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Medical Devices / Submissions and Approvals

FDA Clears Shape Memory’s Embolization Plug

May 31, 2019
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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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