Device Dossier

FRED X Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial

Device Dossier for FRED X Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial (Stent, vascular, intracranial, Class III, sponsor Life…

Intended purpose

The FRED X System is intended for endovascular embolization of intracranial neurovascular aneurysms. The FRED X System may also be used with embolic coils for the treatment of intracranial neurovascular lesions.

Functional description

The FRED X System includes: A self-expanding, single wire braid, closed-cell, surface treated nitinol stent. An integrated dual layer construct designed to focus mainly at the neck of an aneurysm. Radiopaque markers on its proximal and distal ends as well as interwoven helical marker strands delineating the inner working length of the stent to provide fluoroscopic visibility.

TGA Public Summary