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Medical equipment industry

Boston Scientific Receives FDA Approval for Sterilization and Manufacturing Facilities

Strategic Insights

— 1 min read

Boston Scientific Corporation (BSX) has obtained approval from the U.S. Food and Drug Administration (FDA) for its Quincy Distribution Center as a sterilization site for its Cutting Balloon microsurgical dilatation device product line. The company's Letterkenny, Ireland facility has also received FDA approval to manufacture two versions of the Cutting Balloon product line for distribution in the United States market. The approvals allow for increased production, improved operational efficiency, and faster time-to-market for the Cutting Balloon technology.

Key Takeaways:

  • The Quincy Distribution Center has been approved as a sterilization site for Boston Scientific's Cutting Balloon device product line using electron-beam ("e-beam") technology.
  • The company's Letterkenny, Ireland facility has received FDA approval to manufacture two versions of the Cutting Balloon product line for distribution in the United States market.
  • The approvals followed quality systems inspections at Boston Scientific facilities in California, Quincy, and Letterkenny, with no adverse observations from the FDA.
  • Paul LaViolette, Boston Scientific chief operating officer, stated that the approvals will enable the company to deliver the Cutting Balloon technology to more clinicians more efficiently.
  • The Letterkenny facility will manufacture the Cutting Balloon Ultra2 device and the 2cm Peripheral Cutting Balloon device for distribution in the U.S. market.
  • The Cutting Balloon Ultra2 device features a novel mechanism for dilating coronary lesions at lower pressures using tiny, longitudinally mounted atherotomes (microsurgical blades).
  • The Peripheral Cutting Balloon device will be used to treat synthetic grafts of patients undergoing hemodialysis for End Stage Renal Disease (ESRD).

Statistics:

  • The Cutting Balloon Ultra2 device has been designed for the treatment of coronary artery disease with a novel mechanism that dilates coronary lesions at lower pressures.
  • The Peripheral Cutting Balloon device is 2cm in length and diameter up to 8mm, and will be used to treat synthetic grafts of patients undergoing hemodialysis for ESRD.
  • According to the company, the approvals will enable the delivery of the Cutting Balloon technology to more clinicians more efficiently and improve operational efficiency.

Sources:

  • Health & Medicine Week editors from staff and other reports
  • NewsRx.com

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