Vascular Occlusion System Trufill Pushable Coils and Trupush Coil Pusher

FDA-Cleared Indications

• Embolization of selected blood vessels to reduce or stop blood flow.
• Treatment of aneurysms and other vascular abnormalities requiring vessel occlusion.

Clinical Applications

• Catheter-based embolization of a selected artery or other blood vessel.
• Occlusion of a vascular abnormality when blocking blood flow is part of treatment.
• Embolization treatment for selected aneurysms.
• Embolization treatment for selected arteriovenous malformations or other abnormal vascular connections.

Reported off-label uses

• Control of selected acute bleeding when coil embolization is clinically appropriate.
• Embolization of selected hypervascular tumors or tumor-feeding vessels.

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 operator selects coil diameter and length according to the target vessel or vascular sac, blood-flow conditions, and the desired degree of occlusion.
• The coil must be compatible with the delivery catheter and Trupush coil pusher; device-specific instructions for use should be checked before the procedure.
• Pushable coils require careful positioning because they are not generally repositioned after deployment in the same way as detachable coils. Coil migration or non-target embolization is a procedural risk.
• The procedure is performed with fluoroscopic imaging, usually through catheter access in the groin, wrist, or another appropriate vessel, with local anesthesia and sedation or general anesthesia depending on the case.
• MRI safety depends on the exact coil and labeling. The device's current instructions for use and MR conditions should be reviewed before MRI; the implant should not be assumed to be universally MR safe.