Tags: Boston Scientific, Boston Scientific Corporation, FDA, Healthcare Plan News, Stent System
FDA Approves 18-Month Shelf Life for TAXUS Stent System by Boston Scientific Corporation
Boston Scientific Corporation (NYSE:BSX) has recently announced that the U.S. Food and Drug Administration (FDA) has approved extending the shelf life of its TAXUS(R) Express(2)(TM) paclitaxel-eluting coronary stent system in the United States to 18 months from the current shelf life of 12 months. The decision was based on data submitted by Boston Scientific to the FDA that demonstrated the performance of the TAXUS Stent — in particular the drug content, drug degradation profile and drug-release — was maintained within FDA-approved specifications at 18 months. The newly approved TAXUS Stent U.S. shelf life is longer than any competing drug-eluting stent product.
The extended expiration date applies to all available sizes of the TAXUS Stent for sale in the United States. The Company said it would immediately begin updating labels to reflect the 18-month expiration date. The shelf life for the TAXUS Stent outside the United States remains unchanged at 18 months.
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: www.bostonscientific.com.
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