Embozene Color-Advanced Microspheres

FDA-Cleared Indications

• Embolization of blood vessels when reducing or stopping blood flow is clinically indicated.
• Use as an embolic agent in vascular interventional procedures.

Clinical Applications

• Catheter-directed embolization of selected arteries or other blood vessels.
• Reduction of blood flow to a targeted vascular territory when clinically indicated.
• Treatment of vascular conditions in which intentional vessel occlusion is part of the planned procedure.

Reported off-label uses

• Uterine artery embolization for symptomatic uterine fibroids or adenomyosis.
• Prostatic artery embolization for benign prostatic enlargement.
• Genicular artery embolization for selected chronic knee pain conditions.
• Embolization of tumor-feeding vessels in selected oncology procedures.

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

• Particle size selection depends on the target vessel, vascular anatomy, desired level of occlusion, and the risk of unintended embolization.
• The microspheres must be compatible with the selected microcatheter and injected under fluoroscopic imaging by a trained operator.
• They are permanent embolic agents; once deployed, they are not intended to be retrieved or absorbed.
• MRI safety and conditional-use information should be confirmed in the current product labeling and institutional protocol before MRI.
• Potential contraindications and precautions include uncorrectable bleeding disorders, severe contrast-media reactions, infection in the access or treatment area, and blood flow patterns that create a risk of non-target embolization.