Penumbra Coil 400 Ruby Coil System Pod System

FDA-Cleared Indications

• Embolization of vessels in the peripheral and neurovascular systems.
• Treatment of vascular abnormalities, including aneurysms and arteriovenous malformations, when embolization is indicated.
• Control or reduction of blood flow in selected vessels during endovascular embolization procedures.

Clinical Applications

• Embolization of peripheral vascular abnormalities, including selected aneurysms and pseudoaneurysms.
• Embolization of arteriovenous malformations in appropriately selected vascular territories.
• Embolization to control bleeding from selected gastrointestinal, bronchial, pelvic, or visceral arteries.
• Embolization of selected intracranial vascular lesions when the device configuration and labeling support the procedure.

Reported off-label uses

• Embolization of selected venous abnormalities, such as varicoceles or ovarian venous insufficiency, when chosen by the treating physician.
• Embolization of selected portal or splenic venous or arterial branches as part of complex liver-directed procedures.
• Temporary or adjunctive vessel occlusion during selected thrombectomy, surgical, or hybrid procedures.

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 includes detachable embolization coils and a POD configuration in multiple diameters and lengths; coil selection depends on the target vessel, flow, anatomy, and desired packing or occlusion.
• The coils are delivered through a compatible catheter under fluoroscopic or other appropriate imaging guidance. Catheter inner diameter and system compatibility must be confirmed before use.
• MRI safety depends on the specific coil model and current manufacturer labeling. The exact device should be checked in the FDA-cleared instructions for use and MRI safety documentation before scanning.
• Potential complications include non-target embolization, vessel injury or perforation, ischemia, coil migration, incomplete occlusion, thrombosis, infection, bleeding, and complications related to contrast, catheterization, or sedation.
• Use is contraindicated or inappropriate when the target anatomy, vessel size, access route, coagulation status, infection risk, or inability to safely position the catheter does not meet the device labeling and clinical requirements.