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Medical equipment industry

Boston Scientific Receives FDA Approval for Wingspan Stent System

Strategic Insights

— 1 min read

Boston Scientific Corporation (BSX) has announced the U.S. Food and Drug Administration (FDA) approval for the Wingspan Stent System with Gateway PTA Balloon Catheter, a device designed to treat atherosclerotic lesions in brain arteries. The Wingspan Stent System is the only device available in the U.S. for treating intracranial atherosclerotic disease (ICAD), and is indicated for improving cerebral artery lumen diameter in patients with ICAD who are unresponsive to medical therapy. The FDA granted approval based on a 45-patient Wingspan HDE Safety Study, which demonstrated a 100% stent success rate and a 4.4% incidence of death or stroke at 30 days post-procedure. Boston Scientific plans to launch the device to select centers and is currently in discussion with the Centers for Medicare and Medicaid Services about obtaining Medicare coverage and reimbursement.

Key Takeaways:

  • The Wingspan Stent System is designed to treat atherosclerotic lesions in brain arteries and is the only device available in the U.S. for treating intracranial atherosclerotic disease (ICAD).
  • The FDA granted approval based on a 45-patient Wingspan HDE Safety Study, which demonstrated a 100% stent success rate and a 4.4% incidence of death or stroke at 30 days post-procedure.
  • The incidence of death or same hemisphere stroke at 6-month follow-up was 7.0%.
  • Boston Scientific plans to launch the device to select centers that have extensive experience in the endovascular treatment of ICAD.
  • The company is currently in discussion with the Centers for Medicare and Medicaid Services about obtaining Medicare coverage and reimbursement for ICAD procedures that use the Wingspan Stent System.
  • Additional studies will be conducted to evaluate the Wingspan Stent System's performance after launch.
  • Ischemic stroke is caused by a blocked blood vessel that obstructs blood flow and deprives the brain of oxygen, which can lead to death or disability.

Statistics:

  • 45-patient Wingspan HDE Safety Study was conducted at 12 sites in Europe and Asia.
  • 100% stent success rate was achieved in the study.
  • 97.7% procedural success rate was achieved in the study.
  • 4.4% incidence of death or stroke in the same hemisphere of the brain as the lesion at 30 days post-procedure.
  • 7.0% incidence of death or same hemisphere stroke at 6-month follow-up.

Sources:

  • Boston Scientific Corporation (BSX) press release
  • U.S. Food and Drug Administration (FDA) approval letter
  • Biotech Business Week via NewsRx.com, 2005.

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