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Medical equipment industry

Boston Scientific Announces FLAME Clinical Trial for Embolic Protection During PCI

Strategic Insights

— 1 min read

Boston Scientific Corporation (BSX) has initiated enrollment in the FLAME clinical trial, a prospective, multicenter, randomized study designed to evaluate the benefits of filter-based embolic protection during primary percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI). The trial will involve approximately 500 patients at up to 60 sites in the U.S. and 20 sites internationally, assessing the effectiveness of the FilterWire EZ Embolic Protection System in preventing embolization during PCI.

Key Takeaways:

  • The FLAME trial will evaluate the use of two sizes of the Boston Scientific FilterWire EZ Embolic Protection System in patients undergoing primary PCI for AMI.
  • Approximately one-half of the patients will be randomized to the FilterWire EZ System with aspiration, while the other half will receive primary PCI without embolic protection.
  • The trial aims to demonstrate that the use of the FilterWire EZ Embolic Protection System during primary PCI for AMI significantly improves patient outcomes.
  • Embolization has been shown to complicate approximately 15% of primary PCIs and is associated with an adverse outcome.
  • The FilterWire EZ System captures embolic material that becomes dislodged during interventions, preventing it from traveling into the microvasculature.
  • The filter is designed to reduce complications during balloon angioplasty and stenting procedures.
  • The FilterWire EZ System in the 3.5-5.5 mm vessel diameter size is pending 510(k) clearance from the FDA to treat saphenous vein graft (SVG) disease.

Statistics:

  • The FLAME trial will enroll approximately 500 patients at up to 60 sites in the U.S. and 20 sites internationally.
  • Approximately one-half of the patients will be randomized to the FilterWire EZ System with aspiration, while the other half will receive primary PCI without embolic protection.
  • Embolization is associated with an adverse outcome in approximately 15% of primary PCIs.

Sources:

  • Boston Scientific Corporation (BSX)
  • NewsRx.com
  • NewsRx.net
  • Biotech Business Week editors from staff and other reports

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