FDAnews
www.fdanews.com/articles/201803-shape-memory-obtains-ce-mark-for-embolization-plug-system
CE mark

Shape Memory Obtains CE Mark for Embolization Plug System

March 12, 2021

Shape Memory has received CE mark certification for IMPEDE-FX RapidFill, a device that delivers multiple embolization plugs.

The device, which is used to obstruct or reduce the rate of blood flow in a patient’s peripheral vasculature, consists of five IMPEDE-FX-12 embolization plugs that are preloaded into a single delivery introducer.

The RapidFill system uses the company’s Shape Memory Polymer technology, a porous scaffold that is crimped for catheter delivery and expands upon contact with blood to rapidly clot it.

View today's stories