COMETIU^® Intracranial Self-expanding Drug Stent System

COMETIU® has obtained CE approval.
The COMETIU® Intracranial Self-Expanding Drug Coated Stent System with COMEX Balloon Microcatheter have received FDA Breakthrough Device Designation under the Breakthrough Devices Program. This designation allows prioritized review of devices for life-threatening or irreversibly debilitating conditions; it is not a marketing authorization. COMETIU® is not currently approved for sale in the United States and is not approved for clinical use in the United States.