FDA Clears Shape Memory Medical's Impede-FX Embolization Plug
June 11, 2019—Shape Memory Medical Inc. announced FDA 510(k) clearance for the Impede-FX embolization plug, which is available in three sizes, with the largest device having an expanded diameter of 12 mm. In 2018, the Impede-FX received CE Mark approval in Europe, where it has been available through a limited commercial release in Germany and the Netherlands.
According to Shape Memory Medical, the device is an adjunct to the company's Impede embolization plug, which previously received FDA clearance, and is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
The Impede product family features the company's Shape Memory Polymer (SMP) technology. SMP is a porous polymeric material capable of changing from a smaller, catheter-deliverable shape to a “memorized” larger, conformable shape when delivered into a blood vessel.