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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
Core Insights - The article highlights the upcoming global medical technology conferences and recent approvals of innovative medical devices in China, emphasizing the growth and innovation in the medical technology sector [1][13]. Group 1: Medical Device Approvals - On June 27, 2025, three innovative medical devices received approval from the National Medical Products Administration of China, including a spinal surgery navigation device, a cardiac pulsed electric field ablation device, and a biodegradable magnesium alloy screw [1][2]. - As of now, a total of 360 innovative medical devices have been approved for market in China [1]. Group 2: Spinal Surgery Navigation Device - The spinal surgery navigation device from China-Europe Zhihui (Shanghai) Robot Co., Ltd. is the first in China to utilize micro robotic arm technology, allowing for precise spatial positioning during adult spinal surgeries [3]. - This device significantly reduces the space occupied in the operating room compared to traditional multi-axis robotic arms, enhancing safety and efficiency [3]. Group 3: Cardiac Pulsed Electric Field Ablation Device - The cardiac pulsed electric field ablation device from Shenzhen Maiwei Medical Technology Co., Ltd. is designed for treating drug-resistant, recurrent, symptomatic, and paroxysmal atrial fibrillation [8]. - It is the first device to use nanosecond pulse width high-voltage electric fields for pulmonary vein isolation, providing real-time monitoring and feedback during the ablation process [8]. Group 4: Biodegradable Magnesium Alloy Screw - The biodegradable magnesium alloy screw from Syntellix AG is made from a magnesium-based alloy and is designed to gradually degrade and be replaced by endogenous new tissue within the body [11][12]. - Compared to traditional titanium or steel implants, this product claims to reduce surgical time, costs, pain, and infection risks by half [12].