赛诺医疗：冠脉产品获得国内医疗器械注册证

Core Viewpoint - The company has received the Medical Device Registration Certificate for its drug-eluting stent system, indicating a significant advancement in its product offerings in the coronary stent category [1][2]. Group 1: Product Details - The drug-eluting stent system consists of a drug-coated stent and a rapid exchange balloon catheter delivery system [1][2]. - The stent is made from L605 cobalt-chromium alloy and features a non-degradable bottom coating of poly(butyl methacrylate) (PBuMA) and a biodegradable drug coating composed of rapamycin and poly(lactic-co-glycolic acid) (PLGA) [1][2]. - The drug dosage density of the stent is 1.20 μg/mm², with a drug loading range of 59 μg to 324 μg [1]. Group 2: Application and Usage - The product is designed for use in patients with ischemic heart disease, specifically for improving symptoms of vascular stenosis [1]. - It is applicable for blood vessels with diameters ranging from 2.25 mm to 5.00 mm and lesion lengths of up to 40 mm [1].