Endogenous tissue restoration in a hemodialysis conduit: Performance and safety after 1-year of follow-up

Background: Xeltis’ aXess hemodialysis (HD) conduit is a novel arteriovenous graft (AVG) made of bioabsorbable polymer, replaced by body-own tissue, through endogenous tissue restoration (ETR). Methods: An ongoing prospective, single-arm, multi-center first-in-human (FIH) study evaluates safety and performance in hemodialysis patients unsuitable for arteriovenous fistula (AVF) creation. Primary and secondary 12-months outcomes are reported. Results: The aXess conduit was implanted in 20 patients. Freedom from device-related serious adverse events (SAEs) was 100% at 6 months and 95% at 12 months, with no access-related infections. Two unrelated deaths occurred. Primary and secondary patency rates were 80% and 100% at 6 months, 39% and 100% at 12 months. Access-related interventions occurred in 61% of patients, mainly for thrombosis and stenosis (71%), and pseudoaneurysms (29%). Histology showed remodeling at 6 months; the polymer was almost resorbed at 15 months. Conclusions: This bioengineered conduit shows favorable safety and performance for 1 year. However, long-term validation in a pivotal trial is warranted. Trial Registration: First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess-FIH) (https://www.clinicaltrials.gov); Unique identifier: NCT04898153.