Washington, USA, 23 October 2024 - On September 30, MicroPort NeuroTech (Shanghai) Co., Ltd., a subsidiary of MicroPort NeuroScientific, received US FDA clearance for the NUMEN™ Silk Coil Embolization System (NUMEN™ Silk), marking its entry into the US market, its second international market after China. NUMEN™ Silk is an upgraded version of the company’s NUMEN™ Coil Embolization System (NUMEN™), which was first approved for marketing in China in September 2020 and has since received regulatory clearance in the US, and approvals in the EU, South Korea, Brazil, and Japan.

2024年10月23日，美国华盛顿-9月30日，MicroPort NeuroTech（上海）有限公司（MicroPort NeuroScientific的子公司）获得了美国FDA对NUMEN™丝圈栓塞系统（NUMEN™Silk）的许可，标志着其进入美国市场，这是继中国之后的第二个国际市场。NUMEN™Silk是该公司NUMEN™线圈栓塞系统（NUMEN™）的升级版，该系统于2020年9月首次获准在中国上市，此后在美国获得监管许可，并在欧盟、韩国、巴西和日本获得批准。

NUMEN™ Silk is designed for the embolization of small to mid-sized aneurysms, micro-sized aneurysms, and ruptured aneurysms. Its “3-D” and “Ω+S” structure provides superior compliance with irregular aneurysm walls, and is available in a various diameters and lengths, offering more options for clinical application. NUMEN™ Silk is a next-generation, ultra-soft, electrolytically detachable coil system with extra-fine primary coil wires that maintain coil softness, help to reduce pressure on the aneurysm wall, and lower the risk of rupture during surgery. Additionally, the pusher of NUMEN™ Silk features an ultra-soft distal end that increases flexibility, making it as soft as the coils themselves.

NUMEN™Silk专为栓塞中小型动脉瘤、微型动脉瘤和破裂动脉瘤而设计。它的“3-D”和“Ω+S”结构提供了对不规则动脉瘤壁的优异依从性，并且具有各种直径和长度，为临床应用提供了更多选择。NUMEN™Silk是一种下一代超柔软的电解可拆卸线圈系统，具有超细的初级线圈，可保持线圈柔软，有助于降低动脉瘤壁的压力，并降低手术期间破裂的风险。此外，NUMEN™Silk的推进器具有超软的远端，可增加灵活性，使其与线圈本身一样柔软。

This, combined with the ultra-short detaching zone, helps to reduce kick-back effects during the procedure, enabling smooth filling and resulting in safer and more effective aneurysm embolization.While FDA clearance is a significant milestone, the true impact of NUMEN™ Silk lies in its potential to transform hemorrhagic stroke treatment.

这与超短的分离区相结合，有助于减少手术过程中的反冲效应，从而实现平滑的填充，并导致更安全，更有效的动脉瘤栓塞。虽然FDA的批准是一个重要的里程碑，但NUMEN™Silk的真正影响在于其改变出血性中风治疗的潜力。

NUMEN™ Silk underscores MicroPort NeuroScientific's commitment to providing clinicians with safer, more effective treatment options through continuous innovation.  About Coil Embo.

NUMEN™Silk强调了MicroPort NeuroScientific通过不断创新为临床医生提供更安全，更有效的治疗选择的承诺。关于线圈Embo。