemodialysis access...

Xeltis announced today the initiation of a pivotal trial with the “first-ever” restorative synthetic haemodialysis access grafts, dubbed ‘Axess’. The first two patients have been...

Xeltis presents “promising” first-in-human data on restorative haemodialysis access graft

Xeltis today announced what it describes as “very promising” preliminary efficacy and safety results from one of the centres participating in the AXESS study—a...