www.fdanews.com/articles/184374-stryker-receives-humanitarian-device-exemption-for-neuroform-atlas-stent
Stryker Receives Humanitarian Device Exemption for Neuroform Atlas Stent
November 13, 2017
Stryker Corporation received FDA approval for the Neuroform Atlas Stent System for marketing under a humanitarian device exemption.
The device is a small nitinol stent that is used in conjunction with metal coils to pack weakened blood vessel sacs in the brain.
The system can be used with neurovascular embolic coils for the treatment of wide neck, intracranial, and saccular aneurysms.