The Trufill Dcs Detachable Coil System the Trufill Dcs Orbit Detachable Coil System

FDA-Cleared Indications

• Embolization of cerebral aneurysms.
• Endovascular occlusion of intracranial aneurysms using detachable embolization coils.

Clinical Applications

• Endovascular treatment of selected ruptured cerebral aneurysms.
• Endovascular treatment of selected unruptured cerebral aneurysms.
• Packing an intracranial aneurysm with detachable coils to promote occlusion.
• Use during catheter-based neurointerventional embolization procedures.

Reported off-label uses

• Embolization of selected non-aneurysmal intracranial vascular lesions may be reported in clinical practice, but this is outside the stated cerebral aneurysm indication and requires physician 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 includes detachable platinum coils in multiple sizes and configurations; coil selection depends on aneurysm width, height, neck, shape and the planned packing strategy.
• The coil is delivered through a compatible microcatheter under fluoroscopic and angiographic guidance, usually through arterial access in the groin or wrist.
• The procedure may require general anesthesia or conscious sedation, depending on aneurysm location, patient condition and institutional practice.
• MRI safety depends on the exact coil system, labeling and scanner conditions; the implant card and current manufacturer instructions should be reviewed before MRI.
• Contraindications and limitations include unsuitable aneurysm anatomy, inability to safely access the target vessel, allergy or intolerance to relevant materials or contrast, and clinical conditions that make endovascular treatment unsafe.