Blue Medical (Helmond, The Netherlands) received CE Mark approval for its Protégé NC non compliant drug eluting balloon. It’s used to post-dilatate stents and to treat in stent restenosis.
Paclitaxel is embedded in the balloon’s hydrophilic coating that is only released once the balloon makes contact with the vessel wall.
More about the balloon from the announcement:
With the introduction of Drug Eluting Balloons medication was added to PTCA balloon treatment. But the need for precise and powerful dilatation remained. “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.”
Product page: Protégé NC Blue Medical…
Press release: Blue Medical Devices announces the CE marking of their non compliant, high pressure, drug eluting balloon Protégé NC
(hat tip: MassDevice)