Barricade Embolization Coil System

FDA-Cleared Indications

• Occlusion of blood vessels in the neurovascular system during embolization procedures.
• Occlusion of blood vessels in the peripheral vascular system during embolization procedures.
• Use in the treatment of vascular conditions requiring intentional vessel blockage, when selected by the treating physician.

Clinical Applications

• Endovascular embolization of selected cerebral or other neurovascular vessels.
• Embolization of selected peripheral blood vessels.
• Treatment of aneurysms or vascular malformations when vessel occlusion is part of the labeled treatment plan.

Reported off-label uses

• Embolization of uterine arteries for symptomatic fibroids.
• Embolization of prostatic arteries for benign prostatic hyperplasia.
• Embolization of visceral, pelvic, or gastrointestinal arteries for bleeding or aneurysm management.
• Embolization of gonadal or pelvic veins for varicocele or pelvic venous disorders.

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

• Coils are available in different diameters and lengths; the treating physician selects the size based on the target vessel, anatomy, and desired packing or occlusion.
• The coil must be compatible with the delivery catheter and deployment system. Device instructions for use should be followed for preparation, positioning, and release.
• Placement is performed under fluoroscopic or other appropriate angiographic imaging, usually through catheter access in the femoral or radial artery, depending on the procedure.
• MRI safety depends on the specific coil configuration and the manufacturer's current labeling. The device record alone does not establish that every Barricade coil is MR Safe or MR Conditional; confirm the exact model and MRI conditions before scanning.
• Potential risks include unintended vessel occlusion, coil migration or misplacement, vessel injury, bleeding or hematoma at the access site, ischemia, infection, allergic reaction to contrast, and procedure-specific neurologic or organ complications.