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FDA Approves 12-Month Shelf Life
for Taxus® Stent System New U.S. shelf life is longer than any competing product NATICK, Mass., May 23 -- Boston Scientific Corporation (NYSE: BSX - News) today announced that the U.S. Food and Drug Administration (FDA) has approved extending the shelf life of its TAXUS® Express2™ 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: http://www.bostonscientific.com. 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 Source: Boston Scientific Corporation |
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