Matteo Tozzi, Jan De Letter, Dainis Krieviņš, Janis Jushinskis, Annick D’Haeninck, Kęstutis Ručinskas, M. Miglinas, Tomas Baltrūnas, Sigi Nauwelaers, Frederick J. Schöen, Renu Virmani, An S. De Vriese, Frans L. Moll, Frank Vermassen
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.