Xeltis receives IDE approval from FDA for initiation of US pivotal trial for aXessTM, its restorative vascular access conduit

  • aXess is a restorative arteriovenous dialysis conduit which allows vascular access for hemodialysis through the creation of a new, permanent, living vessel

EINDHOVEN, The Netherlands, 13 June 2024 – Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces that it has gained approval from the US Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) submission to begin enrolling patients into a pivotal study for aXess.

aXess is a restorative conduit that enables the creation of a new, permanent, living vessel for hemodialysis vascular access, combining the safety and patency of an arteriovenous fistula (AVF), with the speed to treatment of an arteriovenous graft (AVG). The aXess vascular access conduit offers an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by many renal disease patients.

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