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Patel, S M1; Allaire, P E2; Wood, H C2; Throckmorton, A L1; Olsen, D B3

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Purpose: In over forty years of research, there are only three FDA approved artificial heart pumps available for clinical use. Reaching clinical approval in the United States requires years of extensive development and performance testing. This comprehensive study examines the methods of failure and reliability analysis applied to left ventricular assist devices (LVAD) and total artificial heart (TAH) pumps. Methods: As the only three pumps clinically approved for usage, the reliability and failure studies of the Baxter Healthcare Novacor N100PC, Thoratec Heartmate SNAP-VE, and Thoratec Heartmate XVE will be discussed in detail, based on available literature. Pumps in the design stages that will also he discussed include the AB-180 Abiocor TAH, American Biomed-Baylor TAH, Arrow Lionheart LVAS, Cleveland Clinic-Nimbus TAH, CorAide, DeBakey LVAD, Heartmate III, Hemadyne, Jarvik 2000, and Magscrew TAH. Pump reliability testing through modeling, mock loops, and animal testing will he reviewed. Results: Failure and reliability studies are a unique and innovative approach to design and safety improvements of artificial organs. While these methods are not well established, they are required for FDA approval of medical devices. This review paper is an introduction to currently applied analysis techniques and addresses the need and importance of failure and reliability.

Copyright © 2004 by the American Society for Artificial Internal Organs