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The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm defines the neck width as ≥ 4 mm or a dome-to-neck ratio < 2.

The Comaneci Embolization Assist Device consists of three device models: Comaneci, Comaneci Petit, and Comaneci 17 (see Table 1). The Comaneci Embolization Assist Device is intended for temporary use and is introduced through an endovascular approach to the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width < 10 mm. The device consists of a nitinol fine wire mesh region at the distal end mounted on a flexible shaft that expands and contracts when the physician pulls a core wire that is coated with polytetrafluoroethylene (PTFE) and connected to a handle with a control slider made of a styrene-butadiene copolymer (Figures 1 and 2). The fine wire mesh region on the Comaneci Embolization Assist Device is unique in that it is not self-expandable but is directly controlled by the physician to size this region of the device to the parent vessel. The wires of the mesh are radiopaque, which allows the physician to visualize the mesh under fluoroscopy. The Comaneci and Comaneci Petit models are delivered through a microcatheter with an internal diameter (ID) of 0.021 inches and the Comaneci 17 is delivered through a microcatheter with an ID of 0.017 inches. The devices are packaged in a sterile pouch and are intended for single use only.