Shape Memory Medical Receives ANVISA Authorization for IMPEDE Embolization Plug Portfolio in Brazil
Shape Memory Medical Inc., a medical technology company developing volume-expanding shape memory polymer solutions for endovascular embolization, has announced that Brazil’s national health surveillance agency, Agência Nacional de Vigilância Sanitária (ANVISA), has authorized the company’s IMPEDE Embolization Plug, IMPEDE-FX Embolization Plug, and IMPEDE-FX RapidFill for use in the Brazilian market.
The regulatory milestone expands the availability of Shape Memory Medical’s peripheral embolization technology in one of Latin America’s largest and fastest-growing endovascular markets. The authorization was supported by Biomedical, which serves as Shape Memory Medical’s Brazilian registration holder (BRH) for its peripheral embolization product portfolio.
The ANVISA authorization provides Shape Memory Medical with an opportunity to broaden access to its shape memory polymer technology among physicians performing peripheral embolization procedures in Brazil. The company said the launch is expected to strengthen its presence in the region while adding a differentiated technology platform to the country’s vascular intervention market.
“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.”
Expansion Into Brazil’s Peripheral Embolization Market
Peripheral embolization is an important endovascular intervention used to intentionally obstruct or reduce blood flow within targeted blood vessels. Depending on the clinical setting, embolization can be used to manage a variety of vascular conditions and to support procedures in which controlled vessel occlusion is required.
The introduction of the IMPEDE product family in Brazil is designed to provide physicians with additional options for achieving vessel occlusion through a catheter-based approach. Shape Memory Medical’s technology is based on a proprietary shape memory polymer that is designed to expand after deployment, creating an embolic structure within the targeted vessel.
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 offered in three sizes. The largest device has an expanded diameter of up to 12 millimeters and an embolic volume capacity of 1.25 milliliters. This range is intended to provide physicians with flexibility when selecting an embolization device based on vessel anatomy and procedural requirements.
The portfolio is further expanded by the IMPEDE-FX RapidFill, which can provide up to 6.25 milliliters of expanded embolic volume. According to Shape Memory Medical, the device is designed to provide a versatile option for embolization procedures involving a broad range of peripheral vessels.
The availability of multiple device configurations may help physicians tailor embolization procedures to different vessel sizes and clinical requirements. The company believes this flexibility can be particularly valuable as physicians manage increasingly diverse peripheral vascular interventions.
Shape Memory Polymer Technology
At the core of the IMPEDE product family is Shape Memory Medical’s proprietary shape memory polymer technology. The material is designed specifically for catheter-based delivery and combines a radiolucent structure with high porosity and volume-expanding characteristics.
The devices are delivered through a standard catheter to the targeted vascular location. Following deployment, the polymer is exposed to the patient’s body temperature and blood, which causes it to expand and return toward its predetermined shape.
This expansion mechanism allows the device to create a conformable scaffold within the vessel. The scaffold is designed to promote thrombus formation and facilitate vessel occlusion while avoiding excessive radial force against the vessel wall.
The company said this approach differentiates its technology from conventional embolization solutions and is intended to support controlled and durable vessel occlusion.
The polymer’s porous structure is also an important component of the technology. By providing a framework for thrombus formation, the device is designed to encourage the body’s natural clotting process following deployment.
Because the material expands after delivery, the technology can be compressed during catheter-based placement and subsequently recover its designed configuration within the vessel. This allows the embolic material to be delivered through a catheter while providing a larger expanded volume after deployment.
Designed for Peripheral Vascular Applications
The IMPEDE family has been developed for applications within the peripheral vasculature, where physicians may need to selectively reduce or stop blood flow in targeted vessels.
Peripheral embolization procedures can involve different vessel sizes and anatomical locations, requiring devices that offer appropriate dimensions and embolic volume. Shape Memory Medical’s product range is intended to address these requirements through different device sizes and configurations.
The company said the IMPEDE-FX RapidFill further extends the platform by providing substantially greater expanded embolic volume than the standard IMPEDE and IMPEDE-FX Embolization Plugs. With up to 6.25 milliliters of expanded embolic volume, the device is designed to provide physicians with another option when larger embolic volumes are required.
The portfolio’s catheter-based delivery system is also intended to integrate into established endovascular workflows. Physicians can deliver the devices through standard catheter techniques, potentially allowing the technology to be incorporated into existing peripheral embolization procedures.
