Shape Memory Medical, a company out of Santa Clara, California, won FDA clearance for its IMPEDE-FX Embolization Plug. The new device is to be used as an adjunct to the firm’s IMPEDE Embolization Plug, which is already FDA cleared. The two devices have been developed to cause deliberate obstructions or to reduce blood flow in peripheral vessels.
The new IMPEDE-FX comes in three sizes, the largest of which has a diameter of 12 millimeters when fully expanded. It is made of a proprietary shape memory polymer that has its development roots at Lawrence Livermore National Lab and Texas A&M University. The material is a porous polymer that can expand after being squeezed inside a catheter. The plug resumes its original shape after leaving the catheter, which was “memorized” prior to delivery.
Both the IMPEDE and IMPEDE-FX embolization plugs have the European CE mark of approval and have already been used in Europe in a number of procedures.
Product page: IMPEDE-FX Embolization Plug
Via: Shape Memory Medical