Shape Memory Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Impede-FX embolization plug.
The Impede-FX embolization plug is an adjunct to the Impede embolization plug, which earlier secured 510(k) clearance to obstruct or decrease the rate of blood flow in the peripheral vasculature.
Available in three sizes, the Impede-X device is provided with an expanded diameter of 12mm. In 2018, the company secured CE mark approval for the Impede-FX plug to market in the European Union region.
According to the company, the Impede embolization plug has been used in around 100 cases across the world, while Impede-FX has been used in Germany and the Netherlands during its limited release.
Impede product family is integrated with and advanced Shape Memory Polymer (SMP) technology, which was initially developed at Lawrence Livermore National Laboratory and Texas A&M University.
Later, Shape Memory Medical was established for the commercialization of stable and predictable embolization solutions for a variety of clinical applications.
The SMP technology is a porous polymeric material, which holds capacity to change from a smaller and catheter-deliverable shape to a memorized larger, conformable shape when delivered into a blood vessel.
The firm continuously focuses on the development of advanced materials, processes and applications, including neurovascular applications. It has licenses to 30 issued patents for its Shape Memory technology, as well as 40 patent applications in process.
Shape Memory Medical president and CEO, Ted Ruppel said: “The IMPEDE-FX Embolization Plug is a valuable expansion to our IMPEDE product family offerings, allowing physicians to embolize in greater lengths with minimal radiographic artifacts.”
Based in Santa Clara of California, Shape Memory Medical is involved in the development of multiple medical therapies with their novel Shape Memory Polymers.
The company produces Impede and Impede FX devices for peripheral embolization applications, and the TrelliX embolic coil for neurovascular applications.
TrelliX embolic coils have not yet secured approval from the FDA, and are not commercially available in the US.