Embozene Microspheres

FDA-Cleared Indications

• Embolization of blood vessels using catheter-based delivery.
• Use as an embolic material to promote vascular occlusion in selected clinical situations.
• Use only in the vascular territories, particle sizes, and patient populations specified in the current FDA-cleared labeling.

Clinical Applications

• Catheter-directed embolization of appropriately selected blood vessels.
• Blocking blood flow to a targeted vascular territory when embolization is part of the treatment plan.
• Use in interventional radiology procedures requiring a calibrated microsphere embolic agent.

Reported off-label uses

• Prostatic artery embolization for symptomatic benign prostatic hyperplasia or prostate-related bleeding, when performed outside the device's specific cleared labeling.
• Transarterial embolization or chemoembolization for selected liver tumors, including hepatocellular carcinoma, when not specifically covered by the current labeling.
• Embolization for selected musculoskeletal pain conditions, such as genicular artery embolization for knee osteoarthritis, in clinical practice or research settings.

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; the selected size must match the target vessel, catheter dimensions, flow conditions, and desired level of embolization.
• The particles are delivered through a compatible catheter under fluoroscopic or other image guidance. Careful preparation and suspension are important to reduce clumping or uneven delivery.
• Embolization can unintentionally block non-target vessels. Angiography is used to identify dangerous collateral pathways and confirm the final distribution.
• MRI safety and artifact information should be checked in the current device labeling; the microspheres are not necessarily the only factor because the treatment may also involve radiopaque markers, coils, catheters, or other implants.
• Contraindications and precautions include uncontrolled infection, significant uncorrectable bleeding risk, unsuitable vascular anatomy, severe contrast allergy when contrast cannot be used, and inability to safely access the target vessels.