FDA OKs Shape Memory Medical’s Impede Embolization Plug

Shape Memory Medical Inc. announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the IMPEDE Embolization Plug. The IMPEDE Embolization Plug is 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 IMPEDE Embolization Plug received CE marking in August 2017 and has been used to treat patients in New Zealand and in several EU countries. Commenting on this regulatory milestone and ongoing clinical usage, Shape Memory Medical’s president and CEO, Ted Ruppel, said, “The IMPEDE Embolization Plug is an exciting development in embolization technology, expanding the options open to physicians treating conditions requiring occlusion of the peripheral vasculature.” Speaking about IMPEDE, Dr. Jafar Golzarian, Radiologist with University of Minnesota Health stated, “It is exciting to see the approval of new developments in embolization technology, offering physicians a new alternative to embolization coils.”
 
The IMPEDE embolization devices feature proprietary Shape Memory Polymer (SMP) technology developed at Texas A&M University and Lawrence Livermore National Laboratory. Shape Memory Medical was founded to commercialize stable, predictable embolization solutions for a variety of clinical applications. The SMP technology includes 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. With both internally developed and licensed technologies, Shape Memory has 26 issued U.S. patents and multiple patents under review on a worldwide basis. This intellectual property includes the use of SMP for a variety of clinical applications.
 
Development was funded in part by the National Institutes of Health (National Institute of Biomedical Imaging and Bioengineering grants R43EB022016 and R44EB022016).