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外周药物洗脱支架
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断供警告,这款市场需求量第三的器械用不上了?
3 6 Ke· 2025-08-25 02:22
Core Viewpoint - The supply of Viabahn covered stents from W. L. Gore & Associates is becoming increasingly tight, leading to temporary procurement requests from medical institutions due to its exclusion from the national centralized procurement list [1][2]. Group 1: Product Overview - Viabahn covered stents are self-expanding peripheral vascular stent systems developed by Gore, primarily used for treating peripheral artery diseases and complex vascular lesions [1]. - The annual procurement demand for lower limb artery stents in China is approximately 123,000 units, with Gore's peripheral artery stent demand ranking third at 18,476 units [1][2]. Group 2: Market Dynamics - Gore's exclusion from the centralized procurement process has resulted in a significant reduction in its market share, leading to a supply crisis as suppliers cut back on inventory [2]. - The existing medical devices cannot fully replace the Viabahn stent, as alternatives are inferior in terms of length, flexibility, and clinical efficacy [2][8]. Group 3: Clinical Efficacy - Clinical studies indicate that the one-year patency rate for Viabahn stents is significantly higher than that of bare metal stents, with rates of 80% compared to 52.5% for the latter [3]. - Viabahn stents are particularly effective for treating long lesions, with the ability to address lesions up to 110mm in length, unlike other covered stents that require multiple stents for longer lesions [9]. Group 4: Competitive Landscape - The market for peripheral artery stents is largely dominated by foreign brands, with domestic stents holding only 1.8% of the total demand [1][2]. - Despite the challenges, some domestic companies like Xinkainuo and Hongpu Medical are making strides in developing competitive products, including the SkyNova peripheral vascular stent [16][17]. Group 5: Technical Barriers - The production of lower limb artery stents involves higher costs and technical barriers compared to other types of stents, which has deterred domestic innovation in this area [11][12]. - The complexity of manufacturing covered stents, particularly with heparin coating technology, presents significant challenges for domestic manufacturers [15].
最新!9款医疗器械进入创新通道
思宇MedTech· 2025-02-20 03:49
合作伙伴征集:2025全球手术机器人大会 报名:首届全球眼科大会 | 展位有限 1 .产品名称:外周动脉覆膜支架系统 申请人:江苏朴芃医疗科技有限公司 江苏朴芃医疗科技有限公司成立于2019年12月16日,是 臻亿医疗子公司, 其核心产品包括PAFLIVE ® 冠脉冲击波球囊导管系统及外周血管类医疗器械,其中, PAFLIVE ® 冠脉冲击波球囊导管系统利用冲击波技术对冠脉内钙化病变进行预处理,能够安全高效地破坏浅表与深层钙化,恢复血管弹性及血流,填补了国内相关 技术的空白。 2.产品名称:外周药物洗脱支架 申请人:上海畅德医疗科技有限公司 畅德医疗成立于2021年11月,位于上海。公司创始人及核心团队拥有丰富的介入耗材研发、临床注册和商业化经验,对聚焦的行业有深刻的理解。 畅德医疗秉承研发创新的核心理念,致力于高效打造一个能够满足血管疾病微创伤治疗的完整解决方案。公司在下肢动脉狭窄介入治疗、血栓管理、静脉疾病介入 治疗及慢性疾病管理等治疗领域发力,推出了外周血管约束型球囊扩张导管、间歇脉冲加压理疗仪、外周血栓抽吸系统等多款产品。 报名:首届全球心血管大会 | 奖项评选 报名:首届全球骨科大会 | 奖项评选 ...