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最新!2款创新器械获批上市

Group 1: Innovative Medical Devices - Beijing Bairen Medical Technology Co., Ltd. received approval for its "Transcatheter Valve-in-Valve System," which is designed for patients with symptomatic heart disease due to the failure of previously implanted surgical bioprosthetic mitral valves [5][6] - The system includes components such as a biological valve, delivery system, balloon dilation catheter, catheter sheath kit, gripping device, and inflation pump, utilizing materials like bovine pericardial leaflets and cobalt-chromium alloy [5][6] - As of now, there are a total of 351 innovative medical devices approved for market in China [6] Group 2: Biodegradable Bone Repair Materials - Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd. has received approval for its "Magnesium-based Biodegradable Polymer Bone Repair Material," which is suitable for filling and repairing bone defects in limbs without compromising structural stability [10] - The material is composed of PLGA, β-TCP, and magnesium, manufactured using low-temperature additive manufacturing technology [10] - The company was established in 2013 and focuses on the research and production of new orthopedic implants, cardiovascular stents, and high-tech medical products [10]