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Comaneci
The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms under fluoroscopic guidance. The Comaneci is comprised of a collapsible, fully retrievable, fine wire construction mounted on a wire shaft that expands to comply with the vessel diameter. It is delivered through a neurovascular microcatheter. The Comaneci is provided with a 3.5 French (F) peelable loading sheath.
Details
Device typeBare-metal intracranial vascular stent: A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)]; it does not include a polymer tube (i.e., not a stent-graft). Disposable devices associated with implantation (e.g., balloon catheter) may be packaged with the stent.
FDA categoryTemporary Coil Embolization Assist Device
Device ID07290015107136
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information