In July 2014, Boston Scientific Corp. CE marked its Ranger paclitaxel-coated balloon catheter for the treatment of peripheral artery disease (PAD), and immediately set about marketing the product throughout Europe. Drug-eluting balloons (DEBs) like the Ranger have become one of the most promising technologies for the treatment of PAD, and the Boston product joined a number of other DEBs already distributed in Europe for this indication, including Eurocor GMBH’s Freeway,Medtronic PLC’s IN.PACT, CR Bard Inc.’s Lutonix, and Cardionovum GMBH’s Legflow. Significantly, however, no DEB has so far been granted FDA approval for clinical use in the US, and the race is still on there to be first to market. (SeeAlso see "Drug-Coated Balloons Fuel Multibillion-Dollar Hopes" - Medtech Insight, 30 January, 2013.andAlso see "Re-Evaluating Growth Opportunities In Vascular Interventional Device Markets" - Medtech Insight, 28 February, 2014..)
According to the American Heart Association, approximately 8.5 million Americans are affected by PAD, with the highest prevalence occurring among elderly people, non-Hispanic blacks, and women. Medtronic puts the number...
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