获批上市！360°外周抽吸导管

Core Viewpoint - Guangzhou Yijie Medical Technology Co., Ltd. has received NMPA approval for its Yijie Xingyi™ peripheral blood thrombus aspiration catheter, which is designed to remove thrombus from the peripheral vascular system [2]. Group 1: R&D Background - Peripheral arterial thromboembolic diseases primarily include arterial embolism and thrombosis, often presenting acutely, with some cases being subacute or chronic [4]. - Treatment methods for acute lower limb arterial thrombosis include anticoagulation therapy, surgical revascularization, interventional procedures, and in severe cases, amputation [4]. - Advances in technology have led to an increased application of endovascular treatments [4]. Group 2: Disease Overview - Deep vein thrombosis (DVT) is a common and challenging peripheral thromboembolic disease, characterized by blood clot formation in deep veins, leading to blood flow obstruction [6]. - In 2021, there were 1.8 million hospitalized patients with venous thromboembolism (VTE) in China, with a prevalence rate of 127.8 per 100,000 people, making it the third most common vascular disease after ischemic heart disease and stroke [6]. - Major treatment options for DVT include anticoagulation, catheter-directed thrombolysis, percutaneous mechanical thrombectomy (PMT), and surgical thrombectomy [6]. - PMT has gained recognition among clinical experts and is recommended as a first-line surgical treatment for thrombus removal in recent guidelines [6]. Group 3: Product Introduction - Yijie Medical's peripheral thrombus aspiration catheter addresses significant clinical treatment needs and features an innovative adjustable separator to enhance thrombus removal efficiency [7]. - The product consists of an aspiration catheter and accessories, designed for effective thrombus clearance [9]. Group 4: Company Overview - Established in August 2020, Yijie Medical is located in Huangpu District, Guangzhou, and focuses on the R&D, production, and sales of interventional medical devices [13]. - The company has received NMPA registration for 13 products and FDA approval for 2 products, expanding its commercial presence in regions including South America, East Asia, Southeast Asia, Central Asia, and the Middle East [13]. - The company has recently won bids for its neurointerventional products in public medical institutions in Henan Province [15].