ClearStream Technologies out of Wexford, Ireland has received FDA approval for its ReeKross line of catheters.
The ReeKross is used in the treatment of extreme cases of critical limb ischaemia where the lesions in the vessel have become very heavily calcified. This condition often cannot be treated using angioplasty catheters of traditional designs and materia ls because the lesion is impassable. Untreated the condit ion typically results in the amputation of the patient’s lower limb.
In a recent study led by Professor Reekers of the University Hospital of Amsterdam and conducted in 5 hospitals in Holland and Ireland, the Reekross substantially outperformed all other catheters evaluated through its ability to cross these chronically blocked lesions and in the durability of the balloon. Often balloons used in these types of procedures burst due to the heavy calcification. No ReeKross balloons burst during this study.