ABSTRACT

Bench testing provides an understanding of the mechanical properties of different scaffolds and aids the interventionalist in device selection. It provides insights on how devices work, their strengths and weaknesses, and can test efficacy of design iterations and procedural changes. The US Food and Drug Administration stipulate in its extensive guidance for industry that nonclinical testing should support the safety and effectiveness of intracoronary stents and their delivery systems. Bench testing will be enhanced by using improved phantoms that are a better representation of human coronary anatomy. Coronary artery phantoms should be constructed from a material with an appropriate Young's modulus matching the mechanical properties of the coronary artery. Scaffold postdilatation may damage scaffolds by fracturing struts which may have important adverse clinical events. Computational modeling of blood flow is a common tool for investigation of hemodynamic effects in non stented and stented vessels with idealized or patient specific shapes.