Advent Access wins CE Mark for dialysis device

The av-Guardian vascular access system designed for hemodialysis patients. (Image from Advent Access) 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...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Business/Financial News Dialysis Featured News Well Regulatory/Compliance Advent Access CE Mark Source Type: news