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Medical Devices / Submissions and Approvals

FDA Clears Shape Memory’s Embolization Plug

May 31, 2019

Shape Memory Medical’s Impede FX embolization plug has received FDA clearance for obstructing or reducing the rate of blood flow in a patient’s peripheral vasculature.

The device is made of a biodegradable shape memory polymer plug with a proximal marker band, which expands from its crimped shape following deployment into a blood vessel. It differs from Shape Memory’s previously cleared Impede product in that it has no anchor coil.

Once the device expands inside a blood vessel, its scaffold design serves as a structure for quick, stable blood clot formation.

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