Research & Development
Xeltis' aXess Investigational Device Exemption (IDE) submission receives US FDA approval
14 June 2024 -

Xeltis, a Netherlands-based developer of transformative implants, announced on Thursday that it has gained approval from the US Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) submission to begin enrolling patients for a pivotal study of aXess.

The company says that aXess is a restorative conduit that enables the creation of a new, permanent, living vessel for haemodialysis 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 is claimed to offer an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by many renal disease patients.

Xeltis adds that its 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.

Eliane Schutte, Xeltis chief executive officer, commented: 'We have already shown outstanding 12-month data from our first-in-human study in Europe and are looking forward to starting this pivotal trial in the US. We are very proud of the potential for aXess to transform the field of vascular access by stopping the cycle of interventions and infections and bringing our unique restorative solution to haemodialysis patients worldwide.'

The US-based pivotal trial follows strong 12-month data from the first-in-human trial in Europe in comparison to haemodialysis vascular access solutions. aXess is also undergoing an EU pivotal trial, recruiting up to 110 patients in nine EU countries.