Flow Re-Direction Endoluminal Device, MicroVention – Sim&Size v1.1.2
Indication for use (P180027)
The Flow Re-Direction Endoluminal Device (FRED) System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment of adult patients (22 years of age or older) with wide-necked (neck width 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter 2.0 mm and ≤ 5.0 mm.