Non-Clinical Testing and Labeling Requirements for Extracranial Intravascular Stents and Delivery Systems
This guidance addresses self-expanding and balloon expandable extracranial intravascular stents and their associated delivery systems used in coronary or peripheral arteries and saphenous vein grafts. It excludes intracranial stents, non-vascular stents, and provides limited guidance for covered, drug-eluting and biodegradable stents.
Recommended Actions
- Develop comprehensive test plan covering all required non-clinical testing categories
- Establish test protocols with clear acceptance criteria before conducting tests
- Perform material characterization and biocompatibility testing early in development
- Conduct accelerated durability testing to support IDE application (1-year equivalent) and complete 10-year equivalent testing for PMA
- Prepare detailed test reports including protocols, results, and data analysis
- Document MRI safety testing and develop appropriate labeling
- Develop comprehensive labeling including all required sections
- Consider additional testing requirements if targeting in-stent restenosis or bifurcation lesions
- Establish shelf life testing protocol and initiate real-time aging studies
- Prepare test summary checklist documenting all completed testing
Key Considerations
Non-clinical testing
- Material characterization (composition, shape memory properties, corrosion resistance)
- Dimensional verification and functional attributes (surface area, foreshortening, recoil, integrity)
- Radial strength and stiffness testing
- Stress/strain and fatigue analysis
- Accelerated durability testing
- Particulate evaluation
- Crush and kink resistance (peripheral stents only)
Labeling
- Device description including dimensions and specifications
- Indications for use
- Contraindications, warnings and precautions
- MRI safety information
- Clinical studies overview
- Adverse events reporting
- Directions for use
- Patient materials
Biocompatibility
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Hemocompatibility
- Pyrogenicity
- Additional testing based on materials used
Safety
- MRI safety and compatibility testing
- Shelf life testing
- Delivery system safety testing
- Stent securement testing
Other considerations
- Additional testing for in-stent restenosis use
- Additional testing for bifurcation lesions
- Coating integrity testing if applicable
Relevant Guidances
- Corrosion Testing and Surface Characterization Requirements for Intravascular Stents
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
Related references and norms
- ISO 10993: Biological Evaluation of Medical Devices
- ASTM F138: Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
- ASTM F2004: Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
- ASTM F2079: Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon expandable Stents
- ASTM F2081: Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
- ASTM F2129: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements
- ASTM F2394: Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
- IEC 60601-2-33: Medical electrical equipment – Part 2-33: Particular requirements for MRI equipment
Original guidance
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