Shape Memory Medical Inc., the developer of proprietary volume-expanding shape memory polymer solutions for endovascular embolization, today announced that Brazil’s national health surveillance agency, ANVISA (Agência Nacional de Vigilância Sanitária), has granted authorization for the IMPEDE Embolization Plug, the IMPEDE-FX Embolization Plug, and the IMPEDE-FX RapidFill. The approval process was supported by Biomedical, which acts as Shape Memory Medical’s Brazilian registration holder (BRH) for its peripheral embolization product line.

“Brazil represents one of the largest and fastest-growing endovascular markets in Latin America, with an estimated 30,000 embolization procedures performed annually and projected market growth exceeding 10%, making this an important milestone for Shape Memory Medical,” said Ted Ruppel, President and CEO of Shape Memory Medical. “Together with Biomedical, we look forward to bringing our novel shape memory polymer solution to physicians treating peripheral vascular disease while continuing to expand our presence in the region.”

In Brazil, the IMPEDE Embolization Plug, IMPEDE-FX Embolization Plug, and IMPEDE-FX RapidFill 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. Further enhancing the portfolio, the IMPEDE-FX RapidFill offers up to 6.25 mL of expanded embolic volume, providing a versatile solution for embolization procedures across a wide range of peripheral vessels, helping physicians meet evolving clinical demands. Multiple peer-reviewed studies have demonstrated the safety and effectiveness of the company’s shape memory polymer solutions in peripheral embolization.

The IMPEDE Embolization Plug product family incorporates Shape Memory Medical’s novel shape memory polymer, a radiolucent and highly porous material designed for catheter-based delivery. Once delivered through a standard catheter, the polymer expands upon exposure to body temperature and blood, returning to its pre-set shape. This process creates a conformable scaffold that encourages thrombus formation without exerting untoward radial force on vasculature and supports efficient, long-lasting vessel occlusion.

“We have already seen strong interest from Brazil’s endovascular community as we prepare to introduce this innovative shape memory polymer technology,” said Bernardo Machado, Chief Executive Officer of Biomedical. “Adding the IMPEDE product family enhances our vascular portfolio, helping us broaden our footprint and growth opportunities within the embolization therapy space.”

About Biomedical

Founded in 1984 in Brazil, Biomedical is dedicated to delivering high-quality medical devices across multiple specialties, including vascular and endovascular surgery, interventional radiology, interventional cardiology, and intensive care. The company offers a portfolio of more than 35 products and maintains ISO 9001:2015 certification. By partnering with leading global manufacturers, Biomedical provides innovative solutions that enable healthcare providers to focus on delivering optimal patient care.

For more information, visit www.biomedical.com.br.

About Shape Memory Medical

Shape Memory Medical Inc. is a California-based medical device company focused on advancing therapeutic solutions through its proprietary shape memory polymer technology. The company has secured approvals in more than 40 countries across Asia, the Middle East, Europe, the Americas, and Australia, and over 3,500 patients have been treated worldwide. It continues to expand its platform applications to develop novel applications for the management of complex aortic pathologies.

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 about Shape Memory Medical, visit www.shapemem.com.

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