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获批上市!又1款外周约束型球囊
思宇MedTech· 2025-06-12 08:16
思宇年度活动回顾: 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 即将召开: 2025年7月17日,第二届全球医疗科技大会 2025年9月4-5日,第三届全球手术机器人大会 心未来 近日, 蓝帆医疗 投资孵化的 外周介入板块 上海博脉安医疗科技有限公司 (简称" 博脉安医疗 ") 自主 研发的 金蚕™外周血管约束型球囊扩张导管 (国械注准20253030973)经过国家药品监督管理局审查 批准,正式获批上市。 金蚕™的获批标志着蓝帆医疗布局的外周介入业务线在复杂病变治疗领域再获重大突破。 产品特点 独特设计: 金蚕 ™外周血管约束型球囊扩张导管在半顺应性球囊表面设计了 镍钛记忆合金金属网 结构 ,具有独特 头端螺旋式金属网 设计,避免传统金属丝在回撤时刮擦血管壁,降低血栓风险, 同时保证球囊均匀回抱、安全回撤。 柔顺性增强: 间断镍钛丝网格设计 增强了球囊的柔顺性,确保球囊灵活翻山及通过迂曲病变部位。 随着中国居民生活水平提高以及对健康重视程度的不断提升,未来我国外周动脉介入手术量将不断增长。 近年来,我国外周动脉介入手术量不断增加,因此 国内外周动脉介入支架和球囊市场也将不断扩大 。 根据 ...
获批上市!又1款外周约束型球囊
思宇MedTech· 2025-06-12 08:04
Core Viewpoint - The article highlights the recent advancements in peripheral vascular intervention technology, particularly focusing on the approval and features of the Jin Can™ peripheral vascular balloon dilation catheter developed by Bofei Medical, marking a significant breakthrough in the treatment of complex vascular diseases [1][17]. Product Features - The Jin Can™ catheter features a unique design with a nickel-titanium memory alloy metal mesh structure and a spiral metal mesh design at the tip, which reduces the risk of thrombosis and ensures safe retraction [3][17]. - Enhanced flexibility is achieved through an intermittent nickel-titanium wire mesh design, allowing the catheter to navigate through curved lesions effectively [3]. Market Overview - Peripheral artery disease, characterized by local stenosis or occlusion of peripheral arteries, is expected to see an increase in intervention procedures due to rising health awareness and living standards in China [5]. - The market for peripheral artery intervention balloons and stents in China is projected to grow to 6.8 billion yuan by 2030, driven by the increasing volume of procedures [5]. Market Growth Rates - The growth rates for balloon and stent markets from 2017 to 2030 are as follows: - Balloons: 30.5% (2017-2021), 21.5% (2021-2025E), 13.8% (2025E-2030E) - Stents: 14.7% (2017-2021), 11.0% (2021-2025E), 5.7% (2025E-2030E) - Overall market: 21.7% (2017-2021), 16.8% (2021-2025E), 11.0% (2025E-2030E) [7]. Competitive Landscape - The domestic PTCA balloon catheter market is characterized by significant competition, with major players including Demark, MicroPort, Lepu Medical, and Bofei Medical. However, foreign companies hold over 60% of the market share, with Boston Scientific and Medtronic accounting for nearly 50% [8][9]. - There remains substantial room for domestic manufacturers to increase their market share in the PTCA balloon catheter segment [9]. Recent Approvals - Bofei Medical's Jin Can™ balloon catheter was approved for market entry in June 2025, and the company has developed a comprehensive product matrix for peripheral vascular interventions [17]. - Other recent approvals include the SeaDragon™ ultra-high-pressure balloon catheter by Lanpai Medical and the peripheral balloon catheter by Youdebang Medical, both designed for various vascular applications [12][15]. Company Background - Bofei Medical, established in 2020, has developed a complete product line for peripheral vascular interventions, including the Jin Can™ catheter and other related products [17]. - Lanpai Medical, founded in 2002 and listed on the Shenzhen Stock Exchange, is a leading medical device company with a diverse portfolio covering various medical fields, including cardiovascular interventions [18].