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Related Experiment Videos

Marketing approval for the lithotripter.

S L Nightingale, F E Young

    Israel Journal of Medical Sciences
    |July 1, 1986
    PubMed
    Summary

    The Food and Drug Administration approved the external shock wave lithotripter (ESWL) for marketing in the USA after rigorous safety and effectiveness evaluations. This non-invasive treatment offered an alternative to surgical procedures for kidney stones.

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    From the Food and Drug Administration.

    JAMA·1999

    Area of Science:

    • Medical Devices
    • Nephrology
    • Surgical Innovation

    Background:

    • The Food and Drug Administration (FDA) regulates medical devices to ensure safety and effectiveness.
    • The Medical Device Amendments mandate comprehensive evaluations for commercial distribution in the U.S.

    Purpose of the Study:

    • To evaluate the safety and effectiveness of the external shock wave lithotripter (ESWL) for marketing approval.
    • To assess ESWL as an alternative to traditional surgical procedures for nephrolithiasis.

    Main Methods:

    • Pre-clinical studies: in vitro stone destruction, animal testing (rats, dogs).
    • Investigational Device Exemption (IDE) process, including Institutional Review Board approval.
    • Clinical trials in West Germany (667 patients) and U.S. facilities (327 patients).
    • Submission of comprehensive data (in vitro, animal, human) for Premarked Approval Application (PMAA).

    Main Results:

    • Dornier Systems (FRG) received FDA marketing approval for the ESWL in December 1984.
    • Extensive data demonstrated the feasibility and safety of the ESWL technique.
    • The FDA considered ESWL alongside alternative treatments like percutaneous nephrolithotomy and open surgery.

    Conclusions:

    • The ESWL was deemed safe and effective for treating kidney stones.
    • Marketing approval was granted following a thorough review of scientific, animal, and human data.
    • Discussions on device labeling and postmarketing surveillance were completed prior to approval.

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