生物可吸收镁合金加压螺钉

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获批创新器械!生物可吸收镁合金加压螺钉
思宇MedTech· 2025-07-01 09:05
Core Viewpoint - The article highlights the innovative development and market potential of Syntellix AG's bioabsorbable magnesium alloy implants, particularly the MAGNEZIX® series, which offer significant advantages over traditional metal implants in orthopedic surgeries [2][23]. Product Introduction - Syntellix AG's "bioabsorbable magnesium alloy compression screws" are made from magnesium-based alloy MgYREZr, designed to gradually degrade and be replaced by endogenous new tissue in the body [2][4]. - The MAGNEZIX® product line includes various types of screws and implants, such as MAGNEZIX® CS for small bone fractures and MAGNEZIX® CBS with enhanced antibacterial properties [4][9]. Key Features - The magnesium alloy's biomechanical properties closely resemble human bone, promoting bone growth and regeneration [8]. - The screws are designed to fully degrade within approximately 12 months, eliminating the need for removal surgeries and reducing the risk of secondary operations [9][11]. Clinical Research and Performance - MAGNEZIX® screws have been used in thousands of surgeries globally, demonstrating superior bone healing rates and patient satisfaction compared to traditional non-degradable metal implants [10][19]. - A study comparing MAGNEZIX® CS screws with titanium screws in Hallux valgus surgeries showed no significant difference in stability, bone healing, and patient satisfaction, with a 100% satisfaction rate reported [10][11]. Market Overview - The global orthopedic implant market is projected to grow from $47.38 billion in 2024 to $71.74 billion by 2032, with a compound annual growth rate of 5.3% [22]. - The demand for bioabsorbable implants is increasing due to their natural degradation properties and compatibility with bone tissue, positioning magnesium alloys as a new direction in the industry [22]. Company Background - Syntellix AG, founded in 2008 and headquartered in Hannover, Germany, specializes in the development and sale of bioabsorbable metal implants made from magnesium alloys [23]. - The company claims its implants can reduce surgical time, costs, pain, and infection risks by half compared to traditional titanium or steel implants [23].
最新!又3款创新器械获批上市!
思宇MedTech· 2025-06-27 09:07
思宇年度活动回顾: 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 | 首届全球医美科技大会 即将召开: 2025年7月17日,第二届全球医疗科技大会 2025年9月3-5日,第三届全球手术机器人大会 公司介绍 中欧智薇(上海)机器人有限公司是华科润旗下子公司, 专注于数字化骨科产品和微型手术机器人技术。 2021年底,华科润与欧洲创新手术机器人公司 Interventional Systems(简称 INS)在上海合作成立中欧智薇(上海)机器人有限公司,向市场推出 具有显著差异 化及创新性的新一代微型骨科手术机器人 。 ▲图片源 自公司官方公众号 2025年6月27日,国家药品监督管理局批准了 中欧智薇(上海)机器人有限公司 的 "脊柱外科手术导航定位设备" (国械注准20253011259), 深圳迈微医疗 科技有限公司 的" 心脏脉冲电场消融设备 "(国械注准20253011258)和 德国新特利斯股份公司 的" 生物可吸收镁合金加压螺钉 "(国械注进20253130280) 三个创新产品注册申请 。 截至目前,我国上市的创新医疗器械累计 360 项。 | 358 | 脊柱外科手术导航定 ...