From bench to bedside: A narrative review and institutional experience with experimental models for vascular device design and translation

Abstract

The past 2 decades have seen a rise in vascular innovations and a rapid evolution in endovascular device technology, with the emergence of atherectomy, intravascular lithotripsy, drug elution technology, thrombectomy devices, and many more. Like all other medical devices, vascular devices undergo a life cycle composed of a concept phase, a planning and design phase, a regulatory process, a launch phase, and a post-market stage. Experimental and preclinical models are required at various stages of the life cycle to aid in the designing, refining, and feasibility testing of novel devices before they are transferred to clinical practice. The experimental testing of these devices relies heavily on the ability to simulate human anatomy and physiology, and to mimic or induce specific disease processes. Computational and benchtop models play very important roles at the early stages of the manufacturing process, and animal and cadaveric models are indispensable for testing the mechanistic performance, safety, and efficacy of novel devices before they are used in clinical trials and regulatory approval is obtained for public use.