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Heart Valves pp 283–320Cite as

In Vitro Testing of Heart Valve Substitutes

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Abstract

This chapter summarizes in vitro test methods for qualifying the design and manufacture of a heart valve substitute. The tests discussed herein are not intended to represent an exhaustive treatise of all potential in vitro heart valve tests, but rather to highlight those tests intended to characterize the primary functions and performance parameters of a heart valve substitute. The test methods focus primarily on the implantable device; however, there are many additional in vitro test methods beyond those described that are applicable to the implantable device (e.g., biocompatibility, MRI compatibility) as well as to other elements of a heart valve system. Specification of the comprehensive set of appropriate qualification tests and methods for a device under evaluation are to be derived from the risk assessment for the given device with consideration to the target patient population, valve implant position, and device design. The results from the in vitro testing effort provide a substantial and critical part of the regulatory submission package for the device prior to clinical implantation [1].

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Abbreviations

ε/N:

Strain/life

AWT:

Accelerated wear test

bpm:

Beats per minute

COF:

Chronic outward force

CT:

Computed tomography

DTA:

Damage tolerance analysis

EOA:

Effective orifice area

FCG:

Fatigue crack growth

FDA:

Food and Drug Administration

FEA:

Finite element analysis

IFU:

Instructions for use

ISO:

International Organization for Standardization

MDCT:

Multi-detector computed tomography

RRF:

Radial resistive force

S/N:

Stress/life

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Author information

Authors and Affiliations

  1. Medtronic, Inc., 8200 Coral Sea Street NE, M/S MVS84, Mounds View, MN, 55112, USA

    Timothy A. Kelley MS

  2. Edwards Lifesciences, One Edwards Way, Irvine, CA, 92614, USA

    Sal Marquez BS, MBA

  3. Southwest Research Institute, 6220 Culebra Road, San Antonio, TX, 78228-0510, USA

    Carl F. Popelar PhD

Authors
  1. Timothy A. Kelley MS
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  2. Sal Marquez BS, MBA
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  3. Carl F. Popelar PhD
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Corresponding author

Correspondence to Timothy A. Kelley MS .

Editor information

Editors and Affiliations

  1. , Mail Code 195, University of Minnesota, Delaware St. SE., 420, MINNEAPOLIS, 55455, Minnesota, USA

    Paul A. Iaizzo

  2. University of Minnesota, DELAWARE ST SE MMC 195 420, MINNEAPOLIS, 55455, Minnesota, USA

    Richard W. Bianco

  3. University of Minnesota, Department of Surgery, Medtronic, Inc., N/A, Minneapolis, 55432, Minnesota, USA

    Alexander J. Hill

  4. University of Minnesota, N/A, Minneapolis, 55455, Minnesota, USA

    James D. St. Louis

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Kelley, T.A., Marquez, S., Popelar, C.F. (2013). In Vitro Testing of Heart Valve Substitutes. In: Iaizzo, P., Bianco, R., Hill, A., St. Louis, J. (eds) Heart Valves. Springer, Boston, MA. https://doi.org/10.1007/978-1-4614-6144-9_12

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