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news.Boston Scientific, a developer, manufacturer and marketer of medical devices, has received approval from the FDA to market its Taxus Express2 Atom paclitaxel-eluting coronary stent system.
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According to the company, the Taxus Express Atom stent is a highly deliverable drug-eluting stent (DES) specifically designed for treating small coronary vessels. It is the only DES approved by the FDA for use in vessels as small as 2.25mm in diameter. The company plans to launch the product immediately.
The company also announced the FDA approval of its Taxus Express2 paclitaxel-eluting coronary stent system for the treatment of in-stent restenosis in bare-metal stents. This is the first such approval granted by the FDA, making the Taxus Express2 stent system the only drug-eluting stent approved in the US for the treatment of in-stent restenosis in bare-metal stents, the company said.
Jim Tobin, president and CEO of Boston Scientific, said: “With the recent FDA approval of our Promus stent and now the Taxus Express Atom stent for small vessels, Boston Scientific offers the most comprehensive DES portfolio in the industry, offering physicians and their patients the broadest size matrix and the industry’s only two-drug platform.”