The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Impede-FX embolization plug (Shape Memory Medical). This device is available in three sizes, the largest having an expanded diameter of 12mm. 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 “memorised” larger, conformable shape when delivered into a blood vessel.
