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Medical equipment industry

FDA Approves Extended Shelf Life for Boston Scientific's TAXUS Express2 Stent System

Strategic Insights

— 1 min read

Boston Scientific's TAXUS Express2 paclitaxel-eluting coronary stent system has been granted a three-month extension by the U.S. Food and Drug Administration (FDA), allowing the stent to be stored for nine months from the current six-month shelf life. This decision was made after Boston Scientific submitted data demonstrating the system's performance, including drug content, degradation profile, and drug-release mechanism, remained within FDA-approved specifications at the new expiration date. The updated shelf life applies to all sizes of the TAXUS system sold in the United States, with the company immediately beginning label updates. Outside the U.S., the shelf life remains unchanged at 18 months.

Key Takeaways:

  • The FDA has approved a three-month extension of the shelf life of Boston Scientific's TAXUS Express2 paclitaxel-eluting coronary stent system in the United States, increasing the shelf life to nine months.
  • The decision was based on data submitted by Boston Scientific demonstrating the system's performance was maintained within FDA-approved specifications at nine months.
  • The extended 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 nine-month expiration date.
  • The shelf life for the TAXUS system outside the United States remains unchanged at 18 months.
  • The decision was made after the company submitted performance data to the FDA.
  • The company is a worldwide developer, manufacturer, and marketer of medical devices used in various interventional medical specialties.
  • The news comes as Boston Scientific continues to develop and commercialize new technologies in the medical device industry.

Statistics:

  • Shelf life of TAXUS Express2 stent system in the United States increased by 3 months.
  • Shelf life of TAXUS Express2 stent system in the United States now equals 171 days (9 months).
  • Shelf life of TAXUS system outside the United States remains unchanged at 18 months (540 days).
  • 100% of TAXUS system sizes sold in the United States will have the updated expiration date.
  • The company's products are used in various interventional medical specialties.

Sources:

  • Boston Scientific Corporation. (n.d.). Boston Scientific Announces FDA Approval to Extend Shelf Life of TAXUS Express2 Paclitaxel-Eluting Coronary Stent System to 9 Months. Retrieved from http://investor.bostonscientific.com.
  • U.S. Food and Drug Administration. (n.d.). FDA Approvals. Retrieved from https://www.fda.gov/regulatory-information/sunshine-act/fda-approvals.

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