Singapore-based Advent Access has received the CE-Mark for its av-Guardian vascular access system, authorising its distribution in the European Economic Area.
An implant technology, av-Guardian is based on a ‘guardian guide-door’ concept to optimally access an arteriovenous fistula (AV fistula) without being in contact with the dialysis vein.
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Appropriate access to the AV fistula is considered as one of the most challenging steps of haemodialysis.
Various complications can occur due to poor needling which may result in inadequate dialysis or vascular access-related hospitalisations.
According to Advent Access, av-Guardian gets fully embedded under the skin and is meant to offer a less-painful approach for vascular access, allowing more comfortable haemodialysis.
The device is said to be compatible with a range of haemodialysis treatment settings, including dialysis centres or at home, irrespective of the type of machine used.
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By GlobalDataAdvent Access CEO and founder Peh Ruey Feng said: “Receiving CE-Mark approval for av-Guardian is an important milestone in our mission to provide a more comfortable treatment for patients suffering long term end-stage kidney disease and to reduce the cost burden of maintenance dialysis.
“Our focus now is to work with high-quality manufacturing and distribution partners to realise the impact we can make in potentially changing the way haemodialysis patients receive treatment both in centre or at home.”
A non-randomised, prospective clinical study was recently performed at Singapore General Hospital and National University Hospital of Singapore to test the safety and clinical performance of the vascular access system across 216 haemodialysis sessions.
The study, which involved patients with native AV fistulas, met all safety and performance endpoints.
Data showed that av-Guardian achieved 94% to 98% successful access to the fistula, with 86% to 90% success at the first needle attempt.
