医疗器械大动物试验操作规范与实践指南:介入类产品临床前研究的应用与实践OA

Large animal studies serve as an indispensable scientific bridge for high-risk interventional medical devices transitioning from preclinical research to human clinical trials.Guided by China's regulatory framework,including the Guidelines for Registration Review of Animal Studies of Medical Devices,this paper systematically reviews the technical considerations and developmental trends of large animal studies in the preclinical evaluation of interventional medical devices.First,the suitability of pigs,sheep,dogs,and non-human primates is comparatively analyzed in terms of anatomical structure,physiological characteristics,and coagulation mechanisms,highlighting the broad applicability of porcine models in cardiovascular and neurointerventional evaluations.Second,the status of major disease models is reviewed,including acute peripheral arterial thrombosis and aspiration models,selective renal artery embolization models,atherosclerosis models,acute myocardial infarction models,calcific valvular disease models,and chronic heart failure models.The clinical predictive value of techniques such as autologous thrombus formation,chemical induction,and genetic modification is also compared.Furthermore,the paper emphasizes that experimental design should follow the principles of randomization and multi-time-point observations.An evaluation framework encompassing safety,efficacy,and operational performance is systematically summarized,along with corresponding pathological quantification standards.Finally,in response to current challenges such as model limitations,ethical constraints,and high costs,the paper discusses the potential of emerging technologies,including advanced imaging,artificial intelligence,computational modeling,and organ-on-a-chip systems,to enhance evaluation precision and ethical alignment.This study aims to provide a systematic and scientific technical reference for the R&D design and registration of interventional medical devices,thereby facilitating clinical translation and advancing precision regulation of high-risk devices in China.