Boston Scientific's TAXUS Stent System Receives FDA Approval for Extended Shelf Life

Strategic Insights -

Boston Scientific Corporation, a worldwide developer, manufacturer, and marketer of medical devices, 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. This decision was based on data submitted by Boston Scientific to the FDA, demonstrating the performance of the TAXUS system and its maintenance within FDA-approved specifications at twelve months. The new shelf life is longer than any competing product, providing an additional benefit to physicians and healthcare professionals.

Key Takeaways:

  • The FDA has approved extending the shelf life of Boston Scientific's TAXUS Express2 paclitaxel-eluting coronary stent system to twelve months in the United States.
  • The decision was based on data demonstrating the performance of the TAXUS system, including its drug content, degradation profile, and release mechanism, remained within FDA-approved specifications at twelve months.
  • The extended shelf life is longer than any competing product.
  • The new expiration date applies to all sizes of the TAXUS system for sale in the United States.
  • Boston Scientific will 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 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 used in interventional medical specialties.

Statistics:

  • The extended shelf life of the TAXUS Express2 stent system is twelve months.
  • The current shelf life of the TAXUS system in the United States is nine months.
  • The shelf life for the TAXUS system outside the United States is 18 months.
  • Portland Scientific's Chief Operating Officer, Paul LaViolette, stated, "The extended shelf life of TAXUS offers an additional benefit to physicians and other healthcare professionals making purchasing decisions for drug-eluting stents."
  • Boston Scientific's products are used in a broad range of interventional medical specialties.

Sources:

  • Boston Scientific Corporation. (May 23). Boston Scientific Receives FDA Approval for Extended Shelf Life of TAXUS(R) Express2(TM) Paclitaxel-Eluting Coronary Stent System. PRNewswire-FirstCall.
  • Boston Scientific Corporation. (https://www.bostonscientific.com/).