Barricade Embolization Coil System
Blockade Medical
FDA Clearance Information
The Barricade Embolization Coil System was cleared through the FDA 510(k) pathway on February 13, 2014, by Blockade Medical. It is classified as a Class 2 device under product code HCG.
What It Is
FDA-Cleared Indications
- Occlusion of blood vessels in the peripheral vascular system.
- Occlusion of blood vessels in the neurovascular system.
- Embolization when a blood vessel must be intentionally blocked to manage an aneurysm or other vascular abnormality.
Clinical Applications
- Endovascular treatment of selected cerebral aneurysms.
- Embolization of selected peripheral aneurysms or pseudoaneurysms.
- Occlusion of selected abnormal peripheral or neurovascular blood vessels.
- Embolization performed through a microcatheter when targeted vessel blockage is clinically indicated.
Reported off-label uses
- Embolization of selected arteriovenous malformations or fistulas.
- Control of selected gastrointestinal, bronchial, or visceral arterial bleeding.
- Preoperative or staged portal-vein embolization before liver surgery.
- Treatment of selected pelvic venous disorders, including varicocele or ovarian-vein reflux.
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 diameters and lengths; coil selection depends on the target vessel, aneurysm or abnormality size, blood-flow conditions, and the desired packing density.
- Delivery is performed through a compatible microcatheter under fluoroscopic or other angiographic imaging guidance. Compatibility must be confirmed for the specific coil and catheter combination.
- Correct sizing and stable placement are important because undersizing can cause migration, while excessive oversizing can make deployment difficult or injure the vessel.
- MRI safety depends on the exact Barricade coil model and its current labeling. The implant’s MRI conditions should be verified before scanning; patients should provide the device identification information to the MRI team.
- Risks include non-target embolization, coil migration or displacement, vessel injury, thrombosis, ischemia, bleeding, infection, allergic reaction to contrast, and recurrence or incomplete occlusion. Contraindications and precautions should be reviewed in the manufacturer’s instructions for use.
Procedures that use this device
Frequently Asked Questions
What is the Barricade Embolization Coil System used for?
It is used to occlude blood vessels in the treatment of aneurysms and other vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the occlusion of blood vessels in the peripheral and neurovascular systems.