Devices & Diagnostics

Boston Scientific coronary stent approved for Europe

Boston Scientific Corp.’s (NYSE:BSX) third-generation coronary stent, the Taxus Element, is set to hit the market in Europe next month. The Natick, Mass.-based medical device giant said the latest version of its paclitaxel-eluting stent, made of a platinum-chromium alloy, won CE Mark approval in the European Union. The approval includes an indication for treatment of […]

Boston Scientific Corp.’s (NYSE:BSX) third-generation coronary stent, the Taxus Element, is set to hit the market in Europe next month.

The Natick, Mass.-based medical device giant said the latest version of its paclitaxel-eluting stent, made of a platinum-chromium alloy, won CE Mark approval in the European Union. The approval includes an indication for treatment of diabetics, according to a press release.

The début will come a little later than planned. Last March, then-CEO James Tobin told analysts at an investor’s conference that the Taxus Element was slated for European launch in October 2009.

The company is likely hoping that the latest Taxus model to hit the market can hold its own as it it tries to increase market share for its Promus line, which uses a different anti-restenosis compound called everolimus. A series of studies released by competitors Medtronic Inc. (NYSE:MDT), Johnson & Johnson’s (NYSE:JNJ) Cordis Corp. subsidiary and Abbott (NYSE:ABT) all claimed that their respective devices and the drugs they elute are superior to BSX’s paclitaxel-eluting line.

Recent results from Boston Scientific’s Perseus clinical trial of the Taxus element showed that it’s about as safe and effective as its forebears. The company is also running a 1,500-patient trial of the Promus Element, which is also made of the platinum-chromium alloy. That stent won CE Mark approval last October.

U.S. clearance from the Food & Drug Administration for the Taxus Element is expected in mid-2011, the company said. The FDA is expected to clear the Promus Element in mid-2012, according to a press release. Japanese clearance for the devices are expected in late 2011 or early 2012 and mid-2012, respectively, according to the release.

Boston Scientific also said it won FDA approval for a software upgrade to its Latitude patient management system, which allows doctors to remotely monitor patients with implantable cardiac devices.

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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