图：Ankura Plus主体支架和CSkirt裙边分支支架 中国医工原创 定义原位开窗技术新标准 2025年5月14日，由国家心血管病中心、中国医学科学院阜外医院舒畅教授领衔，与先健科技 (01302.HK)联合研发的主动脉原位开窗分支重建创新产品矩阵，成功获得国家药品监督管理局(NMPA) 批准，重磅上市。为全球首创重建弓部分支的原位开窗(ISF)创新产品解决方案，填补了行业空白，定 义原位开窗技术新标准，推动主动脉腔内重建全面迈入精准化、规范化新时代! 该主动脉原位开窗分支重建创新产品矩阵由Ankura Plus 原位开窗分支重建主体支架和原位开窗自适应 防漏CSkirt裙边分支支架组成，结合复旦大学附属中山医院符伟国教授与先健联合研发的Futhrough 破 膜系统和Fustar 可调弯鞘，构建成了先健全球首创"三位一体"原位开窗分支重建一站式解决方案。不仅 为临床医生提供了前所未有的ISF技术专用解决方案，也为累及分支的主动脉病变患者带来了更优更丰 富的治疗新选择。 主动脉夹层和动脉瘤是危害极大的心血管疾病，因破裂风险高，常致严重出血甚至猝死。约2/3胸主动 脉夹层累及升主动脉与弓部，常需处理弓上分 ...

Core Viewpoint - The announcement highlights the approval of the aortic arch stent system by the National Medical Products Administration of China, marking a significant advancement in the treatment of Stanford type B aortic dissection patients through innovative technology [1][2] Group 1: Product Approval and Features - The aortic arch stent system is the first of its kind approved for the specific use of windowing technology in aortic arch branch reconstruction, aimed at treating Stanford type B aortic dissection [1] - The system consists of the AnkuraTM Plus aortic arch main stent system and the CSkirtTM aortic arch branch stent system, which entered the "Special Review Procedure for Innovative Medical Devices" in 2022 [1] - Clinical research involving 120 participants demonstrated a technical success rate of 97.5% during surgery, a branch vessel patency rate of 99.1% after one year, and a low type III endoleak occurrence rate of only 1.8% [1] Group 2: Technological and Market Implications - Windowing technology is recognized as a mainstream technique for reconstructing aortic arch branches in thoracic endovascular aortic repair (TEVAR), with international guidelines recommending its use for patients with insufficient anchoring zones or affected left subclavian arteries [2] - The company holds independent intellectual property rights for the product, which is expected to provide a complete, safe, and effective endovascular treatment solution for aortic dissection involving the aortic arch [2] - The product's market approval enhances the company's product portfolio in the peripheral vascular intervention field, aiming to offer a more flexible, comprehensive, and user-friendly solution for aortic arch endovascular reconstruction [2]