STP1481

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

    Published: Jan 2007


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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.

    Keywords:

    medical device, stent, stent-graft


    Author Information:

    Cavanaugh, Kenneth J.
    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, Vivianne M.
    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, Jennifer L.
    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, Evan
    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, MD


    Paper ID: STP45244S

    Committee/Subcommittee: E08.93

    DOI: 10.1520/STP45244S


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