www.fdanews.com/articles/191471-fda-clears-shape-memorys-embolization-plug
![ClearanceStamp_Orange.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Orange.gif?t=1609798625&width=430)
FDA Clears Shape Memory’s Embolization Plug
May 30, 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.