Trufill Dcs Orbit Detachable Coil System

FDA-Cleared Indications

• Endovascular occlusion of cerebral aneurysms.
• Embolization of cerebral aneurysms using a detachable coil system.

Clinical Applications

• Catheter-based embolization of intracranial saccular aneurysms.
• Treatment of cerebral aneurysms when endovascular coiling is selected instead of surgical clipping.
• Placement of detachable platinum coils within an aneurysm to promote thrombosis and occlusion.

Reported off-label uses

• Embolization of selected non-aneurysmal intracranial vascular lesions has been reported for detachable coil systems, but this is outside the stated cerebral aneurysm indication and requires case-specific specialist judgment.

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 system is used with a compatible microcatheter and delivery system; catheter compatibility should be confirmed in the current instructions for use.
• Coil sizes and configurations are selected according to the aneurysm's width, depth, neck, and shape, as well as the parent vessel anatomy.
• Placement is performed under fluoroscopic or angiographic guidance, usually with general anesthesia or procedural sedation depending on the case.
• MRI safety and conditions depend on the specific device labeling and implanted configuration; the current MRI safety information should be verified before scanning.
• Potential risks include thromboembolism, aneurysm rupture, coil migration or protrusion, incomplete occlusion, recurrence, and complications related to vascular access or contrast.