Vivorte Trabexus Eb

FDA-Cleared Indications

• Embolization procedures intended to occlude blood vessels.
• Use in patients for whom targeted vascular occlusion is clinically indicated.

Clinical Applications

• Catheter-directed embolization of selected blood vessels.
• Treatment of vascular abnormalities requiring controlled vessel occlusion.
• Reduction or interruption of blood flow to a targeted vascular territory.

Reported off-label uses

• Embolization of hypervascular tumors in clinical situations not specifically described in the available FDA indication text.
• Embolization of arteriovenous malformations when the specific anatomy or clinical indication is outside the product 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

• The available record does not provide the device's labeled microsphere size range; clinicians should confirm particle sizes and the intended vascular territory in the current instructions for use.
• The microspheres must be compatible with the selected delivery catheter and prepared and administered according to the manufacturer's instructions.
• Embolization requires image guidance and specialized training to reduce the risk of non-target embolization, vessel injury and ischemia.
• MRI safety information is not provided in the supplied FDA record; review the current labeling before MRI.
• Contraindications, warnings and precautions should be taken from the current manufacturer labeling rather than inferred from the product category.