The av-GuardianTM is the world’s first implant technology with the concept of establishing a “guardian guide-door” to facilitate dialysis needles to optimally access the dialysis vein without being in contact with the vein.
Receiving the CE Mark certificate indicates that av-GuardianTM conforms with health, safety, and environmental protection standards set by the European Union for a device to be distributed into the European Economic Area.
The technology is compatible with patients undergoing haemodialysis in various treatment settings whether in dialysis centres or at home, regardless of the types of dialysis machine used.
Providing reliable access to the dialysis vein, the arteriovenous fistula (AV fistula), remains one of the most stressful and challenging parts of haemodialysis. Moreover, during this procedure many complications can often arise due to poor needling, leading to inadequate dialysis or vascular access related hospitalizations.
Peh Ruey Feng, Chief Executive Officer and Founder of Advent Access, said, “Receiving CE Mark approval for av-GuardianTM 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 realize the impact we can make in potentially changing the way haemodialysis patients receive treatment both in-centre or at home.”
av-GuardianTM technology was recently evaluated in a first-in-man study conducted at the Singapore General Hospital and National University Hospital of Singapore, with the support from the National Kidney Foundation. The study conducted was a non-randomized, prospective clinical trial to access the safety and clinical performance of av-GuardianTM. Results of the study showed av-GuardianTM met all safety and performance endpoints across 216 haemodialysis sessions in patients with native AV fistula. Achieving a 94 to 98 per cent success rate in access to the AV fistula, and 86 to 90 per cent success at first needle attempt.
Today, an estimated 2.5 million patients suffer from end-stage renal disease (ESRD) and it is estimated that this figure will more than double to 5.5 million patients worldwide by 2030. 89 per cent of ESRD patients rely on haemodialysis to sustain their lives until a kidney transplant is received. The haemodialysis market is valued at USD$71 billion in 2017 and is forecasted to be worth USD$99 billion by 2025.
Advent Access is focused on developing solutions to address the rising cost of operating in-centre haemodialysis and the limited scalability of dialysis centres when they reach maximum capacity. [APBN]