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Stryker receives US FDA HDE approval for the Neuroform Atlas Stent System to treat wide neck aneurysms

Press releases may be edited for formatting or style | November 09, 2017 Cardiology Stents

Humanitarian Device. 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.

Stryker completed enrollment of the anterior arm of the Neuroform Atlas US IDE clinical trial earlier this year while enrollment continues for the posterior arm. This important trial represents the largest data set on adjunctive stent use with intracranial aneurysm coiling and reflects Stryker's commitment to clinical leadership within the neurovascular space.

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About Stryker

Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

SOURCE Stryker

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