Multiple peer-reviewed studies have evaluated Shape Memory Medical’s shape memory polymer solutions in peripheral embolization. The company said published evidence has demonstrated the safety and effectiveness of its technology in these applications.
Biomedical Supports Brazilian Market Entry
The ANVISA authorization was supported by Biomedical, Shape Memory Medical’s Brazilian registration holder for its peripheral embolization product line.
As the company prepares to introduce the IMPEDE family in Brazil, the partnership with Biomedical is expected to play an important role in supporting the commercialization and regional expansion of the technology.
Brazil has a substantial healthcare market and a growing interventional vascular sector. The country’s expanding demand for endovascular procedures provides an important commercial opportunity for companies developing minimally invasive technologies.
Bernardo Machado, Chief Executive Officer of Biomedical, said the company has already observed significant interest from Brazil’s endovascular community as the IMPEDE technology moves toward market introduction.
“We have already seen strong interest from Brazil’s endovascular community as we prepare to introduce this innovative shape memory polymer technology,” said Machado. “Adding the IMPEDE product family enhances our vascular portfolio, helping us broaden our footprint and growth opportunities within the embolization therapy space.”
The partnership will therefore combine Shape Memory Medical’s embolization technology with Biomedical’s presence in the Brazilian medical device market. The companies expect the collaboration to support access to the IMPEDE portfolio among physicians treating peripheral vascular conditions.
Regulatory Authorization Strengthens Regional Expansion
The Brazilian authorization represents another step in Shape Memory Medical’s broader strategy to expand the geographic reach of its shape memory polymer platform.
Regulatory clearances and market authorizations are particularly important for medical device companies seeking to introduce specialized endovascular technologies into new healthcare systems. ANVISA authorization enables Shape Memory Medical and Biomedical to move forward with the commercialization of the IMPEDE product family in Brazil, subject to applicable market requirements.
The company views Brazil as a strategically important market because of its established endovascular infrastructure, large patient population and expected growth in vascular intervention procedures.
With an estimated 30,000 embolization procedures performed annually in Brazil and projected market growth of more than 10%, Shape Memory Medical sees significant potential for its technology in the country. The company expects the launch to contribute to its efforts to establish a stronger presence across Latin America.
The regulatory milestone also highlights the growing role of minimally invasive technologies in the treatment of vascular disease. As physicians continue to seek embolization solutions that can be delivered through catheter-based techniques while providing controlled and durable occlusion, technologies designed to improve procedural flexibility may have increasing relevance.
Broadening Options for Endovascular Physicians
The IMPEDE product family provides physicians with a portfolio of embolization devices designed around a common shape memory polymer platform. The combination of different sizes, expanded embolic volumes and catheter-based delivery is intended to address a variety of peripheral vascular applications.
The largest IMPEDE and IMPEDE-FX devices can achieve an expanded diameter of 12 millimeters and provide an embolic volume capacity of 1.25 milliliters, while the IMPEDE-FX RapidFill offers up to 6.25 milliliters of expanded embolic volume.
The devices’ ability to expand after deployment is central to the company’s approach. The polymer can be delivered in a compressed configuration and subsequently expands when exposed to body temperature and blood. The resulting porous scaffold is intended to facilitate thrombus formation and support vessel occlusion.
Shape Memory Medical believes the technology can provide an alternative approach for physicians performing peripheral embolization procedures, particularly where conformability, embolic volume and controlled vessel occlusion are important considerations.
With ANVISA authorization now secured, Shape Memory Medical and Biomedical can focus on introducing the technology to Brazilian physicians and expanding awareness of the IMPEDE platform.
The company said the milestone is consistent with its broader objective of making its shape memory polymer technology available to physicians treating peripheral vascular disease in additional markets. Through its collaboration with Biomedical, Shape Memory Medical expects to build on interest from Brazil’s endovascular community and establish new growth opportunities in the country’s embolization therapy market.
Overall, the ANVISA authorization marks a significant regulatory and commercial milestone for Shape Memory Medical, expanding the availability of its IMPEDE Embolization Plug family to Brazil. The approval of the IMPEDE Embolization Plug, IMPEDE-FX Embolization Plug and IMPEDE-FX RapidFill adds a new portfolio of shape memory polymer-based solutions for peripheral vascular embolization and provides the company with a foundation for further growth in Latin America.
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 investigative device, limited by Federal (or United States) law to investigative use.