Methodological Selection and Practices Application in the Technical Evaluation of Innovative Vascular Interventional Catheter Products

As essential tools in modern interventional diagnosis and therapy, vascular interventional catheters demand rigorous scientific evaluation for their innovative products, which holds significant importance for medical device regulation. This study first systematically summarizes the current technological developments and key evaluation considerations for vascular interventional catheters. Furthermore, It provides a comparative assessment of various research methodologies, including in vitro model experiments, computer simulation, in vivo animal experiments and human clinical trials, focusing on their respective advantages and limitations, application scenarios, and evidentiary value. Finally, through analysis of innovative device evaluation case studies, it expounds on the risk assessment ideas for different products. This study provides a basic train of thought and practical guidance for the technical review of vascular interventional catheters, which is conducive to enhancing the quality and efficiency of technical reviews.