CryoLife has announced the first European clinical implant of its HeRO (Haemodialysis Reliable Outflow) graft following its CE Mark in June 2013.
The procedure was performed at the University of Leuven Hospital in Belgium by Professor Inge Fourneau, a vascular surgeon, and Professor Sam Heye, an interventional radiologist, in collaboration with nephrologist team.
The HeRO graft is intended for catheter dependent end stage renal disease (ESRD) patients on hemodialysis who have exhausted all other access options, such as AV fistulas and grafts (AVFs and AVGs).
In all the clinical trials to-date, the graft has shown to reduce the rate of infection as compared to tunneled dialysis catheters with improved patient quality life.
CryoLife chairman, president and CEO Steven G Anderson noted the company will begin commercialization of the HeRO graft in Europe.
"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," Anderson added.
CryoLife expects to conduct a controlled market launch of the graft during in the second half of 2013, followed by a broader European rollout next year.
The HeRO graft received its initial US FDA 510(k) clearance in 2008 and initial CE Mark in 2011.