CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 23 Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 2.0 mm Humanitarian Device USA ONLY): Authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular, or fusiform aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4mm. Wide-neck is defined as having a neck width greater than or equal to 4mm or a dome-to-neck ratio less than 2mm. The effectiveness of this device for this use has not been demonstrated.
A sterile 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)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.
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