Boston Scientific
Corporation (NYSE: BSX) announces that the US Food and Drug
Administration (FDA) has approved extending the shelf life of its TAXUS(R)
Express2(TM) paclitaxel-eluting coronary stent system in the United States to
twelve months from the current shelf life of nine months. The decision was
based on data submitted by Boston Scientific to the FDA that demonstrated the
performance of the TAXUS system -- in particular the drug content, drug
degradation profile and drug-release mechanism -- was maintained within
FDA-approved specifications at twelve months. The new TAXUS U.S. shelf life
is longer than any competing product.
The extended expiration date applies to all sizes of the TAXUS system for
sale in the United States. The Company said it would immediately begin
updating labels to reflect the twelve-month expiration date. The shelf life
for the TAXUS system outside the United States remains unchanged at 18 months.
"The extended shelf life of TAXUS offers an additional benefit to
physicians and other healthcare professionals making purchasing decisions for
drug-eluting stents," said Paul LaViolette, Chief Operating Officer of Boston
Scientific. "The extended shelf life may facilitate inventory management for
hospitals concerned with issues of stock rotation or product expiration."
Boston Scientific is a worldwide developer, manufacturer and marketer of
medical devices whose products are used in a broad range of interventional
medical specialties. For more information, please visit:
bostonscientific.
This press release contains forward-looking statements. Boston Scientific
wishes to caution the reader of this press release that actual results may
differ from those discussed in the forward-looking statements and may be
adversely affected by, among other things, risks associated with new product
development and commercialization, clinical trials, intellectual property,
regulatory approvals, competitive offerings, integration of acquired
companies, Boston Scientific's overall business strategy, and other factors
described in Boston Scientific's filings with the Securities and Exchange
Commission.
CONTACT:
Milan Kofol
508-650-8569
Investor Relations
Boston Scientific Corporation
Paul Donovan
508-650-8541 (Office)
508-667-5165 (Mobile)
Media Relations
Boston Scientific Corporation
Boston Scientific Corporation
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