The CE mark approval allows the company to distribute av-Guardian vascular access system for the customers in the European Economic Area.
The av-Guardian is claimed to be the world’s first implant technology to initiate the concept of establishing a guardian guide-door to facilitate dialysis needles for maximum access to the dialysis vein, an arteriovenous fistula (AV fistula), without being in contact with the vein.
Advent Access’ new technology can be used with patients undergoing hemodialysis in various treatment settings, including dialysis centres or at home.
The company has developed av-Guardian implant technology to improve vascular access reliability, enable less-painful self-cannulation and reduce vascular access related hospitalisations.
Recently, the av-Guardian technology has been assessed in a first-in-man study carried out at Singapore General Hospital and National University Hospital of Singapore, through taking support from the National Kidney Foundation.
The non-randomised and prospective clinical investigation study was designed to evaluate the safety and clinical performance of the av-Guardian across 216 hemodialysis sessions in patients with native AV fistulas.
According to the company, the study demonstrated that safety and performance endpoints, as well as achieved 94%-98% successful access to the AV fistula, with 86% -90% success at the first needle attempt.
Advent Access CEO and founder Peh Ruey Feng said: :“Receiving CE Mark approval forav-GuardianTMis an important milestone in ourmission to provide a more comfortable treatment for patients suffering long term end-stage kidney diseaseand 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 hemodialysis patients receive treatment both in-centre or at home.”
Advent Access, which is a Stanford StartX company and spin-off from A*STAR, aims to develop solutions to significantly reduce dialysis cost and restore quality of life for kidney failure patients.
