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Neuroform Atlas
Stent System
The Neuroform Atlas Stent System is purposefully designed to provide the coil support and wall apposition needed to perform effective stent-assisted coiling procedures. The Neuroform EZ Stent System is authorized under a Humanitarian Device Exemption (HDE). IRB approval is required prior to use.*
*Neuroform Atlas Stent System is authorized under a Humanitarian Device Exemption (HDE). IRB approval is required prior to use. Neuroform Atlas Stent System is authorized by Federal law for use with neurovascular embolic coils in patients who are ≥ 18 years of age for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ≥ 2 mm and ≤ 4.5 mm that are not amenable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck ≥ 4 mm or a dome-to-neck ratio < 2. The effectiveness of this device for this use has not been demonstrated.
AP002333v1.0