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FDA OKs Stryker's self-expanding nitinol stent

The FDA has granted Stryker premarket approval for its Neuroform Atlas stent system, a self-expanding stent designed for use with embolic detachable coils to treat patients with wide-neck, intracranial aneurysms. The nitinol stent, which previously received humanitarian device exemption approval, can now be used in conjunction with neurovascular embolization coils to treat patients ages 18 years or older who have saccular wide-necked intracranial aneurysms that arise from a 2 mm to 4.5 mm-diameter parent vessel.

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