Advent Access has received the CE mark for its av-Guardian vascular access system. A press release reports that the av-Guardian is the world’s first implant technology to pioneer the concept of establishing a “guardian guide-door” to facilitate dialysis needles to optimally access an arteriovenous (AV) fistula, without being in contact with the vein. It adds that the technology is compatible with patients undergoing haemodialysis in various treatment settings—in dialysis centres or at home, regardless of the types of dialysis machine being used.
The av-Guardian technology was recently evaluated in a first-in-man study conducted at Singapore General Hospital and National University Hospital of Singapore, with support from the National Kidney Foundation. The study was a non-randomised, prospective clinical investigation to assess the safety and clinical performance of the av-Guardian across 216 haemodialysis sessions in patients with native AV fistulas.
The study showed that av-Guardian met all safety and performance endpoints. In particular, the av-Guardian achieved 94–98% successful access to the AV fistula, with 86–90% success at the first needle attempt.
Peh Ruey Feng, CEO and founder of Advent Access, says: “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.”