FRED™ X Indications, Safety, and Warnings
See Instructions for Use for a complete list of warnings, precautions, and contraindications
Indications for Use
USA
The FRED™ X 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.
CANADA
The FRED™ X System is indicated for use with or without embolic coils for the treatment of intracranial aneurysms that are not amenable to treatment with surgical clipping with parent vessels that are ≥ 2.0 mm and ≤ 5.0 mm in diameter.
EMEA and CHAPLA
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.
Asian Markets: The products may not be approved in all regions. The orders will be taken only in the regions where the product is approved by local regulatory authorities, as required.
