Medical device maker CryoLife won European regulatory approval for its HeRo graft system, the win coming on the heels of a FDA clearance for HeRo’s next generation adapter. Atlanta, Ga.-based CryoLife said a staged product roll-out in Europe will begin next month.
CyroLife’s next-generation HeRo system is for treatment of patients with end-stage renal disease undergoing hemodialysis. The 1st patients will be treated with HeRo in Europe in July, followed by a controlled market introduction in the last half of 2013 and a full launch in Europe in 2014, according to the company.
The company also recently landed a green light from the FDA for its HeRo adaptor that connects to CryoLife’s proprietary venous outflow to other dialysis grafts, including early access grafts.
“We believe [the HeRo Graft] will be well received in Europe because it is clinically proven to reduce infection rates by 69 percent as compared to tunneled dialysis catheters, which is a benefit for patients and government payors," CEO Steven Anderson said in a statement. "We have received positive feedback on the Hero Graft from European physicians at medical meetings in Europe and the United States."
