Shape Memory Medical Receives PMDA Approval for the IMPEDE-FX Embolization Plug

SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc. announced today that it has received approval from Japan�s Pharmaceuticals and Medical Devices Agency (PMDA) to market its IMPEDE®-FX Embolization Plug in Japan. Cosmotec, which is a Group Company of M3 Inc https://corporate.m3.com/en/ listed on the Tokyo Stock Exchange (TYO:2413), championed the approval process in Japan and is Shape Memory Medical’s distribution partner for its peripheral embolization products.

“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 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, added, “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.

About COSMOTEC

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% market share of the institutions conducting cardiovascular surgery in Japan. COSMOTEC has offices in Tokyo, Sapporo, Sendai, Nagoya, Osaka, Okayama and Fukuoka across Japan. COSMOTEC is an M3, Inc., group company. Please visit http://cosmotec.com/english/ for more information.

About Shape Memory Medical

Shape Memory Medical Inc. is dedicated to developing innovative therapeutic solutions with its proprietary Shape Memory Polymers. Neurovascular embolization products include the TrelliX® Embolic Coil; CE marked for use in the EU. Peripheral embolization products include the IMPEDE and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill™ Device. In countries recognizing CE marking, the IMPEDE and IMPEDE-FX Embolization Plugs and the IMPEDE-FX RapidFill are indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. In the United States, the IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature, and the IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. For more information, visit www.shapemem.com.

Contacts

Shape Memory Medical Inc.

Mary Dennehy, VP Marketing

info@shapemem.com

Cosmotec Co. Ltd.

cosmotec.com