The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization ofvascular abnormalities described in the intended use.The Numen Coil Embolization System is composed of two parts as described below:*An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter.*The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. Thepusher is used to deliver the coil implant to the target lesion.
A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.