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研究进展及存在的问题进行了梳理与分析,并总结了进入创新医疗器械特别审查程序的瓣膜介入治疗产品相关情况。结果表明,当前瓣膜介入治疗领域呈现强劲发展态势,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,该文对未来瓣膜介入治疗新技术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建议。

         

        Abstract: In recent years, cardiac valve interventional devices have developed rapidly, 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 valve interventional devices entering Special Review of Innovative Medical Device. The results show that valve interventional devices are developing rapidly, 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 valve interventional therapy, also puts forward suggestions for the promotion and application of new technologies of valve interventional therapy from the perspective of supervision.

         

      /

      返回文章
      返回