血管介入导管创新产品技术审评的研究方法选择与实践应用

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

      • 摘要: 血管介入导管作为现代介入诊疗的核心工具,其创新产品的科学审评对医疗器械监管具有重要意义。该文首先系统梳理了血管介入导管的技术发展现状与审评关注点;其次聚焦在体外模型实验、计算机模拟仿真、动物体内试验及人体临床试验等研究方法,对比分析不同方法优缺点、使用场景、证据等级等方面的差异;最后结合创新产品审评案例,阐述了不同产品的风险评估思路。本研究为血管介入导管创新产品的技术审评提供基本思路和实践指导,有助于提高技术审评质效。

         

        Abstract: 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.

         

      /

      返回文章
      返回