Hemosphere has obtained CE mark approval and ISO 13485 certification for its Hemodialysis Reliable Outflow (HeRO) Graft which restores quality of life for end-stage renal disease patients with compromised vasculature.
HeRO Graft is used as an alternative for patients using catheters for ESRD Hemodialysis and is implanted completely under the skin, which reduces infection risk.
The HeRO Graft is clinically proven to reduce infections by 69% compared to hemodialysis catheters.
Hemosphere Quality and Regulatory Assurance head Laurie Lynch said these certifications show the company has met the clinical, quality, and performance requirements of the Medical Device Directives (MDD) and the quality systems the company has in place achieve the standards required by the MDD.