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.
- 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.