Boston Scientific Corp. (NYSE:BSX) has the first commercial implantations of Taxus Element in Europe under its belt, a month after winning CE Mark approval in the European Union.
The Natick, Mass.-based medical device maker said the first European use of the device occurred in Italy and the U.K. It’s the third iteration of the company’s Taxus paclitaxel-eluting platform, made of a platinum-chromium alloy using a new design.
The CE Mark, which BSX landed May 12, included an indication for the treatment of diabetes. The company said it expects to win 510(k) clearance from the Food & Drug Administration in mid-2011. Its Promus Element line, using the same stent platform but eluting the drug everolimus, won a CE Mark last October. Boston Scientific said it expects a nod from the FDA for that device in mid-2012.
In March BSX touted the results of a clinical trial of the Taxus Element, saying it showed that the platinum chromium paclitaxel-eluting device was about as safe and effective as its forebears.