Hemosphere has received CE mark and ISO 13485 Certification for its Hero Graft, a vascular access graft for haemodialysis patients.
The Hero (Hemodialysis reliable outflow) Graft is clinically proven to reduce costly infections by 69% compared to haemodialysis catheters. The Hero Graft is an alternative to catheters for ESRD haemodialysis “catheter-dependent” patients with central venous stenosis. Since its introduction, over 4,000 haemodialysis patients have received the Hero Graft in the United States.
Unlike catheters, the Hero Graft is implanted completely under the skin, which reduces infection risk. Utilising endovascular techniques, the venous outflow component is placed in the central venous vasculature with the radiopaque distal tip sitting in the mid-to-upper right atrium.
“CE mark approval for the Hero Graft allows us to build upon the already successful commercialisation of the Hero Graft in the USA,” said Patrick Wethington, Hemosphere president and CEO.