Use of a Flow Re-direction Endoluminal Device (FRED) for Wide-neck Large/Giant Cerebral Aneurysms

Abstract

Objective: There are some reports concerning the effectiveness of flow-diverter (FD) stents for untreatable cerebral aneurysm by conventional surgery and endovascular treatment. Treatment with a Pipeline embolization device, one of the original FD stents, has just started in Japan. We report herewith our initial experience of Flow Re-direction Endoluminal Device (FRED), which is a new FD with unique double layer structures, for wide-neck large or giant cerebral aneurysms. Materials and Methods:This report is part of a clinical trial for the approval of FRED in Japan with permission of the Institutional Review Board of Toranomon Hospital. Between October 2014 and January 2015, we treated six aneurysms in six patients with FRED including three cavernous and three paraclinoid aneurysms, three asymptomatic and three symptomatic aneurysms, four large and two giant aneurysms.Results: All patients were treated with single FRED without any coils. There were no transient ischemic attack, no stroke and no death in peri-and post-operative periods. One patient's preexisting eye symptom temporarily worsened. Followup angiography at 6 months showed no filling (O'Kelly Marotta scale: D) in two patients, entry remnant (OKM scale C) in two patients, and subtotal filling (OKM scale B) in two patients. Conclusion:Treatments using FRED were achieved without any severe complication. Clinical trials will continue to demonstrate its safety and efficacy for complex aneurysms.