Enterprise 2 Vascular Reconstruction Device

Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization With the Codman Enterprise 2 Vascular Reconstruction Device.

The primary objective of this study is to collect data regarding the effectiveness of using the Enterprise 2 Reconstruction Device in successfully embolizing intracranial aneurysms with wide neck configuration.

The Codman Enterprise 2 Vascular Reconstruction Device is a self-expanding nitinol, compliant, closed-cell, recapturable design that can be deployed by a single operator. The Codman Enterprise 2 Vascular Reconstruction Device is packaged sterile as a single unit with an introducer sheath and a detachable push wire.

This device was designed to assist in the stent-assisted coil embolization of intracranial aneurysms, specifically those that have a wide neck that would not otherwise maintain the coil embolization material within the aneurysm because of the wide opening at the base of the aneurysm. The Codman Enterprise 2 Vascular Reconstruction Device is approved by the FDA as a Humanitarian Use Device (HUD) in cases of wide-necked saccular cerebral aneurysms.

The primary objective of this study is to collect data regarding the effectiveness of using the Enterprise 2 Reconstruction Device in successfully embolizing intracranial aneurysms with wide neck configuration. Secondly, to determine any safety or delivery problems that may occur, or any adverse patient events that may have previously been undocumented.

Inclusion Criteria:

• Adult patients (18 years old or older) with intracranial aneurysms with a wide neck (defined as > or = to 4mm, or with a dome to neck ratio of 2:1 or greater).

Exclusion Criteria:

• Small-necked aneurysms, inappropriate for stenting.
• Inability to tolerate anti-platelet medication.