Shape Memory Medical Gains 510(k) Clearance

June 26, 2018

Shape Memory Medical’s Impede embolization plug gained 510(k) clearance from the FDA for use in obstructing the rate of blood flow in the peripheral vasculature.

The device, used for treating conditions that require blockage of the peripheral vasculature, is available in three sizes to treat vessels up to 10mm in diameter.

The plug features porous materials that can change from a catheter-deliverable shape to a larger, memorized shape.

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