Shanghai, China, 8 February 2022 — MicroPort NeuroTech Limited (MicroPort NeuroTech™) has received marketing approval from China’s National Medical Products Administration (NMPA) for its independently-developed NUMEN Silk® 3-D Electronically Detachable Coil Embolization System (NUMEN Silk®).
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. NUMEN Silk® is intended for the embolization of small to mid-sized aneurysms, micro-sized aneurysms, and ruptured aneurysms. Its 3-D 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.
The pusher of NUMEN Silk® has a 15mm 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.
NUMEN Silk® is an upgraded version of the company’s NUMEN® Coil Embolization System (NUMEN®), which received marketing approval in China in September 2020, and has also received overseas certifications, including MFDS approval in South Korea, CE Marking in the European Union, and FDA approval in the United States. Well recognized for its efficacy by doctors globally, NUMEN® has been applied in numerous clinical implantations outside China.
Intracranial aneurysms most commonly occur at branch points of major cerebral arteries and their bifurcation, where the arterial wall is weak and subject to high blood impact. Over time, the weak spot gradually extends outwards to form an aneurysm, due to long-term blood pressure and impact. The incidence rate of aneurysm rupture increases over time, and when an aneurysm does rupture, the chances of mortality and disability are exceedingly high. Embolization of a cerebral aneurysm is performed using a minimally invasive approach in which coils are inserted into the aneurysm to form a clot, inhibiting blood flow and reducing intra-aneurysm pressure, thereby reducing the likelihood of aneurysm rupture.
The approval of NUMEN Silk® in China demonstrates MicroPort NeuroTech™’s capacity to iterate and improve products quickly, resulting in safer and more effective therapeutic options for hemorrhagic stroke treatment.