Shape Memory Medical said today it has received FDA 510(k) clearance for its Impede-FX embolization plug designed to obstruct or reduce the rate of blood flow in the peripheral vasculature.
The Impede-FX plug is an adjunct to the Santa Clara, Calif.-based company’s Impede embolization plug, which received 510(k) clearance in 2018. The newly cleared plug is available in three sizes, with the maximum device having an expanded diameter of 12mm. Impede-FX received the CE Mark in 2018.
“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,” said Shape Memory Medical president and CEO Ted Ruppel in a news release.
The 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 company said.