Shape Memory Medical 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 devices, 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,” the company reported.
The MDR framework introduces significantly higher expectations for safety, risk management, postmarket surveillance and clinical evidence for medical devices seeking EU market access.
The Impede family includes the Impede embolization plug, Impede-FX plug and Impede-FX RapidFill.
Alongside newly certified peripheral vascular indications, Shape Memory Medical is seeking additional clinical applications through the AAA-SHAPE trial, a prospective, multicenter, randomized, open-label study evaluating the safety and effectiveness of the Impede-FX RapidFill device in 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.
The company is also 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.
