Vascular Occlusion System Trufill Pushable Coils and Trufill Dcs Orbit Detachable Coil Sysem

FDA-Cleared Indications

• Embolization procedures requiring occlusion of selected blood vessels.
• Endovascular treatment in which a coil is used to reduce or stop blood flow in a targeted vessel.

Clinical Applications

• Coil embolization of a targeted blood vessel during an endovascular procedure.
• Occlusion of selected vessels associated with vascular abnormalities when the treating physician determines that coil embolization is appropriate.
• Use of pushable coils for manually delivered vascular occlusion.
• Use of detachable coils for controlled placement and release through a compatible microcatheter.

Reported off-label uses

• Treatment of selected cerebral aneurysms or vascular malformations when the specific device labeling does not identify that condition as an indication.
• Embolization of selected peripheral or visceral vessels outside the device's cleared 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 operator selects coil diameter, length and configuration based on the target vessel, blood-flow pattern and desired degree of occlusion.
• The coils are delivered through a compatible catheter or microcatheter; detachable coils permit position confirmation before release, while pushable coils are advanced into place and cannot be retrieved after deployment in the same way.
• The procedure is performed with fluoroscopic or angiographic imaging, usually through catheter access in the groin or wrist, depending on the treatment site.
• MRI safety and conditional-use requirements depend on the exact coil model, implanted configuration and current manufacturer labeling. The device identification and implant documentation should be reviewed before MRI.
• Potential risks include unintended vessel occlusion, coil migration, vessel injury, bleeding at the access site, infection, thromboembolism and recurrence or incomplete occlusion. Contraindications and warnings in the device instructions must be reviewed before use.