Callispheres Embolic Microspheres 8spheres Embolic Microspheres

FDA-Cleared Indications

• Embolization of uterine fibroids
• Use as an embolic agent during interventional radiology procedures when indicated for uterine fibroid embolization

Clinical Applications

• Uterine fibroid embolization to reduce blood flow to symptomatic fibroids
• Transcatheter delivery of embolic microspheres through a catheter into arteries supplying uterine fibroids

Reported off-label uses

• Embolization of hypervascular tumors, including liver tumors, in selected interventional oncology procedures
• Use during transcatheter arterial chemoembolization for hepatocellular carcinoma
• Embolization of other bleeding or hypervascular lesions, depending on clinical judgment and applicable regulations

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

• Microsphere size should be selected according to the target-vessel diameter, vascular anatomy, and desired level of embolization.
• The particles are delivered through a compatible catheter under imaging guidance, commonly fluoroscopy and angiography.
• Clinicians should review the product labeling for preparation, suspension, injection technique, catheter compatibility, and warnings before use.
• Embolization requires assessment of non-target blood-flow pathways because unintended particle delivery can injure healthy tissue.
• MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; do not assume MRI compatibility without that documentation.