Gelspheres Beadblock Compressible Microspheres

FDA-Cleared Indications

• Embolization of hypervascular tumors.
• Embolization of arteriovenous malformations.

Clinical Applications

• Catheter-directed embolization of selected hypervascular tumors.
• Catheter-directed embolization of selected arteriovenous malformations.
• Targeted occlusion of abnormal vessels when the treating physician determines that embolization is appropriate under the device labeling.

Reported off-label uses

• Uterine fibroid embolization.
• Embolization of selected bleeding arteries.
• Embolization of vascular malformations or tumors in clinical situations outside the specific FDA-cleared indication.

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 operator selects microsphere size based on the target vessel, vascular anatomy, flow rate and desired level of occlusion.
• The particles are compressible and are delivered through a compatible catheter or microcatheter under fluoroscopic imaging.
• Careful angiography is required to confirm the target vessels and reduce the risk of non-target embolization.
• MRI safety depends on the complete implanted or retained device system and current product labeling; the microspheres should be reviewed with the interventional team and MRI facility before scanning.
• Contraindications and precautions may include an inability to safely catheterize the target vessel, severe uncorrectable coagulopathy, active infection at the access site and significant risk of reflux into non-target arteries.