FDA Humanitarian Device Exemption Approved for Stryker's Neuroform Atlas to Treat Wide-Neck Intracranial Aneurysms
November 9, 2017—Stryker Corporation announced that the US Food and Drug Administration has approved the company's Neuroform Atlas stent system for marketing under a humanitarian device exemption, allowing the immediate commencement of commercialization efforts in the United States.
According Stryker, the nitinol stent device 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. The effectiveness of this device for this use has not been demonstrated, advised the company.
Stryker completed enrollment of the anterior arm of the United States Neuroform Atlas investigational device exemption 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.
In the company's press release, Osama O. Zaidat, MD, commented, "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." Dr. Zaidat serves as Coprincipal Investigator of the United States Neuroform Atlas investigational trial.
Coprincipal Investigator Brian Jankowitz, MD, added, "The ability to navigate distal anatomy within the brain using the lowest profile delivery on the US market is a significant advantage to physicians. Atlas opens up treatment options for a new segment of patients that would otherwise have been considered too risky to treat."