Blue granted CE mark for Protégé NC DEB
Blue Medical has been granted CE mark approval for ProtÃ©gÃ© NC, a non-compliant drug-eluting balloon (DEB) for the treatment of in-stent restenosis (ISR). The device will now be launched worldwide. The CE marking follows the introduction of Blue's CE-marked DEB, ProtÃ©gÃ©, and CoCr stent on DEB, Pioneer, in March 2012. Blue will continue to develop its DEB technologies into additional applications both for coronary and peripheral applications.
Non-compliant percutaneous transluminal coronary angioplasty (PTCA) balloons are commonly used to post-dilatate stents and to treat ISR. With the introduction of DEBs medication was added to PTCA balloon treatments, leaving a gap in the need for precise and powerful dilatation. Combining a DEB with the characteristics of the treatment advantages of a non-compliant balloon, Blue says it has combined safe and reproducible drug-delivery with precise and powerful dilatation in one device. In addition, profile and flexibility of a normal workhorse PTCA balloon are maintained, making the device reportedly easy to work with.