Shape Memory Medical’s embolisation plugs gain CE mark under EU MDR

Shape Memory Medical’s IMPEDE embolisation plug range has received CE mark as a Class III device under the European Union’s Medical Device Regulation (EU MDR).

The US company’s embolisation plugs are used to intentionally stop blood flow in a targeted artery or vein during vascular procedures. Impede and Impede-FX are porous embolic scaffolds that are crimped for catheter-based delivery and self-expand upon contact with blood. Meanwhile, Impede RapidFill is a cartridge that allows for five Impede-FX embolisation plugs to be introduced in a single application with the aim to quickly fill and occlude large vessels or lesions with reduced procedure and fluoroscopy time.

According to Shape, the nature of Impede’s material allows for high-volume filling without exerting radial force, while its radiolucent properties aim to improve imaging clarity during procedures and follow-up assessments.

Sign up for Blog Updates