赛诺医疗新型血流导向密网支架获批上市 首创颅内自膨药物支架正在注册审批中

Core Insights - Sino Medical has received a medical device registration certificate for its blood flow-guided mesh stent, aimed at treating unruptured wide-necked aneurysms in adult patients [1] - The company is also in the process of registering another innovative product, a self-expanding drug-eluting intracranial stent, which is expected to launch soon [1][4] - The introduction of these innovative products marks a significant growth phase for Sino Medical's neuro-interventional business [1][5] Product Details - The blood flow-guided mesh stent, AUCURA, is the first in China that can be delivered through a 0.017'' system and features an anti-thrombotic coating [2] - Clinical data shows a 6-month aneurysm occlusion rate of 89.78% and a 1-year occlusion rate of 96.99%, the best among similar products [3] - The stent has a low 1-year safety composite endpoint of 1.4%, the lowest in its category [3] Market Potential - The number of mesh stent surgeries in China is projected to grow from approximately 4,500 in 2020 to about 110,000 in 2024, with estimates suggesting it may exceed 160,000 by 2025 [3] - The self-expanding drug-eluting intracranial stent is expected to fill a market gap for treating symptomatic intracranial atherosclerotic stenosis [4] - Current average restenosis rates for intracranial stent procedures stand at 14.8%, highlighting the competitive advantage of Sino Medical's products [5]