Coils
Axium PrimeTM
A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
Axium PrimeTM models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| APB-1-1-HX-ES | — | MR Conditional | Available |
| APB-1-2-3D-ES | — | MR Conditional | Available |
| APB-1-2-HX-ES | — | MR Conditional | Available |
| APB-1-3-3D-ES | — | MR Conditional | Available |
| APB-1-3-HX-ES | — | MR Conditional | Available |
| APB-1-4-3D-ES | — | MR Conditional | Available |
| APB-1.5-1-HX-ES | — | MR Conditional | Available |
| APB-1.5-2-3D-ES | — | MR Conditional | Available |
| APB-1.5-2-HX-ES | — | MR Conditional | Available |
| APB-1.5-3-3D-ES | — | MR Conditional | Available |
| APB-1.5-3-HX-ES | — | MR Conditional | Available |
| APB-1.5-4-3D-ES | — | MR Conditional | Available |
| APB-1.5-4-HX-ES | — | MR Conditional | Available |
| APB-2-1-HX-ES | — | MR Conditional | Available |
| APB-2-2-3D-ES | — | MR Conditional | Available |
| APB-2-2-HX-ES | — | MR Conditional | Available |
| APB-2-3-3D-ES | — | MR Conditional | Available |
| APB-2-3-HX-ES | — | MR Conditional | Available |
| APB-2-4-3D-ES | — | MR Conditional | Available |
| APB-2-4-HX-ES | — | MR Conditional | Available |
| APB-2-6-HX-ES | — | MR Conditional | Available |
| APB-2-8-HX-ES | — | MR Conditional | Available |
| APB-2.5-3-HX-ES | — | MR Conditional | Available |
| APB-2.5-4-3D-ES | — | MR Conditional | Available |
| APB-2.5-4-HX-ES | — | MR Conditional | Available |
| APB-2.5-6-3D-ES | — | MR Conditional | Available |
| APB-2.5-6-HX-ES | — | MR Conditional | Available |
| APB-2.5-8-HX-ES | — | MR Conditional | Available |
| APB-3-4-3D-ES | — | MR Conditional | Available |
| APB-3-4-HX-ES | — | MR Conditional | Available |
| APB-3-6-3D-ES | — | MR Conditional | Available |
| APB-3-6-HX-ES | — | MR Conditional | Available |
| APB-3-8-3D-ES | — | MR Conditional | Available |
| APB-3-8-HX-ES | — | MR Conditional | Available |
| APB-3-10-HX-ES | — | MR Conditional | Available |
| APB-3.5-6-3D-ES | — | MR Conditional | Available |
| APB-3.5-8-3D-ES | — | MR Conditional | Available |
| APB-3.5-10-3D-ES | — | MR Conditional | Available |
| APB-4-6-3D-SS | — | MR Conditional | Available |
| APB-4-6-HX-SS | — | MR Conditional | Available |
| APB-4-8-3D-SS | — | MR Conditional | Available |
| APB-4-8-HX-SS | — | MR Conditional | Available |
| APB-4-10-3D-SS | — | MR Conditional | Available |
| APB-4-10-HX-SS | — | MR Conditional | Available |
| APB-4-12-3D-SS | — | MR Conditional | Available |
| APB-4-12-HX-SS | — | MR Conditional | Available |
| APB-5-8-3D-SS | — | MR Conditional | Available |
| APB-5-10-3D-SS | — | MR Conditional | Available |
| APB-5-10-HX-SS | — | MR Conditional | Available |
| APB-5-15-3D-SS | — | MR Conditional | Available |
| APB-5-15-HX-SS | — | MR Conditional | Available |
| APB-5-20-HX-SS | — | MR Conditional | Available |
| APB-6-10-3D-SS | — | MR Conditional | Available |
| APB-6-12-HX-SS | — | MR Conditional | Available |
| APB-6-15-3D-SS | — | MR Conditional | Available |
| APB-6-20-3D-SS | — | MR Conditional | Available |
| APB-6-20-HX-SS | — | MR Conditional | Available |
| FC-3-6-3D | — | MR Conditional | Available |
| FC-3-8-3D | — | MR Conditional | Available |
| FC-3-10-3D | — | MR Conditional | Available |
| FC-3.5-6-3D | — | MR Conditional | Available |
| FC-3.5-8-3D | — | MR Conditional | Available |
| FC-3.5-10-3D | — | MR Conditional | Available |
| FC-4-6-3D | — | MR Conditional | Available |
| FC-4-8-3D | — | MR Conditional | Available |
| FC-4-10-3D | — | MR Conditional | Available |
| FC-4-12-3D | — | MR Conditional | Available |
| FC-4-15-3D | — | MR Conditional | Available |
| FC-5-8-3D | — | MR Conditional | Available |
| FC-5-10-3D | — | MR Conditional | Available |
| FC-5-15-3D | — | MR Conditional | Available |
| FC-5-20-3D | — | MR Conditional | Available |
| FC-6-10-3D | — | MR Conditional | Available |
| FC-6-15-3D | — | MR Conditional | Available |
| FC-6-20-3D | — | MR Conditional | Available |
| FC-6-25-3D | — | MR Conditional | Available |
| FC-7-12-3D | — | MR Conditional | Available |
| FC-7-15-3D | — | MR Conditional | Available |
| FC-7-20-3D | — | MR Conditional | Available |
| FC-7-30-3D | — | MR Conditional | Available |
| FC-8-15-3D | — | MR Conditional | Available |
| FC-8-20-3D | — | MR Conditional | Available |
| FC-8-30-3D | — | MR Conditional | Available |
| FC-9-20-3D | — | MR Conditional | Available |
| FC-9-30-3D | — | MR Conditional | Available |
| FC-10-20-3D | — | MR Conditional | Available |
| FC-10-30-3D | — | MR Conditional | Available |
| FC-10-40-3D | — | MR Conditional | Available |
| FC-12-30-3D | — | MR Conditional | Available |
| FC-12-40-3D | — | MR Conditional | Available |
| FC-12-50-3D | — | MR Conditional | Available |
| FC-14-30-3D | — | MR Conditional | Available |
| FC-14-40-3D | — | MR Conditional | Available |
| FC-14-50-3D | — | MR Conditional | Available |
| FC-16-40-3D | — | MR Conditional | Available |
| FC-16-50-3D | — | MR Conditional | Available |
| FC-18-40-3D | — | MR Conditional | Available |
| FC-18-50-3D | — | MR Conditional | Available |
| FC-20-50-3D | — | MR Conditional | Available |
| FC-22-50-3D | — | MR Conditional | Available |
| FC-25-50-3D | — | MR Conditional | Available |
FDA clearances
- 510(k) K162704 January 2017
- 510(k) K151447 July 2015
- 510(k) K081465 August 2008
Procedures that use coils
Frequently asked questions
What is Axium PrimeTM used for?
A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
Who makes Axium PrimeTM?
Axium PrimeTM is made by Micro Therapeutics, Inc.. It is listed under embolization coils in our device library.
What sizes does Axium PrimeTM come in?
The FDA device database does not list sizes for Axium PrimeTM. Check the instructions for use or ask a Micro Therapeutics, Inc. representative.
Is Axium PrimeTM MRI safe?
The FDA device database lists Axium PrimeTM as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Axium PrimeTM FDA cleared?
Axium PrimeTM is covered by FDA submissions K081465, K151447, K162704.
How do I contact a Micro Therapeutics, Inc. sales representative?
Micro Therapeutics, Inc. has not listed representatives on LA Vascular yet. Visit the Micro Therapeutics, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.