心脏瓣膜介入创新医疗器械现状及发展动态分析

      Current Situation and Development Trends Analysis of Innovative Medical Devices for Heart Valve Intervention

      • 摘要: 近年来,心脏瓣膜介入治疗领域发展迅速,各种新技术不断得到应用。该文对国内外主动脉瓣、肺动脉瓣、二尖瓣和三尖瓣介入治疗产品的研究进展及存在的问题进行了梳理与分析,并总结了进入国家药品监督管理局创新医疗器械特别审查程序的心脏瓣膜介入治疗产品的情况。研究结果表明,当前心脏瓣膜介入治疗领域发展态势强劲,但在瓣膜耐久性、操作适宜性、减少并发症等方面有待改进。最后,该文对未来心脏瓣膜介入治疗新技术的发展趋势进行了展望,并从监管角度对心脏瓣膜介入治疗新技术的推广和应用提出了建议。

         

        Abstract: In recent years, the field of heart valve interventional treatment has developed rapidly, and various new technologies have been continuously applied. The study provides a comprehensive review and analysis of the research progress and challenges related to interventional treatment products for the aortic valve, pulmonary valve, mitral valve, and tricuspid valve both domestically and internationally. The study also summarizes the status of heart valve interventional devices entering Special Review of Innovative Medical Device of National Medical Products Administration (NMPA). The results show that the field of valve interventional treatment is developing rapidly, but there is still room for improvement in terms of valve durability, operational suitability, and complication reduction. Lastly, the study looks forward to the future development trend of new technologies for heart valve interventional therapy, and puts forward suggestions for the promotion and application of new technologies of valve interventional therapy from the perspective of supervision.

         

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