Tag: Xeltis

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...

Xeltis secures additional €12.5 million from European Innovation Council

Xeltis has announced the closing of an additional €12.5 million in funding from the European Innovation Council (EIC) Fund, set up by the European...
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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 secures funding to progress clinical trials

Xeltis has raised €32 million in a Series D2 equity fundraise, backed by a syndicate of current and new investors, which the company says...
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Interventional News’ top 10 most popular stories of October 2022

Interventional News’ most popular content last month featured a report on the need for greater interventional radiology (IR) service coverage in rural areas of...

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...