Early Experience with Comaneci, a Newly FDA-Approved Controllable Assist Device for Wide-Necked Intracranial Aneurysm Coiling

Abstract

<b><i>Background:</i></b> Comaneci (Rapid Medical) is a compliant, adjustable mesh that provides temporary scaffolding during coiling of wide-necked intracranial aneurysms (WNAs) that preserves antegrade flow. We report our early multi-institutional experience with the Comaneci device in the USA. <b><i>Method:</i></b> We reviewed all patients with WNAs that were treated using the Comaneci device for coil remodeling of ruptured and unruptured aneurysms at 4 institutions between July 2019 and May 2020. Clinical characteristics, angiographic variables, and endovascular results were assessed. <b><i>Results:</i></b> A total of 26 patients were included (18 women). The mean age was 62.7 years (range 44–81). Fifteen patients presented with ruptured aneurysms and 11 with unruptured aneurysms. The mean aneurysm neck width was 3.91 mm (range 1.9–6.5) with a mean dome-to-neck ratio of 1.57 (range 0.59–3.39). The mean maximum width was 5.80 mm (range 3.0–9.9) and the mean maximum height was 5.61 mm (range 2.0–11.8). Successful aneurysm occlusion was achieved in 25 of 26 patients. Complete occlusion was achieved in 16 patients, near-complete occlusion was observed in 9 patients, and 1 patient demonstrated residual filling. The mean time of device exposure was 24 min (range 8–76). No vasospasm was observed at the device location. Clot formation on the device was noted in 2 separate cases, but there were no clinical sequelae. There was 1 intraprocedural complication in a case that involved the simultaneous use of 2 Comaneci devices. <b><i>Conclusions:</i></b> Our initial experience shows that the Comaneci device is a promising and reliable tool that can safely support coil remodeling of WNAs.

COManeci MechANical Dilation for vasospasm (COMMAND): multicenter experience

“…However, it provides a controlled user-dependent, sequentially higher degree of radial force, at each incremental increase of the device diameter when compared with the Solitaire stents (figure 2). 11 It is currently FDA-approved as a temporary bridging device for assisted coiling of wide-necked aneurysms, which has been reported in multiple early experience series, with good efficacy and safety profiles 9 26–28. In the present experience with the Comaneci device for mechanical dilation for vasospasm treatment we found it to be successfully navigable into segments distal to the circle of Willis (24.8% of the treated vessels), which can be challenging to access with conventional balloons 16 19 23.…”

“…Other single-center reports have described the utility of other commercially available stent retrievers for mechanical endovascular dilation of symptomatic vasospasm with encouraging results 6–8. Comaneci (Rapid Medical, Yokneam, Israel) is a compliant, adjustable braided mesh that is currently Food and Drug Administration (FDA)-approved as a temporary bridging device for assisted coiling of wide-necked intracranial aneurysms 9. Its current utility for mechanical endovascular dilatation for refractory intracranial vasospasm is an off-label indication, with only a few reported preliminary experiences 10–12.…”

A systematic review and meta-analysis of Comaneci/Cascade temporary neck bridging devices for the treatment of intracranial aneurysms

“…Among the 11 records that obtained the full text, one was excluded due to data overlap, and one was excluded due to limited information (only an abstract). Therefore, in the final quantitative analysis, we included a total of nine records ( Sirakov et al, 2018 ; Fischer et al, 2020 ; Molina-Nuevo et al, 2020 ; Sirakov S. et al, 2020 ; Sirakov A. et al, 2020 ; Tomasello et al, 2020 ; Lim et al, 2021 ; Taqi et al, 2021 ; Vinacci et al, 2022 ). Please refer to Figure 1 for the specific screening process.…”

“…, Unlike intrasaccular flow disruption devices, Comaneci and Cascade are metal stents that can be temporarily used for the embolization of IAs, similar in principle to balloon-assisted embolization of IAs ( Sirakov et al, 2022 ). The difference is that the stent structure can ensure the assistance of embolization without affecting blood flow, and compared to the filling state after balloon dilation, the inherent soft structure of Comaneci/Cascade can also reduce the risk of vascular rupture ( Taqi et al, 2021 ). Moreover, Comaneci/Cascade have low requirements for antiplatelet therapy, so they have great potential for safe use in ruptured IAs.…”

“…Moreover, Comaneci/Cascade have low requirements for antiplatelet therapy, so they have great potential for safe use in ruptured IAs. A recent study compared the efficacy of Comaneci, stents, and balloons in the treatment of IAs in the acute phase ( Taqi et al, 2021 ). Among them, Comaneci has a lower incidence of hemorrhagic and thromboembolic complications while maintaining a similar occlusive effect to stents and balloons.…”