Boston Scientific Announces FDA Approval of TAXUS(R) Express2(TM) Atom(TM) Stent System, First Drug-Eluting Stent For Sma...( Company also announces FDA approval ...)

Company also announces FDA approval of TAXUS(R) Express2(TM) Stent System

for treatment of in-stent restenosis

NATICK, Mass., Sept. 25 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS(R) Express2(TM) Atom(TM) 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. It is the only DES approved by the FDA for use in vessels as small as 2.25 mm in diameter. No other DES for sale in the U.S. market is approved for use in vessels smaller than 2.50 mm in diameter. The Company plans to launch the product immediately.

The Company today also announced FDA approval of its TAXUS(R) Express2(TM) 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 United States for the treatment of in-stent restenosis in bare-metal stents.

"The TAXUS Express Atom Stent will provide better options for U.S. patients with coronary artery disease in small vessels," said Gregg Stone, M.D., 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
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