Boston Scientific stent approved for longer shelf life
Natick-based Boston Scientific Corp. has received approval from the U.S. Food and Drug Administration (FDA) for extending the shelf life of its TAXUS Express(2) paclitaxel-eluting coronary stent system to 18 months from its current shelf life of 12 months.
The decision was reached after Boston Scientific submitted data to the FDA showing that the TAXUS stent - specifically, the drug content, drug degradation profile and drug-release - was maintained within FDA-approved specifications at 18 months. The upgraded shelf life is longer than any other competing drug-eluting stent product.
Boston Scientific plans to immediately adjust all labels to reflect the longer expiration date. Outside of the U.S., the expiration date for the TAXUS stent remains unchanged at 18 months.
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