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TAXUS™ Express2™
Paclitaxel-Eluting Coronary Stent System
Recently, we received approval from the U.S. Food and Drug Administration
(FDA) to market our TAXUS Express2 paclitaxel-eluting coronary stent
system in the United States. We have been working toward this moment
for a long time, and our manufacturing, distribution, sales and
marketing teams are fully mobilized to make this revolutionary new
treatment for coronary artery disease available to patients throughout
the country.
This significant milestone was the culmination of
a remarkable series of accomplishments over the past year. Early
in 2003, we launched the TAXUS system in Europe and other international
markets, and we quickly achieved market share leadership in those
markets. In September, we released outstanding data from TAXUS IV,
our pivotal U.S. clinical trial, supporting the safety and efficacy
of the TAXUS system for reducing restenosis. In November, an FDA
advisory panel unanimously recommended that the FDA approve the
TAXUS system, and in early 2004 we received flawless reports from
the FDA teams inspecting our TAXUS system manufacturing facilities
in Galway, Ireland and Maple Grove, Minnesota.
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