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.
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