Barricade Embolization Coil System

FDA-Cleared Indications

• Occlusion of blood vessels in the peripheral vascular system during embolization procedures.
• Occlusion of blood vessels in the neurovascular system during embolization procedures.
• Use in aneurysms and other vascular abnormalities when controlled blockage of blood flow is clinically indicated.

Clinical Applications

• Embolization of selected intracranial aneurysms.
• Embolization of selected peripheral vascular aneurysms or pseudoaneurysms.
• Occlusion of selected peripheral arteries or veins when blood flow must be controlled or stopped.
• Embolization of selected neurovascular or peripheral vascular abnormalities requiring vessel occlusion.

Reported off-label uses

• Embolization of arteriovenous malformations or fistulas when the treating specialist determines that coil occlusion is appropriate.
• Embolization for selected gastrointestinal, bronchial, pelvic, or visceral bleeding when coil embolization is clinically appropriate.

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 system is available in multiple coil sizes and lengths; selection depends on the target vessel, aneurysm or abnormality, flow, and anatomy.
• Coils are delivered through a compatible microcatheter under fluoroscopic or angiographic imaging. The specific catheter and delivery-system requirements should be confirmed in the current instructions for use.
• Placement should be performed by clinicians trained in endovascular embolization, with angiography available to confirm positioning and vessel occlusion.
• MRI safety depends on the exact coil configuration and current labeling. Patients should provide the implant information before MRI, and the radiology team should verify the device's MR status.
• Potential risks include unintended vessel occlusion, coil migration or repositioning, bleeding at the access site, vessel injury, thromboembolism, infection, allergic reaction to contrast, and procedure-related neurologic or ischemic complications.