Preclinical evaluation

Abstract

Mechanical circulatory and respiratory support systems are classified as high-risk devices that support or sustain human life by regulatory authorities worldwide and as such are required to undergo rigorous preclinical evaluation prior to adaption as treatment methods. This chapter discusses preclinical evaluation methods used to guide cardiac and respiratory assist device development, with different evaluation strategies (i.e., in silico, in vitro, and in vivo) described in depth. During in silico device evaluation, utilizing numerical simulations, potential devices and their interaction with a simulated cardiovascular system can be tested without having to build actual device prototypes or test set-ups. Actual device prototypes are then evaluated in vitro (e.g., in mock circulation loops, blood loops, or particle image velocimetry systems), which is necessary to comply with FDA regulations prior to in vivo trials. Following in silico and in vitro testing, devices are assessed in vivo utilizing large animal models, which are a critical component in the effort to translate device development into beneficial clinical practice. Only after successful preclinical evaluation can new devices undergo clinical trials and commercial distribution.