Preclinical Assessment of Cardiac Valve Substitutes: Current Status and Considerations for Engineered Tissue Heart Valves

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  Figure 1. Roadmap of development to clinical use of TEHV, highlighting the pre-clinical study phase emphasized in this review (red box): Initial concept design followed by in vitro testing and in vivo animal studies, with potentially iterative preclinical testing and redesign steps as indicated (e.g., materials, design, animal model, etc.). Once a final design is reached, in vivo animal testing is conducted in the high quality Good Laboratory Practice (GLP) phase for submission to regulatory authorities, i.e., the FDA or European Notified Body for approval for clinical studies. Following this limited “first in human” study, “pivotal” clinical studies should commence with careful long term followup. If pivotal studies demonstrate satisfactory safety, performance and potential efficacy, the end product typically gains approval for marketing.