Endogenous tissue restoration in a hemodialysis conduit: Performance and safety after 1-year of follow-up
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: 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.
Source: The Journal of Vascular Access
Institutions: University of Insubria, AZ Sint-Jan, Pauls Stradiņš Clinical University Hospital, Ghent University Hospital, Vilnius University, Vilnius University Hospital Santariskiu Klinikos, Ziekenhuis Oost-Limburg, Brigham and Women's Hospital, Harvard University, CVPath Institute, University Medical Center Utrecht
Language: English
Subfield: Emergency Medical Services
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4416531076