心脉医疗 20250828 摘要 心脉医疗 2025 年上半年营收 7.14 亿元，国内收入约 6 亿元，海外收入 约 1.23 亿元，海外销售收入同比增长超过 95%，占比提升至 17%，主 要受益于朗巴并表及海外业务增长，并新增获得 8 张海外注册证书。 公司持续推进全球化战略，国内市场累计进入超过 2,700 家医院，覆盖 全国 31 个省份及港澳地区；国际业务方面，积极推进欧洲、拉美、亚 太等区域市场准入，并推动新产品在欧洲和日本的上市前临床试验。 在主动脉介入领域，Coretex 分支型主动脉覆膜智驾系统获批上市， AG42 腹主动脉覆膜智驾系统完成上市前临床随访，HACK 胸主动脉多 分支覆膜智驾系统进入国家创新医疗器械特别审查程序。 外周动脉介入领域，可解脱带纤维毛栓塞弹簧圈处于国内注册审评阶段， 膝下药物球囊扩张导管完成上市前临床随访，带纤维毛栓塞弹簧圈顺利 开展上市后临床应用，静脉保护伞有望明年拿到注册证书。 肿瘤介入领域，经颈静肝内穿刺套件获批上市，Tips 覆膜智驾系统及两 款蒜菜微球处于国内注册审评阶段，预计酸菜微球将在今年下半年拿到 国内注册证书。 Q&A 心脉医疗 2025 年上半 ...

Group 1 - Jiangsu Changyida Medical Technology Co., Ltd. and Morningstar (Nantong) Medical Device Co., Ltd. have received approval from the National Medical Products Administration for their innovative Class III medical devices, namely the "Intracranial Aneurysm Assisting Embolization Stent" and the "Pulmonary Artery Thrombectomy Stent System" respectively [1][2] - In 2023, a total of 9 innovative Class III medical devices have been approved for market entry in Jiangsu Province [1] - The "Intracranial Aneurysm Assisting Embolization Stent" features a self-expanding elastic structure with adjustable length and flared ends, aimed at reducing vascular damage and enhancing vascular adhesion [1] Group 2 - The "Pulmonary Artery Thrombectomy Stent System" is designed for mechanical thrombectomy via the femoral vein, utilizing a large-caliber thrombus suction catheter to quickly restore blood flow [2] - This device offers a short preoperative preparation time, high efficiency in thrombus removal during the procedure, and rapid postoperative recovery [2] - The stent system includes various models with a gradient design for the mesh disk, which is intended to be more compatible with target blood vessels and reduce the risk of vascular damage [2] Group 3 - The Jiangsu Provincial Drug Administration is focusing on core technology breakthroughs and addressing "bottleneck" technologies to promote innovative medical device development [3] - The administration aims to enhance the transformation of clinical research results into practical applications, fostering collaboration between medical and industrial sectors [3] - Efforts are being made to reform the review and approval system, optimize the industrial ecosystem, and increase the international competitiveness of high-end medical devices in Jiangsu Province [3]