December 2, 2019
Shape Memory Medical’s Impede Embolization Plug Family Approved in Japan
December 2, 2019—Shape Memory Medical Inc. announced that the company’s Impede embolization plugs have been approved in Japan by the Pharmaceuticals and Medical Devices Agency. Cosmotec, a group company of M3 Inc., facilitated the approval process in Japan and is Shape Memory Medical’s distribution partner for all its peripheral embolization products.
The Impede embolization plugs are indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. It is available in three sizes to treat vessels up to 10 mm in diameter. The device features the company’s shape memory polymer (SMP) technology.
According to the company, the SMP technology is a porous polymeric material capable of changing from a smaller, catheter-deliverable shape to a “memorized” larger, conformable shape in response to the body when implanted. The company continues to develop materials and therapies, including products for neurovascular as well as peripheral vascular applications.
Shape Memory Medical has received FDA clearance and European CE Mark approval for the Impede and Impede FX devices for peripheral embolization applications. Additionally, the company’s Trellix embolic coil has CE Mark approval for neurovascular applications; it is not cleared or approved by FDA or commercially available in the United States.