Methodology for the Development and Validation of New Stent Designs: In Vitro and In Vivo Models

AbstractThe urinary tract is a highly complex, dynamic and variable environment that renders the development of urinary stents extremely challenging. It is mandatory that previous to clinical trials, innovations in urinary medical devices are tested in a preclinical context. The steps of translational research in this regard includein silico,in vitro,ex vivoandin vivoassessments. In this chapter, a critical review of the in vitro stent assessment models is performed, outlining briefly their strengths and weaknesses. Subsequently, a discussion concerning the available animal models for urinary stent evaluation is made with the aim of providing a critical guide for experimental preclinical evaluation of urological devices.