Fred™ 21 System Animation

Animation of the FRED® 21 Flow Re-Direction Endoluminal Device
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 greater than or equal to 4 mm or dome-to-neck ratio less than 2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter greater than or equal to 2.0 mm and less than or equal to 5.0 mm.
Use of the FRED® System is contraindicated under these circumstances: Patients in whom anticoagulant, anti-platelet therapy, or thrombolytic drugs are contraindicated; patients with known hypersensitivity to metal such as nickel-titanium and metal jewelry; patients with anatomy that does not permit passage or deployment of the FRED® System; patients with an active bacterial infection; patients with a pre-existing stent in place at the target aneurysm; patients in whom the parent vessel size does not fall within the indicated range; patients who have not received dual anti-platelet agents prior to the procedure.
For complete indications, contraindications, potential complications, warnings, precautions, and instructions, see instructions for use (IFU provided in the device).
Caution: Federal law restricts these devices to sale by or on the order of a physician.