UniPearls Embolic Microspheres

FDA-Cleared Indications

• Embolization of blood vessels to promote vascular occlusion when temporary or permanent reduction of blood flow is clinically indicated.
• Use by trained physicians with appropriate imaging guidance and catheter systems for embolization procedures.

Clinical Applications

• Embolization of selected vessels supplying hypervascular tumors.
• Embolization to control active or clinically significant bleeding.
• Embolization of uterine arteries for appropriately selected uterine conditions.
• Embolization of prostate arteries for appropriately selected prostate-related conditions.
• Embolization of other targeted vessels when vascular occlusion is indicated and consistent with the device labeling.

Reported off-label uses

• Genicular artery embolization for selected patients with symptomatic knee osteoarthritis.
• Middle meningeal artery embolization for selected patients with chronic subdural hematoma.
• Portal vein embolization before selected liver surgery to encourage growth of the future liver remnant.
• Embolization of selected vascular malformations or fistulas when particle embolization is considered appropriate.

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 selection depends on the target vessel, vascular anatomy, desired level of occlusion, and the clinical objective. Use only the sizes and delivery conditions specified in the current instructions for use.
• The microspheres must be compatible with the planned microcatheter, injection technique, contrast medium, and imaging system. Operators should avoid reflux and unintended embolization of non-target vessels.
• The product is intended for image-guided administration by clinicians trained in endovascular embolization. Angiography is typically used to map anatomy and confirm the treatment result.
• MRI safety should be determined from the current manufacturer labeling. Embolic microspheres are generally nonmetallic, but the catheter, coils, plugs, markers, or other implanted materials used during the same procedure may affect MRI conditions.
• Contraindications and precautions may include inability to catheterize the target vessel, significant uncorrectable coagulopathy, active infection in the treatment territory, severe contrast reaction risk, and vessels supplying critical non-target organs. Review the current FDA-cleared labeling before use.