集采落选、断供警告，难以替代的外周动脉覆膜支架

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].