Shape Memory Medical Secures EU MDR Certification for IMPEDE® Embolization Plug Product Family, Accelerating Global Innovation in Vascular Care

SAN JOSE, Calif.--(BUSINESS WIRE)--Shape Memory Medical Inc., innovator of the proprietary shape memory polymer technology for endovascular applications, announced that its IMPEDE® Embolization Plug product family has received certification as a Class III device under the European Union (EU) Medical Device Regulation (MDR) 2017/745. The IMPEDE Embolization Plug family, previously CE-marked under the Medical Device Directive 93/42/EEC (MDD), has now earned the more stringent EU MDR certification—achieved well in advance of the 2027 compliance deadline for Class IIb implantable and Class III devices.

“Securing MDR CE Mark certification for the IMPEDE platform is a major milestone in our commitment to advancing breakthrough therapies for endovascular disease,” said Ted Ruppel, President and CEO of Shape Memory Medical. “It recognizes both the strength of our clinical data and the dedication of our global clinical partners.”

The MDR framework introduces significantly higher expectations for safety, risk management, post-market surveillance, and clinical evidence for medical devices seeking EU market access. “The IMPEDE Embolization Plug family’s clinical and real-world experience was central to the platform’s successful review. Achieving MDR certification ensures long-term access to Europe’s largest healthcare systems and reinforces physician confidence in the device family’s performance, consistency, and traceability,” continued Ruppel.

The IMPEDE Embolization Plug product family—including the IMPEDE Embolization Plug, IMPEDE-FX® Embolization Plug, and IMPEDE-FX® RapidFill—utilizes a novel shape memory polymer designed to enable vessel thrombosis. This porous embolic scaffold is crimped for catheter-based delivery and self-expands upon contact with blood, supporting rapid occlusion. Its soft, conformable material allows for high-volume filling without exerting radial force, while its radiolucent properties improve imaging clarity during procedures and follow-up assessments.

Alongside its newly certified peripheral vascular indications, Shape Memory Medical is advancing additional clinical applications through its landmark AAA-SHAPE trial – Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion. This prospective, multicenter, randomized, open-label study is evaluating the safety and effectiveness of the IMPEDE-FX RapidFill® Device in improving abdominal aortic aneurysm (AAA) sac behavior when used in conjunction with elective endovascular aneurysm repair (EVAR). The trial will enroll up to 180 patients with long-term follow-up extending to five years. Enrollment is anticipated to be completed in 2026. In parallel, the company is preparing to initiate FLAGSHIP, a first-in-human study to evaluate a next generation, large-diameter shape memory polymer system engineered specifically for false lumen embolization in aortic dissection—further expanding the potential of its platform in aortic care.

About Shape Memory Medical

Shape Memory Medical is a California-based, global medical device company focused on innovative therapeutic solutions using shape memory polymer technology. With commercialized devices in the embolization space, the company is actively leveraging its platform technology to develop novel applications for the management of complex aortic pathologies.

Alongside EU MDR approvals, 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.