A device under a post-market surveillance study is FDA approved to be marketed and sold while collecting, analyzing, and interpreting data about a marketed device which may find new information regarding its safety and effectiveness. An Imaging Nurse or Technologist will discuss participating with you, if you are interested. Once screened for eligibility, you will be provided any preparation instructions required for the study.
- 12671 Use of Codman Enterprise Vascular Reconstruction Device (VRD) and Delivery System (DS) in Brain Aneurysms--A Humanitarian Use Device (HUD)
Disease: Brain Aneurysm
Summary: This device allows the safe placement of metal coils into a brain aneurysm to help close it. A stent--a tubular metallic mesh--is then permanently placed inside the blood vessel to hold the coils in the aneurysm and keep the blood vessel open.
- 10705: Wingspan Stent System With Gateway PTA Balloon Catheter: A Humanitarian Use Device
Disease: Blockage of Arteries in the Brain
Summary: The purpose of this is to offer the use of the Wingspan® Stent and Gateway Balloon Cather device for treatment of patients with neurovascular disease, including recurrent stroke due to blockage of brain vessels which doesn't respond to medical therapy.
- 4085 Use of the Neuroform Stent System® for Treatment of Wide Neck, Intracranial, Saccular Aneurysms--A Humanitarian Use Device
Disease: Wide Neck Intracranial Saccular Aneurysms
Summary: The Neuroform 3 Microdelivery Stent System and NeuroformEZ® Stent System are intended to treat patients who have a wide neck intracranial (inside the brain) saccular aneurysm which cannot be treated surgically.