Xeltis, a leading developer of transformative implants, has received approval from the US Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) submission. This approval allows Xeltis to begin enrolling patients into a pivotal study for their innovative product, aXess.

aXess is a restorative conduit designed to create a new, permanent, living vessel for hemodialysis vascular access. It combines the safety and durability of an arteriovenous fistula (AVF) with the quick treatment initiation of an arteriovenous graft (AVG).

The aXess vascular access conduit aims to enhance the dialysis experience for patients and reduce the need for frequent reinterventions and complications, such as infections, commonly faced by those with renal disease.

Xeltis' groundbreaking implant platform represents a significant advancement in vascular replacement technology. Over time, their implants are gradually replaced by the patient's own healthy tissue.

This novel technology has already been used to treat over 100 patients in various clinical trials.

"Have already demonstrated excellent 12-month data from our first-in-human study in Europe, and we are excited to commence this pivotal trial in the US. We are proud of the potential for aXess to revolutionize vascular access by breaking the cycle of interventions and infections, and we look forward to offering our unique restorative solution to hemodialysis patients worldwide."

"Goal is to improve outcomes for dialysis patients. aXess has the potential to achieve this by minimizing the reinterventions and complications associated with other vascular access solutions.

This pivotal study is crucial in evaluating and proving this potential and represents a significant milestone in our clinical strategy in the US."

The US-based pivotal trial follows promising 12-month data from the initial human trial in Europe, where aXess showed favorable comparisons to existing hemodialysis vascular access solutions. Additionally, aXess is currently undergoing a pivotal trial in the EU, with plans to recruit up to 110 patients across nine European countries.

 

 

 

 

 

 

Source: prnewswire.com

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