FDA Clears Shape Memory Medical's Impede Embolization Plug
June 26, 2018—Shape Memory Medical Inc. announced that it has received 510(k) clearance from the US Food and Drug Administration for its Impede embolization plug, which is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The device, which features the company's Shape Memory Polymer (SMP), is available in three sizes to treat vessels up to 10 mm in diameter.
The Impede embolization plug received European CE Mark approval in August 2017 and has been used to treat patients in New Zealand and in several countries in the European Union.
According to the company, the Impede device's SMP technology features porous polymeric materials capable of changing from a catheter-deliverable shape to a “memorized” larger conformable shape when delivered into a blood vessel. The company continues to develop SMP technology for an expanded range of clinical uses, including neurovascular applications.