Codman Enterprise Vascular Reconstruction Device & Delivery System

Title: “Humanitarian Use Device for wide neck intracranial (brain) saccular/fusiform (like a balloon) aneurysms either ruptured or unruptured.”

Study Sponsor: Johnson & Johnson, Inc.

Principal Investigator: Matthew Lawson, MD

Study Synopsis: The use of the Codman Enterprise Stent under the approval of the Humanitarian Device Exemption (HDE) H060001in treatment of wide neck aneurysms via an endovascular approach.

The CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System is a new device that has been approved by the Food and Drug Administration (FDA) as a Humanitarian Use Device (HUD) for use as an alternative treatment. A HUD device used to diagnose or treat a disease or condition affecting fewer than 4,000 individuals in the United States per year. The probable benefit to health outweighs the risks of injury or illness.

Study Status: Only for patients with wide neck intracranial aneurysm(s), either ruptured or unruptured.

For more information, contact Lutheria Hollis, CCRC, at (850) 877-5115.

Call Us (850) 877-5115