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Ten-year experience with implanted polyurethane lead insulation.

K B Stokes, T Church

    Pacing and Clinical Electrophysiology : PACE
    |November 1, 1986
    PubMed
    Summary
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    Newer polyurethane leads show excellent performance after manufacturing changes in 1981. Reliable data and accelerated testing now ensure confidence in long-term polyurethane lead technology.

    Area of Science:

    • Biomaterials science
    • Medical device engineering

    Background:

    • Polyurethane leads have been used in human implants since 1977.
    • Manufacturing process modifications were implemented in 1981 following reports of stress cracking.

    Purpose of the Study:

    • To assess the long-term performance and reliability of polyurethane leads.
    • To address concerns regarding the accurate prediction of lead longevity.

    Main Methods:

    • Analysis of historical implantation data since 1977.
    • Review of manufacturing process changes implemented in 1981.
    • Utilization of accelerated testing methods predictive of human performance.
    • Evaluation of statistically accurate actuarial data.

    Main Results:

    Related Experiment Videos

    • Initial polyurethane leads experienced stress cracking issues reported in 1981.
    • Post-1981 manufacturing changes resulted in excellent subsequent performance.
    • Current data and testing methods provide reliable predictions for long-term performance.

    Conclusions:

    • The evolution of polyurethane lead technology demonstrates a successful response to early performance concerns.
    • The combination of actuarial data and accelerated testing restores confidence in the long-term reliability of modern polyurethane leads.