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最新!又1款创新器械获批上市!
思宇MedTech· 2025-07-21 10:03
Core Viewpoint - The article highlights the approval of a novel drug-eluting coronary stent system by the National Medical Products Administration (NMPA) in China, marking a significant advancement in the field of interventional cardiology with the introduction of a nickel-free stent that aims to enhance safety and performance [1][4][10]. Group 1: Product Overview - The product, named "YIANCORE益安科尔雷帕霉素药物支架系统," consists of a drug-eluting stent and a rapid exchange balloon dilation catheter delivery system [4]. - The stent's metal framework is made from a high-nitrogen nickel-free stainless steel material (B10SSN4), which eliminates the nickel element found in traditional 316L stainless steel, thereby reducing allergic and inflammatory responses [4][10]. - The stent surface is coated with rapamycin and a biodegradable drug carrier (PLGA), allowing for controlled drug release to inhibit neointimal hyperplasia and reduce the risk of post-operative restenosis [6]. Group 2: Technical Specifications - The B10SSN4 material offers superior tensile strength and pitting potential, with better tissue stability compared to conventional stainless steel, providing enhanced shape retention and magnetic compatibility in complex vascular pathways [7]. - The delivery system incorporates hydrophilic coatings and anti-deformation segment designs to improve accessibility and positioning accuracy in challenging lesions [7]. Group 3: Clinical Applications - The YIANCORE stent system is indicated for patients with ischemic heart disease due to primary coronary artery lesions, with lesion lengths not exceeding 30mm and reference vessel diameters ranging from 2.5 to 4.0mm, covering a broad spectrum of stable and some acute coronary syndrome patients [8]. Group 4: Company Background - Zhongke Yian Medical Technology (Beijing) Co., Ltd., established in April 2010, is a national high-tech enterprise focused on the research, production, and sales of coronary interventional medical devices [11].