Large Animal Models in Cardiac and Vascular Biomaterials Research and Assessment

The purpose of using animal models in preclinical evaluation of biomaterials is to provide a preliminary assessment of human safety and efficacy relative to the manufacturer claims and comparable technology that can be used as an appropriate control standard. The development of new technologies, including in vitro methods and computer modeling, that has occurred in the last few decades has enhanced the approach to the study of physiology. However, the use of in vivo models still remains a necessity in investigations into certain physiologic phenomena, especially those related to the pathophysiologic mechanisms of disease, as in vitro studies are limited to the assessment of durability of the test material and hemodynamic performance. In this chapter, we will focus on three commonly used animal models for in vivo biomaterials research and testing in cardiac and vascular surgery: pigs; cows; and sheep. The chapter begins with current recommendations for in vivo preclinical evaluation of cardiac and vascular devices and continues with a short discussion on responsible use of animals in the assessment of biomaterials and biomedical devices, followed by specific considerations and examples of existing animal models for each species. Finally, we discuss conventionally-placed devices and percutaneously-placed devices, as well as potential future directions.

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