The European Union has granted CE mark certification to Blue Medical Devices' non compliant, high pressure drug eluting balloon (DEB).
The new Protege NC device incorporates medication added to non compliant PTCA balloon, designed to post-dilatate stents and treat in stent restenosis.
Blue Medical CTO and CFO Ronald Horvers said combining a drug eluting balloon with the characteristics of the proven treatment advantages of a non compliant balloon is a logical next step.
"With Protégé NC we succeeded in combining safe and reproducible drug delivery with precise and powerful dilatation in one device," Horvers added.
"Thus reducing on the one hand procedural costs and post procedural medication requirements and at the same time increasing procedure efficiency, safety and patients’ comfort.
"In addition to these advantages the performance, profile and flexibility of a normal workhorse PTCA balloon are maintained, making the device easy to work with."
Blue Medical CEO Noel Coopmans said the development of new DEB technologies into additional applications both for coronary and peripheral application will contribute to the further growth of the company in the years ahead.