Onyx Liquid Embolic System

FDA-Cleared Indications

• The FDA record for PMA P030004 describes a manufacturing change: removing mycoplasma testing from the incoming-inspection acceptance criteria for non-sterile DMSO.
• This record does not provide a complete clinical indication statement for the Onyx device itself.

Clinical Applications

• Use in labeled endovascular embolization procedures when the specific Onyx product labeling supports treatment of a target vascular lesion.
• Catheter-based occlusion of selected neurovascular blood vessels under fluoroscopic imaging.
• Embolization of vascular lesions such as arteriovenous malformations or dural arteriovenous fistulas when included in the applicable product labeling.

Reported off-label uses

• Embolization of selected extracranial or peripheral vascular lesions has been reported in clinical practice, but use depends on the specific product labeling, anatomy, and institutional protocols.
• Embolization of selected tumors or tumor-feeding vessels has been described in the literature for liquid embolic agents, but this should not be interpreted as an FDA-approved indication for every Onyx product.

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 system is delivered through a compatible microcatheter and requires dimethyl sulfoxide-compatible equipment; the treating team must follow the device instructions for preparation, injection, and catheter removal.
• Onyx is injected under fluoroscopic guidance, and controlled delivery may require intermittent injection and waiting periods to allow the material to solidify.
• The device is intended for use by trained specialists familiar with neurovascular embolization and management of complications such as non-target embolization, ischemia, hemorrhage, or catheter entrapment.
• MRI safety depends on the complete implanted system, including the embolic material, delivery catheter, and any associated devices; the current product labeling should be reviewed before MRI.
• Contraindications and precautions include allergy or intolerance to device components, inability to safely catheterize the target vessel, significant risk of reflux or non-target embolization, and failure to maintain appropriate imaging and hemodynamic monitoring.