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

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

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.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Device Approval
  • Embolization, Therapeutic / adverse effects
  • Embolization, Therapeutic / instrumentation*
  • Equipment Design
  • Female
  • Humans
  • Intracranial Aneurysm / diagnostic imaging
  • Intracranial Aneurysm / therapy*
  • Male
  • Middle Aged
  • Retrospective Studies
  • Treatment Outcome
  • United States
  • United States Food and Drug Administration