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集采落选、断供警告,难以替代的外周动脉覆膜支架
Xin Lang Cai Jing· 2025-08-25 05:44
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][3]. Group 1: Supply and Demand - 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 [2]. - The exclusion of Gore's stent from the centralized procurement means that its market share has nearly vanished, leading to a supply crisis as suppliers reduce inventory [3][5]. Group 2: Clinical Efficacy - Viabahn stents are shown to have superior clinical efficacy compared to bare metal stents, with a 3-month patency rate of 97.14% versus 90.00% for bare stents [4]. - The unique properties of Viabahn stents, such as flexibility and long lengths (up to 110mm), make them difficult to replace with other products, especially for smaller diameter lesions [9][10]. Group 3: Market Dynamics - The market for peripheral artery stents is largely dominated by foreign brands, with domestic stents holding only 1.8% of the market share [2]. - The price point for lower limb artery stents is significantly lower than that of other interventional devices, which may deter domestic innovation in this segment due to lower profit margins [11][12]. Group 4: Technological Barriers - The production of lower limb artery stents involves higher costs and technical challenges due to the longer lengths required and the need for specific material properties [12][14]. - The complexity of manufacturing covered stents, particularly with heparin coating technology, presents significant barriers for domestic companies [14][16]. Group 5: Emerging Domestic Innovations - Despite challenges, domestic companies like Xinkai Nuo and Hongpu Medical are making strides in developing competitive products, such as the SkyNova peripheral vascular stent, which has shown promising clinical results [17][18]. - The ongoing innovation in the domestic market indicates a potential shift in the competitive landscape for lower limb artery stents, with new products entering centralized procurement processes [18].
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].