Humanitarian Use Device: CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System

Service: Trial Number:
052-12
Principal Investigator:
Gary R. Duckwiler
Conducted at:
Long Beach Memorial
Currently enrolling additional patients:
Yes
Age Range:
18 years & up

An intracranial aneurysm is a protruding sac off of an artery in the brain that can grow over time and eventually rupture causing bleeding inside the brain. The procedure consists of placement of the Self-Expanding Stent System through a microcatheter (very small and flexible tube) to the intended location. The stent expands and takes the shape of the blood vessel. The aneurysm is then entered with a small catheter to deliver coils into the aneurysm sac. The stent helps keep the coils inside the aneurysm sac. The FDA has designated the CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System as a Humanitarian Use Device (HUD). The HDE availability of stents for this purpose will expand our ability to treat wide neck aneurysms. The Enterprise Microdelivery Stent is indicated for use with detachable (rem coils for the treatment of wide necked intracranial saccular aneurysms arising from a parent vessel with a diameter greater than 2mm and less than 4.5mm that are not amenable to treatment with surgical clipping. 

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