Coils
Optima Coil System (OptiOne Coil System)
by Balt USA LLC
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.
Optima Coil System (OptiOne Coil System) 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 |
|---|---|---|---|
| OPTIONE3L | — | MR Conditional | Available |
| OPTIONE3M | — | MR Conditional | Available |
| OPTIONE3S | — | MR Conditional | Available |
| OPTIONE4L | — | MR Conditional | Available |
| OPTIONE4L | — | MR Conditional | Available |
| OPTIONE4M | — | MR Conditional | Available |
| OPTIONE4M | — | MR Conditional | Available |
| OPTIONE4S | — | MR Conditional | Available |
| OPTIONE4S | — | MR Conditional | Available |
| OPTIONE5L | — | MR Conditional | Available |
| OPTIONE5L | — | MR Conditional | Available |
| OPTIONE5M | — | MR Conditional | Available |
| OPTIONE5M | — | MR Conditional | Available |
| OPTIONE5S | — | MR Conditional | Available |
| OPTIONE5S | — | MR Conditional | Available |
| OPTIONE5XL | — | MR Conditional | Available |
| OPTIONE5XL | — | MR Conditional | Available |
| OPTIONE6L | — | MR Conditional | Available |
| OPTIONE6L | — | MR Conditional | Available |
| OPTIONE6M | — | MR Conditional | Available |
| OPTIONE6M | — | MR Conditional | Available |
| OPTIONE6S | — | MR Conditional | Available |
| OPTIONE6S | — | MR Conditional | Available |
| OPTIONE6XL | — | MR Conditional | Available |
| OPTIONE6XL | — | MR Conditional | Available |
| OPTIONE35L | — | MR Conditional | Available |
| OPTIONE35M | — | MR Conditional | Available |
| OPTIONE35S | — | MR Conditional | Available |
| OPTIONE45L | — | MR Conditional | Available |
| OPTIONE45L | — | MR Conditional | Available |
| OPTIONE45M | — | MR Conditional | Available |
| OPTIONE45M | — | MR Conditional | Available |
| OPTIONE45S | — | MR Conditional | Available |
| OPTIONE45S | — | MR Conditional | Available |
| OPTIONE55L | — | MR Conditional | Available |
| OPTIONE55L | — | MR Conditional | Available |
| OPTIONE55M | — | MR Conditional | Available |
| OPTIONE55M | — | MR Conditional | Available |
| OPTIONE55S | — | MR Conditional | Available |
| OPTIONE55S | — | MR Conditional | Available |
| OPTIONE55XL | — | MR Conditional | Available |
| OPTIONE55XL | — | MR Conditional | Available |
FDA clearances
- 510(k) K254221 January 2026
- 510(k) K252700 September 2025
Procedures that use coils
Frequently asked questions
What is Optima Coil System (OptiOne Coil System) 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 Optima Coil System (OptiOne Coil System)?
Optima Coil System (OptiOne Coil System) is made by Balt USA LLC. It is listed under embolization coils in our device library.
What sizes does Optima Coil System (OptiOne Coil System) come in?
The FDA device database does not list sizes for Optima Coil System (OptiOne Coil System). Check the instructions for use or ask a Balt USA LLC representative.
Is Optima Coil System (OptiOne Coil System) MRI safe?
The FDA device database lists Optima Coil System (OptiOne Coil System) as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Optima Coil System (OptiOne Coil System) FDA cleared?
Optima Coil System (OptiOne Coil System) is covered by FDA submissions K252700, K254221.
How do I contact a Balt USA LLC sales representative?
Balt USA LLC has not listed representatives on LA Vascular yet. Visit the Balt USA LLC 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.