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Xeltis receives IDE approval from FDA for initiation of US pivotal trial for aXess™, 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, June 13, 2024 /PRNewswire/ — 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.

Xeltis’ groundbreaking implants platform is an important development in vascular replacement technology as, over time, its implants are gradually replaced by the patients’ own living healthy tissue. Xeltis’ novel technology has already treated over 100 patients across different clinical trials.

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