Penumbra Smart Coil

FDA-Cleared Indications

• Embolization of intracranial aneurysms and other neurovascular lesions requiring vessel occlusion.
• Use with a compatible microcatheter and delivery system for controlled placement of embolization coils.

Clinical Applications

• Endovascular coil embolization of selected intracranial aneurysms.
• Embolization of selected cerebral or neurovascular vascular lesions requiring occlusion.
• Targeted occlusion of abnormal neurovascular blood flow under fluoroscopic guidance.

Reported off-label uses

• Embolization of selected arteriovenous fistulas or malformations outside the specific FDA-cleared labeling, based on physician judgment and available clinical evidence.
• Embolization of selected extracranial or peripheral vessels with compatible coil systems, when used outside the device's neurovascular 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 coil must be matched to the target vessel or aneurysm and delivered through a compatible microcatheter; available coil dimensions and configuration vary by model.
• Placement is performed with fluoroscopic angiography, generally through arterial access such as the femoral or radial artery, with anesthesia or sedation based on the procedure.
• Contraindications and precautions include inability to safely catheterize the target vessel, unsuitable vessel anatomy, active infection, severe contrast allergy, or bleeding and clotting disorders that cannot be corrected.
• MRI safety depends on the specific SMART COIL model and labeling. Confirm the exact implant and follow its current MR-conditional conditions before MRI.
• Coils are intended to remain implanted permanently. Additional treatment or retreatment may be needed if blood flow persists or the lesion recanalizes.