ClearStream Technologies have announced that it has received approval from the US Food and Drug Administration (FDA) for the sale in the United States of its ground-breaking ReeKross family of catheters.
ClearStream is an innovative designer and manufacturer of specialist medical devices including catheters and drug-eluting stents used in interventional procedures.
The ReeKross is used in the treatment of critical limb ischemia. It was developed under ClearStream’s research and development programme which is supported by Enterprise Ireland.
Andrew Jones, Chief Executive of ClearSteam Technologies, said: “This FDA approval is potentially one of the most exciting developments for ClearStream in that it enables us to supply the largest market in the world for peripheral catheters.
“It gives significant additional impetus to our drive to build and develop ClearStream as one of the world’s leading suppliers of innovative devices for the treatment of critical limb ischemia and diabetic foot.
“US healthcare systems are well developed and organised for interventional treatment of these conditions, and we now have approval to supply some of the most effective products available on the market.”