Onyx

FDA-Cleared Indications

• The supplied FDA indication text is listed only as "Statement," so a specific FDA-cleared indication cannot be reliably reproduced from the available record.
• The product code GKZ is associated with liquid embolic agents used to occlude or reduce blood flow in selected abnormal vascular structures.

Clinical Applications

• Catheter-directed embolization of selected abnormal vascular structures when consistent with the device labeling.
• Embolization procedures in which a liquid embolic agent is used to reduce or stop blood flow through a target vessel.

Reported off-label uses

• Embolization of brain arteriovenous malformations.
• Embolization of dural arteriovenous fistulas.
• Preoperative or palliative embolization of selected spinal or other hypervascular tumors.

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

• Onyx is delivered through a compatible microcatheter using dimethyl sulfoxide; catheter and syringe compatibility must be confirmed before use.
• It is injected under fluoroscopic or angiographic guidance, and the operator must control the injection rate and volume to limit unintended reflux or embolization.
• The agent solidifies in the target vessel, but the treated anatomy and the final embolic cast should be assessed with follow-up imaging when clinically appropriate.
• Contraindications and warnings include allergy or intolerance to device components, unsuitable vascular anatomy, uncontrolled contrast or procedural risks, and situations in which non-target embolization cannot be adequately prevented.
• MRI safety depends on the complete implanted device system and the manufacturer’s current labeling; the patient’s treatment record should be reviewed before MRI.