A new vascular access graft for haemodialysis patients has received CE Mark and ISO 13485 certification for sale in the EU.
The HeRO (Haemodialysis Reliable Outflow) Graft from US company Hemosphere is an alternative to catheters for “catheter-dependent” patients with end-stage renal disease causing central venous stenosis.
Unlike haemodialysis catheters, the HeRO Graft is implanted completely under the skin – which has been shown to reduce infection rates by 69%.
Over 4,000 haemodialysis patients have so far received the HeRO Graft in the US.
“CE Mark approval for the HeRO Graft allows us to build upon the already successful commercialization of the HeRO Graft in the US,” said Patrick Wethington, President and CEO of Hemosphere.
“Receiving CE and ISO 13485 certification demonstrates the commitment Hemosphere has towards developing world-class quality systems and auditing processes that position us for future incremental sales growth.”
Hemosphere specialises in technologies to improve care and quality of life for end-stage renal disease patients with compromised vasculature.