Volume 3, Issue 6 (June 2006)

    FDA Recommendations for Nitinol Stent and Endovascular Graft Fatigue Characterization and Fracture Reporting

    (Received 9 November 2005; accepted 11 March 2006)

    Published Online: 2006

    CODEN: JAIOAD

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    Abstract

    Intravascular stents and endovascular stent-grafts provide a minimally invasive option for treating vascular disease and injury. Medical device manufacturers typically conduct radial pulsatile fatigue testing of intravascular stents and endovascular grafts to demonstrate that these devices will maintain their durability for ten years of implant life. While they are useful indicators of device performance, these test regimens do not always predict device durability in the clinical setting with perfect accuracy. In this paper, we address some of the common issues that should be considered in the design of fatigue tests, including appropriate sample sizes for fatigue testing, sample selection, loading conditions, and test setup issues. We also discuss finite element analysis of long-term cyclic fatigue. In addition, we describe appropriate methods for reporting the incidence of stent fractures after implantation. Our goals are to assist manufacturers and test laboratories in refining their in vitro fatigue testing methods to allow more accurate prediction of clinical device fractures, and to maximize the amount of useful data contained in clinical fracture reports.


    Author Information:

    Cavanaugh, KJ
    Biomedical Engineers, Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, MD

    Holt, VM
    Mechanical Engineer, Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, MD

    Goode, JL
    Biomedical Engineers, Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, MD

    Anderson, E
    Medical Device Fellowship Program Participant, Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, MD20850. Current affiliation: Research Engineer, Guidant Corporation, Santa Clara, CA


    Stock #: JAI100384

    ISSN: 1546-962X

    DOI: 10.1520/JAI100384

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    Author
    Title FDA Recommendations for Nitinol Stent and Endovascular Graft Fatigue Characterization and Fracture Reporting
    Symposium Fatigue and Fracture of Medical Metallic Materials and Devices, 2005-11-11
    Committee E08