TY - JOUR
T1 - Endogenous tissue restoration in a hemodialysis conduit
T2 - Performance and safety after 1-year of follow-up
AU - Tozzi, Matteo
AU - De Letter, Jan
AU - Krievins, Dainis
AU - Jušinskis, Jānis
AU - D’Haeninck, Annick
AU - Rucinskas, Kestutis
AU - Miglinas, Marius
AU - Baltrunas, Tomas
AU - Nauwelaers, Sigi
AU - Schoen, Frederick J.
AU - Virmani, Renu
AU - De Vriese, An S.
AU - Moll, Frans
AU - Vermassen, Frank
N1 - Publisher Copyright:
© The Author(s) 2025
PY - 2025/11
Y1 - 2025/11
N2 - 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.
AB - 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.
KW - arteriovenous graft
KW - aXess
KW - endogenous tissue restoration
KW - Hemodialysis
KW - patency
KW - vascular access
UR - https://www.scopus.com/pages/publications/105022614927
UR - https://pubmed.ncbi.nlm.nih.gov/41272425/
U2 - 10.1177/11297298251395823
DO - 10.1177/11297298251395823
M3 - Article
AN - SCOPUS:105022614927
SN - 1129-7298
JO - Journal of Vascular Access
JF - Journal of Vascular Access
ER -