Multicenter Experience with FRED Jr Flow Re-Direction Endoluminal Device for Intracranial Aneurysms in Small Arteries

Area of Science:

• Neurosurgery
• Endovascular Therapy
• Medical Devices

Background:

• Flow diverters offer an endovascular option for intracranial aneurysms.
• Treatment of aneurysms at and beyond the circle of Willis remains challenging.
• The Flow Re-Direction Endoluminal Device Jr (FRED Jr) is designed for small vessels (2.0-3.0 mm).

Purpose of the Study:

• To assess the clinical safety and efficacy of the FRED Jr device.
• To evaluate FRED Jr for treating intracranial aneurysms in small vessels.
• To determine occlusion rates and complication profiles of FRED Jr.

Main Methods:

• A multicenter observational clinical study involving 42 patients and 47 aneurysms.
• Treatment utilized a flow-direction technique with the FRED Jr device.
• Primary safety endpoints included absence of death, major/minor stroke, and TIA; efficacy endpoints were complete/near-complete occlusion at 1, 6, and 12 months.

Main Results:

• Technical success was achieved in all FRED Jr deployments.
• The primary safety endpoint was met in 93% of patients; minor complications included one TIA and two strokes.
• High occlusion rates were observed: 66% at 1 month, 78% at 6 months, and 100% at 12 months.

Conclusions:

• The FRED Jr device demonstrates safety and effectiveness for intracranial aneurysms in small vessels.
• Flow diversion with FRED Jr is a viable endovascular treatment option for these challenging aneurysms.
• The study supports the use of FRED Jr in its intended small-vessel indication.