Definition: An Intracranial Coil-assist Stent Is A Tubular Device Placed In An Artery In The Brain To Assist In The Placement And Retention Of Embolic Coils For The Treatment Of Wide-neck Intracranial Aneurysms.
| Device Type ID | 3868 |
| Device Name | Intracranial Coil-assist Stent |
| Physical State | The Device Is A Tubular Mesh Permanent Implant That Is Attached To A Delivery Wire. |
| Technical Method | The Device Provides Mechanical Support For Embolic Coils That Are Placed Into The Aneurysm For Treatment. The Device Prevents Coils From Prolapsing Into The Vessel Lumen. The Device Is Implanted Using Minimally Invasive Endovascular Techniques. |
| Target Area | Neurovasculature |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | QCA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3868 |
| Device | Intracranial Coil-assist Stent |
| Product Code | QCA |
| FDA Device Classification | Class 3 Medical Device |