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Barricade Embolization Coil System
Blockade Medical
Summary: The Barricade Embolization Coil System is a medical device used to occlude blood vessels, typically in the treatment of aneurysms. It is primarily used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K142513 ↗
Decision Date ?
November 13, 2014
Product Code ?
HCG Device, Neurovascular Embolization
Device Class ?
Class 2
Evidence ?
0 studies
The Barricade Embolization Coil System was cleared through the FDA's 510(k) pathway on November 13, 2014. It is manufactured by Blockade Medical and classified as a Class 2 device.
What It Is
The Barricade Embolization Coil System is designed to occlude or block blood flow in targeted vessels. It consists of a series of coils that are deployed into a blood vessel to create a physical barrier, promoting clot formation and vessel occlusion. This device is particularly useful in treating cerebral aneurysms by preventing blood flow into the aneurysm sac, thereby reducing the risk of rupture.
FDA-Cleared Indications
- Embolization and occlusion of blood vessels in the neurovascular system.
- Treatment of intracranial aneurysms and other vascular abnormalities when targeted vessel occlusion is clinically appropriate.
Clinical Applications
- Endovascular coiling of selected brain aneurysms.
- Occlusion of targeted neurovascular vessels or vascular lesions.
- Embolization of abnormal cerebral or other neurovascular blood flow under imaging guidance.
Reported off-label uses
- Embolization of selected peripheral or visceral arteries when a clinician determines that a neurovascular coil is appropriate for the anatomy and clinical situation.
- Treatment of selected non-neurovascular aneurysms, pseudoaneurysms, arteriovenous malformations, or active bleeding when used outside the device's cleared labeling.
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 configurations; selection depends on the target vessel or aneurysm, vascular anatomy, and desired packing or occlusion.
- Deployment is performed through a compatible microcatheter using fluoroscopic angiographic guidance. Operators should confirm catheter and delivery-system compatibility before use.
- The procedure may require local anesthesia with conscious sedation or general anesthesia, depending on the lesion, access route, and patient condition.
- MRI safety and conditions depend on the specific device configuration and current manufacturer labeling. The implanted coil should be identified and its MRI conditions confirmed before scanning.
- Potential contraindications and risks include inability to safely catheterize the target vessel, severe contrast allergy or kidney disease requiring special planning, vessel perforation, thromboembolism, hemorrhage, infection, coil migration, and incomplete or recurrent occlusion.
Procedures that use this device
Frequently Asked Questions
What is the Barricade Embolization Coil System used for?
It is used to occlude blood vessels, primarily in the treatment of cerebral aneurysms.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for the occlusion of blood vessels, such as in the treatment of cerebral aneurysms.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.