主动脉弓支架系统

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财信证券晨会纪要-20250516
Caixin Securities· 2025-05-16 00:34
证券研究报告 2025 年 05 月 16 日 | 袁闯 | 分析师 | | --- | --- | | 执业证书编号:S0530520010002 | | | yuanchuang@hnchasing.com | | | 刘照芊 | 研究助理 | | liuzhaoqian@hnchasing.com | | 晨会聚焦 | 一、财信研究观点 | | --- | 【债券研究】债券市场综述 二、重要财经资讯 【宏观经济】央行开展 645 亿元 7 天期逆回购操作 【财经要闻】最高人民法院、证监会联合发布《关于严格公正执法司法 服 务保障资本市场高质量发展的指导意见》 【财经要闻】2025 年 6 月 1 日起对巴西、阿根廷、智利、秘鲁、乌拉圭 实行免签政策 | 市场数据 | | | | --- | --- | --- | | 指数名称 | 收盘 | 涨跌% | | 上证指数 | 3380.82 | -0.68 | | 深证成指 | 10186.45 | -1.62 | | 创业板指 | 2043.25 | -1.92 | | 科创 50 | 1000.97 | -1.26 | | 北证 50 | 1415.47 ...
先健科技:主动脉弓支架系统获得中国国家药品监督管理局的正式注册批准
Zhi Tong Cai Jing· 2025-05-15 10:21
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]
最新!又1款创新器械获批上市!
思宇MedTech· 2025-05-15 08:12
报名:首届 全球医美科技大会 | 奖项评选 报名: 第二届全球医疗科技大会 | 奖项评选 合作伙伴征集:2025全球手术机器人大会 2025年5月15日,国家药品监督管理局批准了 先健科技(深圳)有限公司 (简称"先健科技")的 " 主动脉弓支架系统 "(国械注准20253130950 )创新产品注 册申请。 该产品包括主动脉弓主体支架系统和主动脉弓分支支架系统,与同公司主动脉覆膜支架破膜系统配合使用,适用于治疗需要 重建左锁骨下动脉血运的Stanford B型 夹层患者 。 截至目前,我国上市的创新医疗器械累计 352 项。 | 索引号 | XZXK-2025-211 | 主题分类 | | --- | --- | --- | | 标题 | 主动脉弓支架系统获批上市 | | | 发布日期 | 2025-05-15 | | # 产品研发背景 主动脉腔内介入治疗 近年来受到临床医生的高度认可,已进入高速发展时期。累及升主动脉及主动脉弓部的病变占全部主动脉夹层病变的 70% 左右,但由于人体 主动脉弓部血管解剖形态复杂并负责颅内供血,一直以来是主动脉疾病腔内治疗的难点,尤其是 弓上3个分支动脉的重建 ,通常面临较大 ...