Blue Medical’s drug eluting balloon Protégé receives CE mark

Blue Medical, the global medical device company and innovator in the treatment of vascular diseases, today announced receiving the CE mark for Protégé NC, a non compliant drug eluting balloon. The new device will be launched worldwide. It follows the introduction of Blue Medical's CE marked Drug Eluting Balloon Protégé and CoCr Stent on Drug Eluting Balloon Pioneer in March of this year. Blue Medical will continue to develop their novel DEB technologies into additional applications both for coronary and peripheral application.

Non compliant PTCA balloons are commonly used to post-dilatate stents and to treat in stent restenosis (ISR). With the introduction of Drug Eluting Balloons medication was added to PTCA balloon treatment. Leaving a gap in the need for precise and powerful dilatation. "Combining a drug eluting balloon with the characteristics of the proven treatment advantages of a non compliant balloon is a logical next step," said Ronald Horvers, Blue Medical's CTO and CFO. "With Protégé NC we succeeded in combining safe and reproducible drug delivery with precise and powerful dilatation in one device. 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."

"This new non compliant DEB completes the coronary drug eluting product line of Blue Medical", said Noel Coopmans, CEO. "It's another landmark in the company's history of developing unique and innovative products. I trust it will contribute to the further growth of Blue Medical in the years ahead."