Numen™ Helia Coil Embolization System; NumenFR™ Detachment System

FDA-Cleared Indications

• Embolization of neurovascular abnormalities, including intracranial aneurysms and arteriovenous malformations, when treatment with detachable coils is appropriate.
• The device is classified under FDA product code HCG for neurovascular embolization devices.

Clinical Applications

• Endovascular coil embolization of selected brain aneurysms.
• Embolization of selected intracranial vascular malformations.
• Treatment of other neurovascular lesions when the anatomy and labeling support detachable-coil embolization.

Reported off-label uses

• Embolization of selected extracranial or peripheral vascular lesions may be performed with coil devices of this type, but such use depends on the specific device labeling and is not established by this FDA record.

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 delivered through a compatible microcatheter; catheter inner-diameter and length requirements depend on the selected coil size.
• Available coil sizes, shapes and lengths should be checked in the current manufacturer instructions for use before treatment.
• Deployment is performed under fluoroscopic or other appropriate angiographic imaging, followed by electrical or mechanical detachment with the NumenFR system as specified by the labeling.
• MRI safety depends on the exact device configuration and the manufacturer’s current MR-conditional conditions. Confirm the MR labeling before scanning.
• Potential risks include thromboembolism, vessel perforation, hemorrhage, coil migration or misplacement, incomplete occlusion, recurrence, infection and complications related to vascular access or contrast.