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. 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. 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. NUMEN™ Silk underscores MicroPort NeuroScientific’s commitment to providing clinicians with safer, more effective treatment options through continuous innovation.
About Coil Embolization
Intracranial aneurysms are localized abnormal dilation of the cerebral artery walls that form aneurysmal bulges. They are typically asymptomatic until rupture, which can result in high mortality and disability rates, leading to the nickname “cerebral ticking bombs”. Coil embolization is a common minimally invasive interventional surgical method used to treat aneurysms. This procedure involves delivering metal coils precisely to the aneurysm via an intravascular catheter, which are then released to fill the aneurysm sac, preventing further blood flow into the aneurysm and reducing the risk of rupture.
About MicroPort NeuroScientific
MicroPort NeuroScientific (MicroPort NeuroScientific Corporation; HKEX: 2172), an associated company of MicroPort® (MicroPort Scientific Corporation; HKEX: 00853), is committed to the research and development of high-end medical devices in the field of neurological interventional treatment with solutions that currently support over 120 cerebrovascular stenting procedures every day. In the future, MicroPort NeuroScientific will continue investing more resources in the innovation and development to provide more high-quality and innovative cerebrovascular and neuro-interventional solutions for physicians and patients.
More information is available at: microportneurosci.com
