Singapore-based vascular access device company Advent Access said it has received the CE Mark for its av-Guardian technology designed to create vascular access for dialysis patients.
The device-guided needling platform features the company’s “guardian guide-door” technology for accessing arteriovenous fistulas, which it claims can reduce wear and tear on the dialysis patient’s veins. The technology may be used in a dialysis center or at home, regardless of the types of dialysis machine being used, according to the company
“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,” Advent Access CEO Peh Ruey Feng said in a news release. “Our focus now is to work with high-quality manufacturing and distribution partners to realize the impact we can make in potentially changing the way hemodialysis patients receive treatment either in the center or at home.”
The av-Guardian technology was recently evaluated in a first-in-human study conducted at Singapore General Hospital and National University Hospital of Singapore, with support from the National Kidney Foundation. The study was a non-randomized, prospective clinical investigation to assess the safety and clinical performance of the av-Guardian across 216 hemodialysis sessions in patients with native AV fistulas. The study showed that av-Guardian met all safety and performance endpoints, achieving 94% to 98% successful access to the AV fistula, with 86% to 90% success at the first needle attempt, according to the company.
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