SANTA CLARA, Calif.--(BUSINESS WIRE)--Shape Memory Medical Inc. announced today it has received 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 previously received 510(k) clearance by FDA and is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE-FX is available in three sizes, with the maximum device having an expanded diameter of 12mm.
The IMPEDE-FX Embolization Plug received CE marking in 2018 and has been used to treat patients in several EU countries. Commenting on this regulatory approval and ongoing clinical usage, Shape Memory Medical’s 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.”
IMPEDE Embolization Plug has been used in nearly 100 cases worldwide, and IMPEDE-FX has been used in Germany and the Netherlands during its limited release.
The IMPEDE product family features a proprietary Shape Memory Polymer (SMP) technology. This SMP technology was initially developed at Lawrence Livermore National Laboratory and Texas A&M University, and then at Shape Memory Medical, which was founded to commercialize stable, predictable embolization solutions for a variety of clinical applications. The SMP technology is a porous polymeric material capable of changing from a smaller, catheter-deliverable shape to a “memorized” larger, conformable shape when delivered into a blood vessel. The company continues to develop innovative materials, processes and applications, including neurovascular applications. Shape Memory has licenses to 30 issued patents for its Shape Memory technology, as well as 40 patent applications in process.
About Shape Memory Medical
Shape Memory Medical Inc., based in Santa Clara, California, is committed to developing multiple medical therapies with their novel Shape Memory Polymers. Some of these products include IMPEDE® and IMPEDE® FX devices for peripheral embolization applications, and the TrelliX® Embolic Coil for neurovascular applications. The company’s TrelliX® Embolic Coils have not been cleared or approved by FDA, and are not commercially available in the United States. For more information, visit www.shapemem.com