Shape Memory Medical has received CE mark approval under the European Union (EU) Medical Device Regulation (MDR) for its Impede embolization plug product family.

The product family was previously CE-marked under the Medical Device Directive (MDD) and has now earned the more stringent EU MDR certification, which was gained well in advance of the 2027 compliance deadline for Class IIb implantable and Class III devices. The MDR framework introduces significantly higher expectations for safety, risk management, post-market surveillance, and clinical evidence for medical devices seeking EU market access.

“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 Impede embolization product family leverages a novel shape memory polymer designed to enable vessel thrombosis. The porous embolic scaffold is crimped for catheter-based delivery and self-expands on contact with blood to support rapid occlusion. Its material allows for high-volume filling without exerting radial force, and its radiolucent properties improve imaging clarity during procedures and follow-up assessments, the company said.

“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.

Shape Memory Medical is also pursuing further clinical applications through its 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 company is also preparing to begin 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.