March 10, 2021

Shape Memory Medical’s Impede-FX RapidFill Device Receives CE Mark Approval

March 10, 2021—Shape Memory Medical Inc. announced European CE Mark approval for the Impede-FX RapidFill device, an expansion of the company’s Impede family of biodegradable peripheral vascular embolization plugs.

According to the company, the peripheral vascular platform incorporates the Shape Memory polymer technology, a porous, embolic scaffold that is crimped for catheter delivery and self-expands on contact with blood for rapid conversion to organized thrombus. RapidFill consists of five Impede-FX-12 embolization plugs preloaded into a single delivery introducer.

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 recanalization, and progressive intradevice healing as the material biodegrades, stated the company.

Impede-FX RapidFill is not cleared for use and is not available for sale in the United States, advised Shape Memory Medical.

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March 10, 2021

Shape Memory Medical’s Impede-FX RapidFill Device Receives CE Mark Approval

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