Japanese Approval Granted for Shape Memory’s IMPEDE-FX Embolization Plug

Shape Memory Medical Inc. is allowed to market its IMPEDE-FX Embolization Plug in Japan, having received the proper approval from the country’s Pharmaceuticals and Medical Devices Agency (PMDA).  

“We are excited about the opportunity this approval brings to the Japanese market to expand,” said Ted Ruppel, president and CEO of Shape Memory Medical. “The IMPEDE family of biodegradable peripheral vascular embolization plugs are a great complement to Cosmotec’s current endovascular product lines.”

The product will be distributed in Japan by Cosmotec, which is a group company of M3 Inc.  
 
The IMPEDE-FX Embolization Plug is indicated for use in Japan as an adjunct to devices such as stents, coils, and plugs, and the IMPEDE Embolization Plug which previously received PMDA approval in 2019. IMPEDE-FX is percutaneously deployed in an artery or vein for obstructing blood flow in abnormal blood vessels like arteriovenous malformation and fistula, aneurysms, bleeding by traumatic vascular injury, tumors, etc. except for intracranial and cardiac vessels. IMPEDE-FX is available in three sizes, with the maximum device having an expanded diameter of 12mm.
 
Kiyoshi Takesue, Cosmotec’s chairman, said, “Since the introduction of the IMPEDE family of devices in Japan, the reception by the endovascular community has been very positive. With the addition of IMPEDE-FX to our product portfolio, we expect to see continued adoption of this novel approach to embolization therapies.”
 
IMPEDE Embolization Plugs feature the proprietary 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. Pre-clinical and clinical studies have shown that Shape Memory Polymer offers effective and predictable space filling compared to traditional coils and plugs, stable clot formation for reduced intradevice recanalization, and progressive healing as the material biodegrades. To date, nearly 600 patients have been treated worldwide with the IMPEDE Embolization Plug family of devices.
 
COSMOTEC Co. Ltd., established in 1992, specializes in sales and consulting of medical devices focusing on cardiac surgery, general surgery and endovascular treatment. COSMOTEC has 98 percent market share of the institutions conducting cardiovascular surgery in Japan. COSMOTEC has offices in Tokyo, Sapporo, Sendai, Nagoya, Osaka, Okayama and Fukuoka across Japan.