Shape Memory Medical secures EU MDR CE mark for embolisation plugs

Shape Memory Medical has received CE marking under the EU Medical Device Regulation (EU MDR) for its IMPEDE embolisation plug family, including Impede, Impede-FX, and the Impede RapidFill delivery cartridge, classified as Class III devices.

The US company’s plugs block blood flow in targeted arteries or veins. Impede and Impede-FX are porous scaffolds compressed for catheter delivery and self-expansion upon contact with blood. RapidFill allows deployment of five Impede-FX plugs in a single use, enabling rapid occlusion of large vessels while reducing procedure and fluoroscopy time.

Impede’s material allows high-volume filling without radial force and is radiolucent for clearer imaging. CEO Ted Ruppel noted that EU MDR certification reflects strong clinical evidence. Shape is conducting pivotal trials for RapidFill in abdominal aortic aneurysm treatment and plans the FLAGSHIP study for aortic dissection embolisation.

Impede is FDA-cleared; RapidFill is investigational in the US and cleared in Japan.

28-12-2025