Blue granted CE mark for Protégé NC DEB

Blue Medical has been granted CE mark approval for Protégé 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, Protégé, 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.

Blue granted CE mark for Protégé NC DEB

Blue Medical has been granted CE mark approval for Protégé 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, Protégé, 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.

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