Stryker landed FDA approval for its Neuroform Atlas stent via a humanitarian device exemption (HDE). The nitinol stent is intended for use along with neurovascular embolic coils to treat wide neck, intracranial, saccular aneurysms. The coils are used to pack aneurysms, while the Neuroform Atlas stent is placed across the neck of the aneurysms to provide structural support for the vessel.
The device features a hybrid cell design and the lowest profile delivery system currently available in the United States, helping to reach difficult locations within the brain. This will allow more patients to be applicable to receiving stenting therapy that would otherwise be ineligible due to safety concerns.
The device is now available in 46 countries around the world and the latest FDA approval was based on the U.S. Neuroform Atlas investigational trial. Dr. Osama O. Zaidat, Director of the Neuroscience and Stroke Center at Mercy Hospital in Toledo, Ohio, and Co-Principal Investigator of the trial, in a statement said, “The hybrid cell stent design of Neuroform Atlas is designed to improve wall apposition, ease of use, deployment accuracy, and catheter re-entry in even the most challenging cases. The Atlas design may improve patient care by facilitating the treatment of wide neck aneurysms in tortuous and more complex anatomies.”