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June 13, 2024
Xeltis’ aXess Restorative Conduit to Be Studied in FDA IDE Pivotal Trial
June 13, 2024—Xeltis announced that it has gained FDA approval for an investigational device exemption submission to begin enrolling patients into a pivotal study for the company’s aXess device.
According to Xeltis, the aXess device combines the safety and patency of an arteriovenous fistula with the speed to treatment of an arteriovenous graft. It features the company’s endogenous tissue restoration platform and utilizes a polymer implant that regenerates the patient’s own tissue before gradually being absorbed and leaving new, living and long-lasting vessels in place, stated Xeltis.
The US-based pivotal trial comes after the first-in-human trial in Europe of the aXess vascular conduit, which demonstrated a significant improvement in performance compared to hemodialysis vascular access solutions. The aXess device is also undergoing a European Union pivotal trial that is recruiting up to 110 patients in nine countries.
In November 2013, the company announced 12-month data from the FIH trial including 100% secondary patency, 78% primary assisted patency, and 0% infections in 20 patients implanted with the aXess conduit.
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