Shape Memory Medical has announced that Brazil’s national health surveillance agency, ANVISA (Agência Nacional de Vigilância Sanitária), has granted authorization for the Impede embolisation plug, the Impede-FX embolisation plug, and the Impede-FX RapidFill. The approval process was supported by Biomedical, which acts as Shape Memory Medical’s Brazilian registration holder for its peripheral embolisation product line.
“Brazil represents one of the largest and fastest-growing endovascular markets in Latin America, with an estimated 30,000 embolisation 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 the company. “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.”
A press release notes that, in Brazil, the Impede embolisation plug, Impede-FX embolisation 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 embolisation plugs are available in three sizes, with the largest device offering an expanded diameter of 12mm and an embolic volume capacity of 1.25mL.
The Impede-FX RapidFill offers up to 6.25mL of expanded embolic volume, which provides a “versatile solution” for embolisation procedures across a wide range of peripheral vessels, according to Shape Memory.
The company adds that multiple peer-reviewed studies have demonstrated the safety and effectiveness of the company’s shape memory polymer solutions in peripheral embolisation.
The Impede embolisation 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. Shape Memory details that 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, CEO of Biomedical. “Adding the Impede product family enhances our vascular portfolio, helping us broaden our footprint and growth opportunities within the embolization therapy space.”
