Washington, USA, October 21, 2024 — On September 30, MicroPort NeuroTech (Shanghai) Co., Ltd., the subsidiary of MicroPort NeuroScientific received US FDA clearance for NUMEN™ Silk Coil Embolization System (NUMEN™ Silk), marking its second international market clearance following its initial clearance in the US.
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 clearance in the US, and approvals in the EU, South Korea, Brazil, and Japan. NUMEN™ Silk is appropriate for the embolization of small to mid-sized aneurysms, micro-sized aneurysms, and ruptured aneurysms. Its “3-D” and “Ω+S” structure gives superior compliance to irregular aneurysm walls, and it is available in a variety of diameters and lengths, providing more options for clinical application.
NUMEN™ Silk is a new generation, ultra-soft, electrolytically detachable coil system with extra-fine primary coil wires that ensures the softness of coils, helps to reduce the pressure on the aneurysm wall, and lowers the risk of aneurysm rupture during surgery. Meanwhile, the pusher of NUMEN™ Silk has an ultra-soft distal end that increases its flexibility, making it as soft as the coils. This, combined with the ultra-short detaching zone, helps to reduce kick-back effects during the procedure, and achieve a smooth filling, resulting in safer and more effective aneurysm embolization.
While the FDA approval represents an important milestone, the true significance of NUMEN™ Silk lies in its potential to transform hemorrhagic stroke treatment. NUMEN™ Silk underscore MicroPort NeuroScientific's commitment to providing clinicians with safer, more effective treatment options through continuous innovation.
About Coil Embolization:
Intracranial aneurysms, localized abnormal dilation of the cerebral artery walls that form aneurysmal bulges, are typically asymptomatic until rupture, which can cause high mortality and disability rates, thus being referred to as cerebral ticking bombs. Coil embolization is a common minimally invasive interventional surgical method for treating aneurysms. It employs metal coils delivered precisely to the aneurysm via an intravascular catheter, which are then released to fill the aneurysm sac, thus 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
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