Shape Memory Medical said today it won FDA 510(k) clearance for its Impede embolization plug designed to obstruct or reduce the rate of blood flow in the peripheral vasculature.
The newly cleared device, which won CE Mark approval last August, is available in three sizes and is intended to treat vessels up to 10 mm in diameter.
The Impede device features shape memory polymer technology developed at Texas A&M University and the Lawrence Livermore National Laboratory, the Santa Clara, Calif.-based company 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,” prez & CEO Ted Ruppel said in a press release.
“It is exciting to see the approval of new developments in embolization technology, offering physicians a new alternative to embolization coils,” Jafar Golzarian of University of Minnesota Health said in a prepared statement.
Last August, Shape Memory medical said it raised $7 million in a new round of equity financing.