Embozene Color-Advanced Microspheres

FDA-Cleared Indications

• Embolization of prostatic arteries for the treatment of symptoms associated with benign prostatic hyperplasia in adult men.

Clinical Applications

• Prostatic artery embolization for benign prostatic hyperplasia

Reported off-label uses

• Uterine artery embolization for symptomatic uterine fibroids
• Transcatheter arterial embolization of tumors, including use with transcatheter arterial chemoembolization
• Arterial embolization to control bleeding in selected clinical situations

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 microspheres are available in different calibrated size ranges; the selected size depends on the target vessel, blood flow, vascular anatomy and treatment goal.
• They are delivered through a compatible angiographic catheter under fluoroscopic or other x-ray imaging guidance. Catheter compatibility and preparation should follow the current product instructions for use.
• Embolic microspheres are intended for permanent vessel occlusion and should not be injected into arteries supplying the spinal cord, brain or other unintended organs.
• MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; the implanted microspheres themselves are not typically the primary MRI limitation, but other devices and coils used during embolization may matter.
• Contraindications and precautions include uncorrectable bleeding disorders, active infection in the treatment area, significant non-target collateral vessels and allergy to relevant contrast or procedural materials.