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Multicenter Study
. 2021;50(4):464-471.
doi: 10.1159/000514371. Epub 2021 May 10.

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

M Asif Taqi  1 , Eytan Raz  2 , Anastasia Vechera  1 , Maksim Shapiro  2 , Rishi Gupta  3 , Joseph Haynes  4 , Philipp Taussky  5 , Ramesh Grandhi  5 , Howard A Riina  6 , Peter Kim Nelson  2 , Erez Nossek  6
Affiliations
Multicenter Study

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

M Asif Taqi et al. Cerebrovasc Dis. 2021.

Abstract

Background: 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.

Method: 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.

Results: 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.

Conclusions: Our initial experience shows that the Comaneci device is a promising and reliable tool that can safely support coil remodeling of WNAs.

Keywords: Aneurysm; Bridging device; Coil embolization; Comaneci.

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Conflict of interest statement

Erez Nossek is a consultant for Rapid Medical. Rishi Gupta is the primary investigator of the TIGER Study. Muhammad Asif Taqi is a consultant for Rapid Medical and a site investigator of the TIGER Study. Philipp Taussky is a consultant for Medtronic, Stryker, and Cerenovus. Howard A. Riina is a consultant for Medtronic.

Figures

Fig. 1
Fig. 1
Unruptured MCA aneurysm. Wide neck involving mainly the inferior division. a, b 3D reconstruction of the right ICA. c Lateral oblique 2D DSA demonstrating the MCA aneurysm with a daughter sac pointing superiorly. d, e Unsubtracted angiograms showing inflated Comaneci while the first framing coil is pushed and after the last coil is deployed into the aneurysm. f DSA final result demonstrating complete occlusion of the aneurysm. MCA, middle cerebral artery; ICA, internal carotid artery.
Fig. 2
Fig. 2
Previously coiled, ruptured wide-neck, dysplastic PCOM aneurysm. a, b 3D reconstruction of the right ICA. c Anteroposterior oblique 2D DSA demonstrating the PCOM aneurysm with a daughter sac pointing superiorly and the compacted coil mass. A large PCOM is noted. d, e Unsubtracted image showing the inflated Comaneci after the first framing coil is deployed and after the last coil is deployed into the aneurysm. f DSA final result demonstrating near-complete occlusion of the aneurysm and patent PCOM artery. PCOM, posterior communicating artery; ICA, internal carotid artery.
Fig. 3
Fig. 3
Photographs of the Comaneci device. a The “deflated” Comaneci device after unsheathing the device from the microcatheter. b The Comaneci after “inflation” in a tube. c The handle of the Comaneci with its yellow adjustable slider on top, allowing for incremental control.
See this image and copyright information in PMC

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