Shape Memory Medical’s Impede Embolization Plug Product Family Secures EU MDR Certification

December 22, 2025—Shape Memory Medical Inc. announced that its Impede embolization plug product family, which previously received CE Mark approval under the European Union (EU) Medical Device Directive 93/42/EEC, has received certification as a class III device under the more stringent EU Medical Device Regulation (MDR) 2017/745.

According to Shape Memory Medical, the Impede embolization plug product family—including the Impede embolization plug, Impede-FX embolization plug, and Impede-FX RapidFill—utilizes the company’s shape memory polymer designed to enable vessel thrombosis.

In addition to the newly certified peripheral vascular indications, Shape Memory Medical noted it is advancing clinical applications for abdominal aortic aneurysm (AAA) sac healing and prevention of expansion through its AAA-SHAPE trial.

The prospective, multicenter, randomized, open-label study is evaluating the safety and effectiveness of the Impede-FX RapidFill device in improving AAA sac behavior when used in conjunction with elective endovascular aneurysm repair, stated Shape Memory Medical.

In February 2025, the company announced the commencement of European enrollment in the trial, which is anticipated to be completed in 2026. The trial will enroll up to 180 patients with long-term follow-up extending to 5 years.

Along with EU MDR approvals, the Impede and Impede-FX embolization plugs are approved in Japan and cleared for use in the United States. The Impede-FX RapidFill is an investigational device in the United States, noted the company.