Barricade Embolization Coil System

FDA-Cleared Indications

• Embolization or occlusion of selected blood vessels during endovascular procedures.
• Treatment of intracranial aneurysms and other vascular abnormalities that require embolization, as specified by the applicable FDA clearance.
• Use by appropriately trained clinicians with compatible delivery catheters and imaging guidance.

Clinical Applications

• Endovascular coiling of selected brain aneurysms.
• Embolization of vascular abnormalities in the neurovascular system.
• Planned vessel occlusion when reducing or stopping blood flow is part of the treatment strategy.

Reported off-label uses

• Embolization of selected peripheral or visceral vessels, such as vessels supplying tumors, gastrointestinal bleeding, or pelvic venous disorders, may be performed with coil devices in clinical practice when clinically appropriate. Use outside the cleared labeling is determined by the treating physician and should not be assumed to be FDA-cleared for this specific system.

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 different coil sizes and configurations; the treating physician selects the size based on the target vessel, aneurysm or vascular abnormality, blood-flow pattern, and catheter anatomy.
• Coils are delivered through a compatible microcatheter under fluoroscopic or other appropriate imaging guidance. Accurate catheter positioning and controlled deployment are essential.
• Patients may not be suitable for coil embolization because of unfavorable anatomy, inability to safely access the target vessel, active infection, contrast allergy, clotting abnormalities, or other procedure-specific risks.
• MRI safety depends on the exact device labeling and implanted configuration. The current device-specific instructions for use should be reviewed before MRI; do not assume that every coil system has identical MRI conditions.
• Potential complications include unintended vessel occlusion, coil migration or malposition, bleeding or vessel injury at the access site, thromboembolism, ischemia, infection, contrast reaction, and recurrence or incomplete occlusion of the treated abnormality.