Embozene Microspheres

FDA-Cleared Indications

• Embolization of blood vessels when vascular occlusion is clinically indicated.
• Use as an embolic material delivered through a catheter to promote occlusion of selected vessels.
• Use in interventional procedures requiring controlled reduction or cessation of blood flow.

Clinical Applications

• Catheter-directed embolization of selected arteries for vascular occlusion.
• Embolization procedures performed for treatment of hypervascular lesions when consistent with the device labeling and clinical indication.
• Adjunctive vascular embolization during image-guided interventional radiology procedures.

Reported off-label uses

• Prostatic artery embolization for symptomatic benign prostatic hyperplasia.
• Genicular artery embolization for chronic knee osteoarthritis pain.
• Embolization of selected tumor-feeding arteries, including procedures such as transcatheter arterial chemoembolization.
• Embolization of selected vascular malformations.

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

• Microsphere size selection depends on the target vessel, vascular anatomy, desired level of occlusion and risk of non-target embolization.
• The particles are delivered through a compatible catheter using image guidance; careful suspension and administration technique are required to reduce aggregation and catheter blockage.
• Use requires angiography to identify the target vessels and assess collateral flow before and after embolization.
• MRI safety and artifact information should be confirmed in the current manufacturer labeling and device-specific instructions for use; the particles are administered through a delivery catheter rather than implanted as a metallic device.
• Contraindications and precautions include inability to safely catheterize the target vessel, significant risk of non-target embolization, uncorrectable coagulopathy, active infection at the access site or allergy to relevant contrast or delivery materials.