Dr An de Vriese, who is playing a leading role in the ongoing European pivotal trial investigating the aXess vascular graft, discussed the study and the significant potential held by Xeltis’ technology in dialysis access care in Renal Interventions.
“The novel structure and mechanical properties of this new device offer promise to overcome the limitations of current graft options, while over time acquiring similar properties to those of a native fistula. This could fulfil a major unmet need in hemodialysis vascular access,” she explained in the article.
The AXESS EU pivotal trial is a multicentre trial with the objective to enrol 110 patients at up to 25 European sites and follow up with them for five years. Primary endpoints include freedom from device-related serious adverse events and primary patency at six months.
End-stage kidney disease (ESKD) patients requiring haemodialysis are exponentially increasing in number worldwide and the related economic burden is sizeable. Current options for vascular access still entail high complication rates.
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