Optima Coil System (OptiOne Coil System)

FDA-Cleared Indications

• For use in the embolization of intracranial aneurysms.
• For use in the embolization of other neurovascular lesions or vessels when the device is used according to its FDA-cleared labeling.
• The device is a Class II neurovascular embolization device under product code HCG and 21 CFR 882.5950.

Clinical Applications

• Catheter-based coiling of selected brain aneurysms.
• Embolization of selected intracranial vascular lesions.
• Occlusion of targeted neurovascular vessels when coil embolization is clinically appropriate.
• Use during neurointerventional procedures performed through an angiographic catheter.

Reported off-label uses

• Coil embolization of selected extracranial or peripheral vessels may be performed with coil systems as a device-category practice, but this should not be assumed to be included in the Optima Coil System's FDA-cleared indication.
• Use in selected non-neurovascular embolization procedures may occur in clinical practice, but requires physician judgment and confirmation of device labeling, compatibility, and applicable regulatory requirements.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The coil diameter, length, and configuration must be matched to the target vessel or aneurysm and the delivery catheter specified in the manufacturer's instructions for use.
• Deployment is performed through a catheter under fluoroscopic or angiographic guidance, generally with local anesthesia and moderate sedation or general anesthesia depending on the procedure.
• The system is intended for use by trained physicians familiar with neurovascular embolization, including assessment of vessel anatomy, catheter stability, and the risk of unintended embolization.
• MRI safety and conditions should be confirmed in the current manufacturer labeling before scanning; do not assume that every coil configuration has identical MRI conditions.
• Potential contraindications and precautions include unsuitable vascular anatomy, inability to safely position the delivery catheter, active infection at the treatment site, allergy or intolerance to relevant materials or contrast media, and conditions in which embolization would create unacceptable ischemia.