Blue Medical Devices wins CE Mark approval in the European Union for its next-generation Protégé NC drug-eluting balloon.
Netherlands-based vascular devices maker Blue Medical Devices announced a European regulatory win for its next-generation Protégé NC drug-eluting balloon.
The Protégé NC, a descendant of the company's Protégé DEB, is designed for stent post-dilation and to treat in-stent restenosis, according to a press release.
"This new non compliant DEB completes the coronary drug eluting product line of Blue Medical," Blue Medical CEO Noel Coopmans said in prepared remarks. "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."
The new Protégé NC may be able to reduce procedure-related costs and post-procedure medication requirements by combining a a drug-eluting balloon with non-compliant balloon technology, according to the company.
"With Protégé NC we succeeded in combining safe and reproducible drug delivery with precise and powerful dilatation in one device," Blue Medical CTO & CFO Ronald Horvers said in prepared remarks. "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 plans to launch the new device worldwide.
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