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Polyurethane-based shape-memory foam embolization system cleared by FDA

July 20, 2018 / Norbert Sparrow

Shape Memory Medical (Santa Clara, CA) recently received FDA clearance to market its Impede Embolization Plug in the United States. The device is based on shape-memory polymer (SMP) technology and is designed to reduce or obstruct the rate of blood flow in the vasculature. Cleared for use in countries in Europe and elsewhere that recognize the CE mark in 2017, the technology is described as a new approach to embolization—inducing or creating a blood clot—by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), which funded the technology. The NBIB is part of the National Institutes of Health.