LineMatrix耐迈通®生物型人工血管
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通畅率100%!首个国产完全生物型人工血管
思宇MedTech· 2025-06-10 09:54
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 即将召开: 2025年6月12日,首届全球医美科技大会 2025年7月17日,第二届全球医疗科技大会 2025年9月4-5日,第三届全球手术机器人大会 心未来 2025年6月6日, 海迈医疗科技(苏州)有限公司 (简称" 海迈医疗 ")宣布旗下 首个国产生物型人工 血管 LineMatrix 耐迈通 ® FIM临床试验在浙江大学医学院附属邵逸夫医院肾内科与血液净化中心圆满完 成随访。 当前,心血管疾病已成为全球首要死亡原因。其中,人体血管是 "心血管系统的关键桥梁和网络"。当人 体血管出现病变时,需要人工血管予以替代治疗。人工血管在临床中发挥着极为重要的作用,包括用于慢 性肾透析血管通路建立、下肢动脉外伤血管替代、下肢及颈动脉粥样硬化搭桥及冠状动脉搭桥术等。 但是, 小口径人工血管(内径 ≤6mm) 在临床使用过程中面临一系列问题。 传统高分子材料膨体聚四 氟乙烯(ePTFE) 小口径人工血管临床使用近50年,主要由戈尔、巴德、迈柯唯等海外企业垄断。 ePTFE小口径人工血管的两大缺陷: 易形成血栓造成通畅率低 和 感染发生率 ...
海迈医疗完成国产生物型人工血管首次人体试验
Su Zhou Ri Bao· 2025-06-10 04:00
Core Insights - Haimai Medical Technology (Suzhou) Co., Ltd. has completed the follow-up of its first domestic biological artificial blood vessel, LineMatrix Naimaitong® FIM clinical trial, marking it as the first company in China to achieve this milestone [1][2] - The clinical trial demonstrated high patency rates for the biological artificial blood vessel, with a primary patency rate of 90.9% at three months and 80.8% at six months, significantly outperforming traditional ePTFE artificial blood vessels [2][3] - The company plans to initiate nationwide multi-center product registration clinical trials for the Naimaitong® biological artificial blood vessel to accelerate its market launch and is also developing a groundbreaking 3.5mm diameter artificial blood vessel [3] Summary by Sections Company Overview - Haimai Medical is recognized for its innovative approach in developing the first domestic biological artificial blood vessel, which addresses the limitations of existing treatment methods for vascular injuries [1][2] Clinical Trial Results - The FIM clinical trial results showed that the biological artificial blood vessel had a primary patency rate of 90.9% at three months and 80.8% at six months, with a cumulative patency rate of 100% [2] - No immune reactions, infections, or complications such as aneurysms were reported, indicating the safety and effectiveness of the product [2] Market Implications - The high patency rates and reduced need for postoperative interventions suggest that the biological artificial blood vessel could significantly lower healthcare costs and alleviate the financial burden on patients [2] - The company aims to replace traditional ePTFE artificial blood vessels with its innovative product, potentially benefiting a large patient population [2][3] Future Developments - Haimai Medical is set to launch nationwide multi-center clinical trials for product registration, aiming for the commercialization of its biological artificial blood vessel [3] - The company is also working on a pioneering 3.5mm diameter artificial blood vessel, which could revolutionize coronary artery bypass surgery techniques and outcomes [3]