Easi-Vue Embolic Microspheres System

FDA-Cleared Indications

• Embolization of blood vessels supplying hypervascular tumors and other abnormal tissue.
• Use in interventional radiology procedures where controlled vascular occlusion is indicated.
• Use as an embolic agent delivered through a catheter under imaging guidance.

Clinical Applications

• Transcatheter arterial chemoembolization for selected patients with inoperable liver cancer.
• Transarterial embolization of blood vessels supplying hypervascular tumors.
• Embolization of abnormal or unwanted arterial blood flow when vascular occlusion is clinically indicated.

Reported off-label uses

• Uterine fibroid embolization.
• Prostatic artery embolization for benign prostatic enlargement.
• Embolization of selected arteriovenous malformations or other hypervascular lesions.

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 delivered through a compatible angiographic catheter; catheter size and injection technique must match the product labeling and the target vessel.
• Particle size selection affects how distally the embolic material travels and should be based on the vascular anatomy, treatment goal and risk of non-target embolization.
• The product should be prepared, mixed and injected according to the manufacturer’s instructions to maintain a uniform suspension and reduce catheter obstruction.
• MRI safety and conditional labeling should be confirmed in the current instructions for use; the embolic material itself may not provide a reliable way to identify treated vessels on MRI.
• Contraindications and precautions include non-target vessel anatomy, uncorrectable bleeding risk, severe infection in the treatment area and inability to safely catheterize the target vessel.