Shape Memory Medical Receives PMDA Approval for the IMPEDE® Embolization Plug Family

SANTA CLARA, Calif.

Shape Memory Medical Inc. announced today that its IMPEDE® Embolization Plugs have been approved in Japan by the Pharmaceuticals and Medical Devices Agency (PMDA). 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 all of its peripheral embolization products. The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. It is available in three sizes, to treat vessels up to 10 mm in diameter. IMPEDE Embolization Plugs feature proprietary shape memory polymer (SMP) technology.

Commenting on this regulatory approval, Shape Memory Medical’s President and CEO, Ted Ruppel, said, “We are excited to receive PMDA Approval for our IMPEDE Embolization Plugs. We have seen increased adoption in the EU and US markets and look forward to Cosmotec adding this to their product portfolio. The IMPEDE Embolization Plugs are a great complement to Cosmotec’s current endovascular product lines.”

Kiyoshi Takesue, Cosmotec’s President, added, “We are very excited to launch IMPEDE Embolization Plugs in the Japanese market. We are confident that this product will have a significant impact on the Japanese market. We are looking forward to providing this new type of embolization devices in partnership with Shape Memory Medical.”

IMPEDE Embolization Plugs contain proprietary Shape Memory Polymer (SMP) technology. SMP technology was initially researched and developed at Lawrence Livermore National Laboratory and Texas A&M University. Shape Memory Medical was founded to develop and commercialize solutions for a variety of clinical applications using this novel technology. The SMP technology is a porous polymeric material capable of changing from a smaller, catheter-deliverable shape to a “memorized” larger, conformable shape in response to the body when implanted. The company continues to develop innovative materials and therapies, including products for neurovascular as well as peripheral vascular applications.

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., based in Santa Clara, California, is committed to developing multiple medical therapies with their novel shape memory polymers. Products include CE Marked and FDA Cleared IMPEDE® and IMPEDE® FX devices for peripheral embolization applications, and the CE Marked TrelliX® Embolic Coil for neurovascular applications. The company’s TrelliX® Embolic Coils have not been cleared or approved by FDA, and are not commercially available in the United States. For more information, visit www.shapemem.com.

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