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Neurothrombectomy Devices for Acute Ischemic Stroke Treatment - Pre-clinical and Clinical Testing

This guidance outlines FDA's recommendations for pre-clinical and clinical studies for neurothrombectomy devices intended to retrieve or destroy blood clots in cerebral neurovasculature for ischemic stroke treatment. It covers mechanical (snare or suction), laser, ultrasound technologies, or combination of technologies.

  1. Determine appropriate regulatory pathway (510(k), de novo, or PMA)
  2. Conduct comprehensive biocompatibility testing
  3. Perform bench testing to evaluate device mechanical properties
  4. Complete animal studies to assess usability, safety and effectiveness
  5. Design and conduct clinical study with:
    • Clear inclusion/exclusion criteria
    • Appropriate control group
    • Comprehensive initial and follow-up assessments
    • Well-defined safety and effectiveness endpoints
  6. Document all adverse events and outcomes thoroughly
  7. Consider consulting with FDA’s General Surgery Devices Branch for study design
  8. Ensure independent review of imaging and clinical assessments
  9. Validate any surrogate endpoints used in the study

Key Considerations

Clinical testing

  • Subject selection criteria including inclusion/exclusion criteria
  • Treatment window within 8 hours of symptom onset
  • Initial assessments: angiography, imaging (CT/MRI), neurological evaluation (NIHSS)
  • Follow-up assessments at multiple timepoints up to 90 days
  • Primary endpoints for safety and effectiveness
  • Clinical outcomes using validated neurologic scales (mRS, NIHSS, Barthel Index)

Non-clinical testing

  • Bench testing to evaluate:
    • Maneuverability
    • Flexibility
    • Durability
    • Torque strength
  • Establish device failure endpoints

Biocompatibility

  • Testing according to ISO 10993-1 based on duration and level of contact
  • For 510(k), can reference predicate device if identical materials and processing

Safety

  • Evaluate hemorrhagic and thrombogenic potential
  • Monitor vessel wall integrity
  • Assess tissue damage potential
  • Monitor temperature changes for energy-emitting devices
  • Document all adverse events regardless of device relation
  • Categorize severity of adverse events

Other considerations

  • ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing

Original guidance

  • Neurothrombectomy Devices for Acute Ischemic Stroke Treatment - Pre-clinical and Clinical Testing
  • HTML / PDF
  • Issue date: 2007-06-18
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Good Clinical Practice (GCP)
  • ReguVirta summary file ID: eb35b0736b1171200edb915c68105ac4
This post is licensed under CC BY 4.0 by the author.