We’ve been following the progress of CryoLife, Inc.’s HeRO® (Hemodialysis Reliable Outflow) Graft for a while. Now the company has announced that the first European clinical implant of the Company’s HeRO has been performed. The procedure was performed at the University of Leuven Hospital in Belgium by vascular surgeon Professor Inge Fourneau, and Professor Sam Heye, an interventional radiologist.
The HeRO Graft received its initial FDA 510(k) clearance in 2008 and initial CE Mark approval in 2011, followed by full approval in June of this year as we reported. It is indicated for catheter dependent ESRD patients on long-term hemodialysis who have exhausted all other access options, such as AV fistulas and grafts (AVFs and AVGs). Prior to the introduction of the HeRO Graft, the only option for these patients was access through percutaneous tunneled dialysis catheters (TDCs), which are higher cost, have high infection rates, limit a patient’s lifestyle, and foster central venous stenosis, or narrowing. The HeRO Graft overcomes the limitations of TDCs by providing a completely subcutaneous graft that functions like a regular access graft during dialysis and provides superior blood flow and a 69 percent reduction in bacteremia (bacteria in the blood) compared with TDCs.
HeRO Graft is the only subcutaneous AV access solution clinically proven to maintain long-term access for hemodialysis patients with central venous stenosis.
Professor Fourneau and Professor Heye commented, “It is exciting to be the first hospital in Europe to offer the innovative benefits of the HeRO Graft to dialysis patients with end-stage renal disease in our local community. Based on the clinical results to-date in the U.S., we believe the HeRO Graft will reduce the rate of infection as compared to tunneled dialysis catheters and improve patient quality of life.”
Steven G. Anderson, chairman, president and CEO of CryoLife, said, “We are pleased to begin commercialization of the HeRO Graft in Europe and would like to thank Professor Fourneau and Professor Heye for performing the procedure. Over the remainder of the year we will train additional physicians on the procedure, which will support a broader launch in Europe beginning in 2014. We continue to believe the HeRO Graft represents a significant opportunity to provide a better dialysis access option for patients with end-stage renal disease and that it will be a growth driver for the Company.”
Source: CryoLife, Inc., PR Newswire