Shape Memory Medical Announces Approvals for the IMPEDE Embolization Plug Product Family in Singapore and Malaysia

SAN JOSE, Calif.--(BUSINESS WIRE)--Shape Memory Medical Inc., the innovator of the only commercially available volume-expanding shape memory polymer for endovascular embolization applications, announced today that it has received approvals from both Singapore’s Health Science Authority (HSA) and Malaysia’s Medical Device Authority (MDA) to market the IMPEDE Embolization Plug, the IMPEDE-FX Embolization Plug, and the IMPEDE-FX RapidFill System. Getz Healthcare Pty Ltd, which is a member of the privately held Getz Group of Companies, has been instrumental in driving the approval process and serves as Shape Memory Medical’s distribution partner for its peripheral embolization portfolio.

“We are thrilled by these approvals, which create significant opportunities to accelerate our growth across key Asia Pacific markets,” said Ted Ruppel, President and CEO of Shape Memory Medical. “Following our initial launch in Japan with Cosmotec in 2019, and our expansion into Hong Kong and Taiwan with Getz Healthcare in 2023, we are now building on that momentum with market entry into Singapore and Malaysia. The IMPEDE family of bioabsorbable peripheral embolization plugs is a strong complement to Getz Healthcare’s existing endovascular portfolio, further strengthening our presence and commitment to the region.”

In Singapore and Malaysia, the IMPEDE Embolization Plug, IMPEDE-FX Embolization Plug, and IMPEDE-FX RapidFill System are indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE and IMPEDE-FX Embolization Plugs are available in three sizes, with the largest device offering an expanded diameter of 12 mm and an embolic volume capacity of 1.25 mL. Complementing this, the IMPEDE-FX RapidFill System delivers a maximum expanded embolic volume of 6.25 mL, providing physicians with versatile options to address a broad range of clinical needs.

The IMPEDE Embolization Plug family of devices utilizes Shape Memory Medical’s proprietary shape memory polymer—a porous, radiolucent embolic material that is crimped for catheter delivery and self-expands to its original shape upon exposure to the warm, aqueous environment of a blood vessel. This expansion forms a flexible, porous scaffold designed to promote consistent thrombus formation and enable rapid, durable occlusion throughout the device.

James Simkins, Getz Healthcare’s Chief Executive Officer, added, “With the launch of the novel shape memory polymer devices in Singapore and Malaysia, we are seeing strong momentum and positive engagement from the endovascular community. The addition of the IMPEDE Embolization Plug device family strengthens our focus on our pan vascular portfolio across the region and positions us to drive accelerated adoption, expand our market presence, and capture significant growth opportunities in embolization therapies.”

About GETZ Healthcare

Getz Healthcare is proud to be recognized as the leading distributor of medical equipment, devices and consumables, in Asia Pacific.

Getz Healthcare is an ISO 9001:2015 certified company, and partners with leading manufacturers in medical technology, to offer a wide range of innovative and high-quality products & solutions, enabling customers to focus on what’s important – providing better care for their patients.

Headquartered in Singapore, Getz Healthcare has been operating in the Asia region for over 110 years, serving over 7,500 customers, from 23 offices and distribution centers, spread across Australia, Hong Kong, Malaysia, New Zealand, Pakistan, Philippines, Taiwan, Thailand and Vietnam.

Getz Healthcare is part of The Getz Group of companies, with the mission to bring meaningful healthcare solutions to the people of Asia Pacific.

About Shape Memory Medical

Shape Memory Medical Inc. is a California-based, global medical device company dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers, with devices approved in more than 30 countries spanning regions in Asia, the Middle East, Europe, the Americas and Australia and over 3500 patients treated worldwide. The IMPEDE and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill are CE Mark approved. The IMPEDE and IMPEDE-FX Embolization Plugs are approved in Japan and cleared for use in the United States. 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. In the United States, IMPEDE-FX RapidFill is an investigational device, limited by Federal (or United States) law to investigational use. For more information, visit www.shapemem.com.