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.
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