智通财经APP讯,心通医疗-B(02160)发布公告,于2024年12月16日,集团自主研发的第三代经导管主动脉瓣植入术(TAVI)产品VitaFlow Liberty® Flex经导管主动脉瓣可回收可控弯输送系统(“VitaFlow Liberty® Flex”)获得中国国家药品监督管理局颁发的注册批准。
VitaFlow Liberty® Flex为VitaFlow Liberty®输送系统的升级款产品,可与集团已获批的主动脉瓣膜配合使用,其传承了VitaFlow Liberty®输送系统的所有优势,并创新性地增加了3D空间调弯功能。其独有的内管调弯技术可使瓣膜在释放过程中保持同轴,植入更稳定精准,过弓以及跨瓣也更顺畅安全。同时 VitaFlow Liberty® Flex实现了瓣膜释放的交界对齐,保护冠脉通路,为未来冠脉介入预留空间。该产品为医生提供更优异的易用性体验,进一步提升手术效率和安全性,并减少手术并发症发生。此外,得益于公司产品全生命周期管理理念在研发阶段的深度实践,VitaFlow Liberty® Flex将有助于公司进一步降低生产成本。
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