Itc Bunji Platinum Embolization Coil

FDA-Cleared Indications

• Embolization and occlusion of selected blood vessels during endovascular procedures.
• Use in the treatment of neurovascular abnormalities where blocking blood flow is clinically indicated.
• Use by appropriately trained physicians with compatible catheter systems and imaging guidance.

Clinical Applications

• Endovascular occlusion of selected intracranial or other neurovascular vessels.
• Embolization of aneurysms or vascular abnormalities when permanent vessel blockage is required.
• Catheter-based treatment of selected arteriovenous vascular malformations.
• Adjunctive embolization in procedures intended to reduce or stop blood flow to a targeted vascular lesion.

Reported off-label uses

• Embolization of selected visceral, pelvic, or peripheral arterial branches when clinicians use a neurovascular coil for a suitable vessel and clinical situation.
• Treatment of selected pseudoaneurysms outside the neurovascular system.
• Embolization of collateral or feeding vessels in selected bleeding or tumor 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 coil size, length, and configuration must match the target vessel, lesion, and desired degree of occlusion.
• The coil is delivered through a compatible catheter under fluoroscopic or other appropriate imaging guidance by trained physicians.
• Device compatibility, catheter inner diameter, vessel tortuosity, and the planned deployment technique should be confirmed before use.
• Potential complications include non-target embolization, vessel injury, thrombosis, bleeding, infection, and incomplete or unintended occlusion.
• MRI safety should be confirmed from the current device labeling and institutional MRI policy before scanning; do not assume MRI compatibility from the platinum material alone.