最新！2026年首款创新医疗器械获批！

Core Viewpoint - Shanghai Weimi Medical Technology Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for its self-expanding aneurysm embolization device, MeshCoil®, marking it as the first domestically approved device for treating wide-neck bifurcation intracranial aneurysms in China [2][3]. Clinical Pain Points - Bifurcation wide-neck aneurysms are considered a challenging subtype in intracranial aneurysm intervention due to their complex anatomical structures and the need for effective treatment strategies that minimize long-term intervention on normal vascular structures while ensuring adequate neck coverage [5]. Product Introduction - MeshCoil® utilizes an "intra-aneurysmal turbulence" technology, positioned within the aneurysm cavity to alter hemodynamic conditions and promote thrombosis, thereby occluding the aneurysm. This device aims to provide a supplementary solution for specific complex aneurysm morphologies, bridging the gap between stent-assisted coiling and flow diversion devices [6][7]. Design and Materials - The device is made from nickel-titanium alloy and composite wire, featuring self-expanding properties. Its design focuses on achieving neck coverage and device stability while minimizing long-term effects on normal vascular segments [7][10]. Clinical Validation - A multi-center clinical trial led by Xuanwu Hospital of Capital Medical University included 139 participants, demonstrating that MeshCoil® exhibits good safety and efficacy in treating bifurcation wide-neck aneurysms. The results indicated a 12-month complete occlusion rate of 88.5% and a bleeding rate of 0.7% [11][13]. Company Overview - Shanghai Weimi Medical Technology Co., Ltd. is based in the Zhangjiang International Medical Park in Shanghai, focusing on innovative technology development and promotion in the field of minimally invasive and precision medicine, particularly for intracranial aneurysms [12].