Neuroform Microdelivery Stent System

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

Study Sponsor: Boston Scientific

Principal Investigator: Matthew Lawson, MD

Study Synopsis: The Neuroform Microdelivery Stent System is authorized by the Federal Law for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ≥ 2mm and ≤4.5mm that are not amenable to treatment with surgical clipping.

The Neuroform™ Microdelivery Stent System or Neuroform EZ is a 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 is a 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