Embozene Color-Advanced Microspheres Embozene Opaque Non-Colored Microspheres Oncozene Microspheres

FDA-Cleared Indications

• Embolization of hypervascular tumors.
• Embolization of arteriovenous malformations.

Clinical Applications

• Catheter-directed embolization of selected hypervascular tumors.
• Embolization of selected arteriovenous malformations.
• Reduction or interruption of blood flow to a targeted vascular bed when consistent with the device labeling.

Reported off-label uses

• Uterine artery embolization for symptomatic uterine fibroids.
• Transarterial chemoembolization for liver tumors.
• Embolization of selected bleeding vessels.
• Preoperative devascularization of selected 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

• Microspheres are available in different size ranges; selection depends on the target-vessel diameter, vascular anatomy and desired level of embolization.
• The particles are delivered through a compatible catheter or microcatheter under fluoroscopic or other appropriate imaging guidance.
• The operator must avoid non-target embolization, reflux and injection into vessels supplying critical organs or normal tissue.
• MRI safety and artifact information should be verified in the current manufacturer’s labeling; the embolic material is intended to remain in the treated vessel.
• Contraindications, warnings, preparation, suspension and injection instructions should be reviewed in the current FDA-cleared labeling before use.