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Medical equipment industry

Boston Scientific Receives FDA Approval for Cutting Balloon Device Distribution and Manufacturing

Strategic Insights

— 2 min read

Boston Scientific Corporation announced that the U.S. Food and Drug Administration (FDA) has approved its Quincy Distribution Center as a sterilization site for the Cutting Balloon microsurgical dilatation device product line. Additionally, 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. This approval will enable Boston Scientific to deliver the Cutting Balloon technology to more clinicians efficiently, with in-house sterilization in Quincy and expanded manufacturing in Letterkenny improving operational efficiency and reducing delivery time to customers and patients.

Key Takeaways:

  • The Quincy Distribution Center has been approved as a sterilization site for the Cutting Balloon product line using electron-beam ("e-beam") technology.
  • The 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 Cutting Balloon Ultra2 device features a novel mechanism that safely dilates coronary lesions at lower pressures, using tiny, longitudinally mounted atherotomes (microsurgical blades) to relieve stress in the artery.
  • The Peripheral Cutting Balloon device uses the same mechanism of action as the Cutting Balloon Ultra2, but in a larger size (2 cm length and diameters up to 8 mm) for treating synthetic grafts of patients with End Stage Renal Disease (ESRD).
  • Boston Scientific plans to use the Quincy Distribution Center to sterilize other devices in its product portfolio in the future.
  • The company received no adverse observations from the FDA following quality systems inspections at its facilities in California, Quincy, and Letterkenny.
  • Paul LaViolette, Boston Scientific Chief Operating Officer, stated that the FDA approvals will enable the company to increase production, improve operational efficiency, and decrease delivery time to the customer and ultimately, the patient.

Statistics:

  • 3 facilities (Quincy, California, and Letterkenny) received quality systems inspections from the FDA, with no adverse observations.
  • 2 versions of the Cutting Balloon product line have been approved for distribution in the United States market (Cutting Balloon Ultra2 and 2cm Peripheral Cutting Balloon).
  • 2 cm is the length of the Peripheral Cutting Balloon device.
  • 8 mm is the diameter of the Peripheral Cutting Balloon device.
  • 10% is the rate at which kidneys must be functioning to be considered normal, compared to ESRD patients who have impaired or functioning kidneys at less than 10%.

Sources:

  • Natick, Mass., March 15 /PRNewswire-FirstCall/
  • Boston Scientific Corporation press release
  • U.S. Food and Drug Administration (FDA) approval
  • Boston Scientific Corporation website: http://www.bostonscientific.com/

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