The Prestige Packing Coil consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Prestige Packing Coil delivery pusher is 185cm in length. It is designed for use with the Ultra Detachment Controller. The Ultra Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device which should not to be reused, re-sterilized, opened or tampered with. The Prestige Packing Coil and Ultra Detachment Controller(s) are sold separately. The Prestige Packing Coil achieves detachment by an internal heater element, which is powered by the Ultra Detachment Controller.
A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
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