Shape Memory Medical has announced CE mark approval for the Impede-FX RapidFill device, an expansion of the Impede family of biodegradable peripheral vascular embolisation plugs.
Ted Ruppel, president and CEO of Shape Memory Medical said, “We are excited to introduce Impede-FX RapidFill to the endovascular community in Europe. This is the first device on the market that enables the delivery of multiple embolisation plugs in a single application, which may provide an advantage in cases where the goal is to quickly fill and occlude large spaces such as aneurysms, venous insufficiency, or trauma with reduced procedure and fluoroscopy time, contrast media, and blood loss.”
The Impede family includes the Impede embolisation plug, the Impede-FX embolisation plug, and now Impede-FX RapidFill which consists of five Impede-FX-12 embolisation plugs preloaded into a single delivery introducer. This peripheral vascular platform incorporates the Company’s novel Shape Memory polymer technology, a porous, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood for rapid conversion to organised thrombus.
Preclinical and clinical studies have shown that Shape Memory Polymer offers effective and predictable space filling compared to traditional coils and plugs, stable clot formation for reduced intradevice recanalisation, and progressive, intradevice healing as the material biodegrades.
To date, nearly 600 patients have been treated worldwide with the Impede family of devices.