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Taxus Express Atom Stent receives US FDA approval

Boston Scientific : 25 September, 2008  (New Product)
Boston Scientific has received approval from the US FDA to market its Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System.
The Taxus Express Atom Stent is a highly deliverable drug-eluting Stent (DES) specifically designed for treating small coronary vessels. The Stent is the only DES approved by the FDA for use in vessels as small as 2.25mm in diameter. No other DES for sale in the US market is approved for use in vessels smaller than 2.50mm in diameter. The Company plans to launch the product immediately.

The company has also announced 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 USA for the treatment of in-stent restenosis in bare-metal stents.

'The Taxus Express Atom Stent will provide better options for US patients with coronary artery disease in small vessels,' said Gregg Stone, MD, chairman of the Cardiovascular Research Foundation and professor of medicine at Columbia University Medical Center, and principal investigator of the Taxus IV and V clinical trials. 'This is a welcome addition to the range of available drug-eluting stents, since patients with small vessels who are currently treated with bare-metal stents experience high rates of restenosis. In the Taxus V clinical trial, the Taxus Express Atom Stent significantly reduced the chance of restenosis and the need for repeat procedures compared to bare-metal stents, in patients with small vessel disease.'

'Our Taxus Express Atom Stent addresses an unmet need and will help interventional cardiologists better treat small vessel disease,' said Jim Tobin, president and chief executive officer of Boston Scientific. '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.'

'In addition to being a welcome product approval, we believe this is also an important indication we have made significant progress toward resolving the issues related to the Corporate Warning Letter,' added Tobin.

Taxus stents have been evaluated by the industry's most extensive randomized, controlled clinical trial programme, with follow-up to five years in some cases. These trial results have been supplemented by data on more than 35,000 patients enrolled in post-approval registries. To date, approximately 4.6 million Taxus stents have been implanted globally, making them the world's most frequently used drug-eluting stents.
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