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March 23, 2021
Shape Memory Medical’s Impede-FX Embolization Plug Approved in Japan
March 23, 2021—Shape Memory Medical Inc. announced that it has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to market its Impede-FX embolization plug in Japan.
According to the company, the Impede-FX embolization plug is indicated for use in Japan as an adjunct to devices such as stents, coils, and plugs, as well as the Impede embolization plug that received PMDA approval in 2019.
Impede-FX is percutaneously deployed in an artery or vein for obstructing blood flow in abnormal blood vessels such as arteriovenous malformation and fistula, aneurysms, bleeding by traumatic vascular injury, and tumors. It is not used in intracranial and cardiac vessels. Impede-FX is available in three sizes, with the maximum device having an expanded diameter of 12 mm.
Impede embolization plugs feature the Shape Memory Polymer technology, a porous, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood for rapid conversion to organized thrombus, stated the company.
Cosmotec, which is a Group Company of M3 Inc., facilitated the approval process in Japan. Cosmotec is Shape Memory Medical’s distribution partner for its peripheral embolization products.
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