CryoLife, a tissue processing and medical device company focused on cardiac and vascular surgery, has received CE (Conformite Europeenne) Mark for the HeRO (Hemodialysis Reliable Outflow) Graft system produced at its facility in Atlanta.
HeRO Graft is meant for catheter dependent ESRD patients on long-term hemodialysis who do not have any access options, such as AV fistulas and grafts (AVFs and AVGs).
Before the introduction of the HeRO Graft, the only option for such patients was access through percutaneous tunneled dialysis catheters (TDCs), which are expensive, have high infection rates and foster central venous stenosis, or narrowing.
However, the HeRO Graft overcomes these limitations of TDCs by offering a fully subcutaneous graft that functions like a regular access graft during dialysis and provides superior blood flow besides a 69% reduction in bacteremia (bacteria in the blood) compared with TDCs.
The first HeRO Graft clinical cases in Europe are expected to be performed in July 2013.
The firm expects for a broader European launch of the device in 2014. The company estimates the European market potential for the HeRO Graft to be approximately $30m.
It received its initial FDA 510(k) clearance in 2008 and initial CE Mark approval in 2011. The graft has been implanted in over 6,000 patients till date.