M-Bolus Embolic Microspheres

FDA-Cleared Indications

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

Clinical Applications

• Catheter-directed embolization of blood vessels supplying hypervascular tumors.
• Catheter-directed embolization of arteriovenous malformations.
• Selective or superselective embolization when the operator needs to reduce blood flow to a defined vascular target.

Reported off-label uses

• Uterine artery embolization for symptomatic uterine fibroids.
• Embolization of selected bleeding vessels.
• Embolization of selected vascular malformations or abnormal shunts not specifically covered by the device labeling.

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 should be selected according to the target vessel, vascular anatomy and desired level of embolization.
• Accurate catheter placement and imaging guidance are important to limit unintended embolization of non-target vessels.
• Confirm catheter and delivery-system compatibility, and follow the device instructions for preparation, handling and injection.
• Potential complications include non-target embolization, ischemia, pain, infection, bleeding, vessel injury and allergic or inflammatory reactions.
• MRI safety and conditional labeling should be confirmed in the current manufacturer instructions; do not assume MRI compatibility from the device name alone.