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The Biocompatibility and Biostability of New Cardiovascular Materials and Devices

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Implantable Neural Prostheses 2

Part of the book series: Biological and Medical Physics, Biomedical Engineering ((BIOMEDICAL))

Abstract

Evaluating a new material for use in an implantable device is a complicated business. ISO 14971 is designed to assist in determining device-risk assessment. ISO 10993 is intended to help steer one through the evaluation of materials for implantable devices. An FDA Guidance is available specifically for pacemaker leads, but may be helpful for other devices as well. However, completing a battery of in vitro and in vivo tests does not necessarily qualify a material for implant, because the in vivo environment cannot be duplicated in vitro. In vivo materials testing helps, but is still insufficient because the device may have its own issues. Device implants in animals may get one to human clinical studies and market release. Even after this stage, appropriate postmarket surveillance is necessary to know for sure how the device is really performing.

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Notes

  1. 1.

    Initially Upjohn, later Dow Chemical, Midland Michigan.

  2. 2.

    Dupont

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Author information

Authors and Affiliations

  1. Brady Leads Research, Cardiac Rhythm Disease Management Division, Medtronic, Inc., 56401-5947, 11052 Robinwood Lane, Brainerd, MN, USA

    Ken Stokes

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  1. Ken Stokes
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Correspondence to Ken Stokes .

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Editors and Affiliations

  1. Second Sight Medical Products, Inc., San Fernando Road 12744, Sylmar, 91342, USA

    David Zhou

  2. Oak Ridge National Laboratory, Oak Ridge, USA

    Elias Greenbaum

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Stokes, K. (2009). The Biocompatibility and Biostability of New Cardiovascular Materials and Devices. In: Zhou, D., Greenbaum, E. (eds) Implantable Neural Prostheses 2. Biological and Medical Physics, Biomedical Engineering. Springer, New York, NY. https://doi.org/10.1007/978-0-387-98120-8_1

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  • DOI: https://doi.org/10.1007/978-0-387-98120-8_1

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  • Publisher Name: Springer, New York, NY

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  • Online ISBN: 978-0-387-98120-8

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