Boston Scientific Corporation has announced that the FDA has approved extending the shelf life of its Taxus Express2 paclitaxel-eluting coronary stent system in the U.S. to 18 months from its current shelf life of 12 months.
The decision was based on data showing that the stent’s performance—its drug content, drug-degradation profile, and system of drug release—was maintained within the FDA’s specifications at 18 months. The new shelf life is longer than that for other drug-eluting stents.
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The extended expiration date applies to all available sizes of the stent for sale in the U.S. The shelf life for the Taxus stent outside the U.S. is still 18 months.