深度｜血管支架、心脏缝线仍被进口产品主导，国产医疗器械能否“吃下”巨大市场

Core Insights - The reliance on imported high-value medical consumables in China is decreasing as domestic brands emerge in critical areas such as intracranial aneurysm embolization devices, cardiac sutures, heart valves, artificial blood vessels, and ECMO consumables [1][4] - In the first half of this year, China approved 45 innovative medical device products, and the results of centralized procurement for peripheral vascular stents have been implemented in multiple provinces [1][2] Group 1: Market Dynamics - The fifth batch of centralized procurement results shows that 18 companies, including both multinational and domestic firms, have been selected, with prices for stents dropping by over 80% [2][3] - The exit of Gore from the procurement process has led to supply shortages for its self-expanding covered peripheral vascular stent, VIABHAN, which was previously the only option for small vessels [2][3] - The demand for peripheral vascular implants is significant, with 200,000 to 300,000 patients treated annually, yet domestic products currently hold less than 10% of the procurement share [3] Group 2: Challenges in Domestic Production - Domestic manufacturers are developing products to compete with Gore's stent, but face challenges in material quality and production processes [4][5] - The production of small vascular covered stents is particularly challenging due to stringent requirements for flexibility, support, and leakage prevention [3][4] - The heart suture market remains dominated by imports, with no domestic alternatives currently available for critical applications [6][7] Group 3: Clinical Implications - The shortage of small vascular covered stents has forced clinicians to seek temporary procurement solutions, which can take one to two weeks [3] - In pediatric cardiac care, the lack of suitable domestic devices leads to reliance on adult products, creating operational delays [7][8] - The mechanical valve market in China is largely unaddressed by domestic manufacturers, with only a few multinational companies providing these products [7][8] Group 4: Future Outlook - The potential for supply shortages in specific medical device areas exists if domestic solutions are not developed in time [9] - The market for interventional valves is attractive due to shorter development cycles and higher profit margins, which may incentivize domestic companies to invest [8]