Shape Memory Medical Receives FDA Clearance for the IMPEDE-FX Embolization Plug

Shape Memory Medical Inc. announced today it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the IMPEDE-FX Embolization Plug. The IMPEDE-FX Embolization Plug is an adjunct to the IMPEDE Embolization Plug which previously received 510(k) clearance by the FDA and is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE-FX is available in three sizes, with the maximum device having an expanded diameter of 12 mm.

Read the full announcement at Business Wire