Penumbra Coil System Penumbra Coil 400

FDA-Cleared Indications

• Embolization of intracranial aneurysms.
• Embolization of other neurovascular abnormalities, including arteriovenous fistulas, when treatment with a detachable coil is appropriate.
• Mechanical occlusion of blood vessels during endovascular embolization procedures.

Clinical Applications

• Endovascular coiling of selected brain aneurysms.
• Embolization of selected intracranial or other neurovascular arteriovenous fistulas.
• Targeted vessel occlusion when an interventional specialist needs to stop or reduce blood flow to a defined vascular area.

Reported off-label uses

• Embolization of selected peripheral visceral or pelvic arteries, such as treatment of aneurysms, pseudoaneurysms, or active bleeding, depending on the specific coil configuration and clinical judgment.
• Embolization of selected arteriovenous malformations outside the central nervous 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 includes detachable coils in multiple diameters and lengths; the treating physician selects the size based on the target vessel, aneurysm or fistula anatomy, and desired packing density.
• Coil delivery requires a compatible microcatheter and fluoroscopic or angiographic imaging. Vessel access is commonly obtained through the femoral or radial artery, depending on the procedure.
• Patients with infection at the access site, severe bleeding or clotting problems, or anatomy that cannot safely accommodate the catheter and coil may not be candidates.
• MRI safety depends on the exact coil model, implantation conditions, and the manufacturer's current labeling. The implant identification card and official instructions for use should be reviewed before MRI.
• The coil is intended to remain permanently implanted. Possible complications include bleeding, vessel injury, clot formation, unintended vessel occlusion, coil migration, aneurysm recurrence, infection, and procedure-related neurologic injury.