Medical technology company Stryker reported on Monday the receipt of the US Food and Drug Administration (FDA) Premarket Approval (PMA) for the Neuroform Atlas Stent System for brain aneurysm treatment.

According to the company, the Neuroform Atlas Stent System is a self-expanding nitinol stent used in conjunction with metal coils to pack weakened blood vessel sacs called aneurysms within the brain. The stent is positioned across the aneurysm neck to hold metal coils and occlude the aneurysm.

The Neuroform Atlas Stent System is indicated for use with neurovascular embolization coils in the anterior circulation of the neurovasculature for the endovascular treatment of patients ≥ 18 years of age with saccular wide-necked intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.0 mm and ≤ 4.5 mm. It is only the second aneurysm adjunctive stent to be granted PMA approval for the treatment of wide-neck, intracranial aneurysms in conjunction with embolic detachable coils.

Stryker added that the US FDA PMA approval was granted based on robust clinical trial evidence proving the efficacy of the device.

Previously, the Neuroform Atlas Stent System was approved under a humanitarian device exemption restricting use to specific hospitals with institutional review board approval, concluded the company.