Terumo Neuro FREDX2513 FRED™ X, Flow Diverter Stent, 21 System, Flow Re-Direction Endoluminal Device 2.5mm X 13mm. Box of 01

Terumo Neuro FREDX2513 FRED™ X, Flow Diverter Stent, 21 System, Flow Re-Direction Endoluminal Device 2.5mm X 13mm. Box of 01

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.

• FRED X offers the same precise, predictable placement and immediate opening of the FRED™ device – now with X Technology
• X Technology creates an optimized, protective hydration layer that is designed to allow for selective attachment to the device surface. 
• Preclinical data shows that FRED X reduces material thrombogenicity while also maintaining the natural vessel healing response.
• FRED X also features a reduction in delivery and retraction forces for easier tracking through tortuous anatomies.

DEVICE DESCRIPTION

The Flow Re-Direction Endoluminal Device (FRED®) System [see Figures 1, 2] consists of a
self-expanding nickel titanium implant and a delivery system. The implant is designed to expand to a pre-determined diameter when released from the delivery system.

The implant features integrated dual layer coverage designed to focus mainly at the neck of an intracranial aneurysm.

The implant has distal and proximal markers on its ends and interweaved helical marker strands delineating the inner working length of the implant to provide fluoroscopic visibility.

The FRED® System is packaged sterile as a single unit with the implant, introducer sheath and a detachable delivery pusher.