Embozene Color-Advanced Microspheres Embozene Opaque Non-Colored Microspheres

FDA-Cleared Indications

• Embolization of blood vessels supplying uterine fibroids.
• Embolization of selected hypervascular tumors or other vascular targets when clinically appropriate under the device labeling.
• Embolization of abnormal vascular formations covered by the cleared indication.

Clinical Applications

• Uterine fibroid embolization to reduce blood flow to fibroids.
• Catheter-directed embolization of selected hypervascular tumors.
• Embolization of selected abnormal vascular formations.
• Targeted occlusion of blood vessels when the treating physician determines that the device and particle size are appropriate.

Reported off-label uses

• Embolization of selected bleeding vessels, such as gastrointestinal or traumatic hemorrhage, using microspheres when clinically appropriate.
• Transarterial embolization or chemoembolization of tumors outside the specific FDA-cleared indication.
• Embolization of selected arteriovenous malformations or fistulas.

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 microsphere sizes must be matched to the target-vessel diameter, vascular anatomy, and desired level of occlusion.
• The particles are delivered through an angiographic catheter or microcatheter under fluoroscopic imaging; reflux into non-target arteries must be avoided.
• Use requires careful angiography to identify collateral vessels and blood supply to organs that should not be embolized.
• MRI compatibility depends on the final implanted material and the complete treatment setup; the device labeling and current manufacturer instructions should be reviewed before MRI.
• Potential contraindications and precautions include uncorrectable coagulopathy, severe contrast allergy, active infection in the access or treatment field, and vessels too small or anatomically unsuitable for safe delivery.