Initial experience with implantation of novel dual layer flow-diverter device FRED.

Abstract

Flow-diverting stents can help treat complex and wide-necked cerebral aneurysms. The aim of the study was to evaluate initial experiences related to the safety and effectiveness of eight aneurysms treated with a new dual layer coverage designed flow-diverter device. In 2012 Fred flow-diverter devices were used to treat 8 unruptured wide neck (dome-neck ratio ≤ 1.5) and sidewall aneurysms in 6 patients. All aneurysms were located in the anterior circulation on the internal carotid artery (ICA). In 4 larger aneurysms (> 10 mm) one 3D coil in association with Fred was used to reduce potential incidence of postoperative subarachnoid haemorrhage (SAH). Dual antiplatelet therapy was administered before the procedure and continued for 3 months after it. Clinical parameters, aneurysm features and 3-month follow-up angiograms are presented. All 6 patients with 8 aneurysms were successfully stented with the Fred flow-diverter device and were discharged in generally good condition on dual-antiplatelet therapy. No complications were related to the procedure. In 5 cases digital subtraction angiography (DSA) control examination was performed after 3 months, showing complete occlusion of the aneurysms with patency of the parent artery. In 1 case thrombosis of the Fred occurred but without any clinical consequences because of cross-flow from the other side. Use of the Fred flow-diverter device was efficacious in all 8 treated cerebral aneurysms. The system seems to be promising as a flow diverter with certain characteristics, which allow for easy delivery and implantation. Further clinical evaluation with a larger group of patients is needed.

Safety and efficacy of flow re-direction endoluminal device (FRED) in the treatment of cerebral aneurysms: a single center experience

“…In the group of large aneurysms whose follow-up was available, only 6/8 (75 %) [20,25] were occluded at the last follow-up, while the occlusion rate of giant aneurysms was even lower (57 % or 4/7). Conversely, aneurysms located beyond the circle of Willis, as ACA [17,20], showed complete occlusion at the last followup, at 3, 6, and 12 months, respectively.…”

“…Four recent studies [12,17,20,25] have reported the experience of treatment of cerebral aneurysms by FRED FDD. The data of these series and our own, including 103 patients with 107 aneurysms, are summarized in Table 4.…”

“…The rate of complete occlusion, reported only in four studies [17,20,25] (including ours), was 45/78 (58 %) at 3 months, 44/59 (74 %) at 6 months, and 28/30 (93 %) at 12 months. No deaths occurred in the analyzed series.…”

“…Almost all studies report experiences with PED and Silk [1, 6-10, 14, 18, 19, 21-24, 26-28, 31]; on the other hand, the experience with new devices as FRED [12,17,20,25] or p64 [4,13] is still limited.…”

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

“…It is characterized by a 2-layer structure consisting of high-porosity outer and low-porosity inner layers. [10][11][12] To introduce this product in Japan, a clinical trial involving four institutions in Japan has been conducted since 2013. In Toranomon Hospital, the trial was started after its protocol was approved by the Ethics Review Board, and is currently being conducted.…”