Merit Siege Vascular Plug

FDA-Cleared Indications

• Occlusion of vascular structures in patients who require embolization.
• Use in selected vascular structures where blocking blood flow is clinically indicated.

Clinical Applications

• Catheter-based embolization of selected vascular structures.
• Occlusion of abnormal or unwanted blood flow before or during treatment of a vascular condition.
• Embolization procedures performed in interventional radiology, vascular surgery, or interventional cardiology settings when the target vessel is suitable for a vascular plug.

Reported off-label uses

• Embolization of selected visceral artery aneurysms or pseudoaneurysms when the anatomy and device specifications are appropriate.
• Embolization of internal iliac artery branches in selected pelvic vascular procedures.
• Embolization of ovarian or gonadal veins in selected cases of pelvic venous disorders or varicocele.

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 plug is available in multiple sizes; selection depends on the target vessel diameter, length, flow, and anatomy. Oversizing requirements should follow the current manufacturer instructions for use.
• It is delivered through a compatible catheter under fluoroscopic or other appropriate imaging guidance. Vessel access is commonly obtained through the femoral or another suitable arterial or venous access site.
• The device is intended to produce vascular occlusion and should not be placed where unintended blockage could cause clinically significant ischemia.
• Review the current instructions for use for contraindications, catheter compatibility, deployment technique, retrieval limits, and MRI conditions. MRI safety should be confirmed for the specific device and scanning conditions before imaging.
• Potential complications include non-target embolization, device migration, vessel injury, bleeding or hematoma at the access site, infection, ischemia, and incomplete occlusion.