Boston Scientific Corp.’s (NYSE:BSX) third-generation stent platform, the platinum-chromium Omega bare-metal stent, won CE Mark approval in the European Union.
Boston Scientific said it plans to make the device available "immediately" in the EU and other countries that recognize the mark. It’s the first of a trio of stents the Natick, Mass.-based medical device maker plans to launch on the platform, according to a press release.
BSX also makes a Taxus version of the stent that release the drug paclitaxel and an everolimus-eluting Promus-brand version. Should it win favor at the FDA, it’s destined for the U.S. market under the Ion (paclitaxel) and Promus (everolimus) brands.
The company said it anticipates Food & Drug Administration approval for the Ion system in mid-2011 and mid-2012 approval for the Promus system. Across the pond, CE Mark approval for the Promus version is expected during the second half of this year, with Japanese approval for the Taxus version coming "in late 2011 or early 2012, and mid-2012" for the Promus version.
Boston Scientific is battling to win back more of the coronary stent market from other major players, including Abbott (NYSE:ABT) and its leading Xience V stent and Johnson & Johnson’s (NYSE:JNJ) Cordis Corp. CEO Ray Elliott is looking at 2011 as a re-building year "to set the table for 2012."