Trufill Dcs Orbit Detachable Coil and Trufill Dcs Syringe or Trufill Dcs Syringe II Also Known as the Trufill Dcs Orbit

FDA-Cleared Indications

• Endovascular embolization of cerebral aneurysms.
• Use in the neurovascular circulation when detachable coil embolization is indicated.

Clinical Applications

• Endovascular coil embolization of intracranial cerebral aneurysms.
• Treatment of selected ruptured cerebral aneurysms after subarachnoid hemorrhage.
• Treatment of selected unruptured cerebral aneurysms.
• Filling and occluding an aneurysm sac to reduce blood flow and the risk of aneurysm rupture or rebleeding.

Reported off-label uses

• Embolization of selected nonaneurysmal intracranial vascular lesions may be reported in clinical practice, but this is not necessarily covered by the device labeling 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 includes a detachable platinum coil and a compatible delivery or detachment syringe system; compatibility should be confirmed before the procedure.
• Coil dimensions and shape are selected according to the aneurysm's size, neck, location, and the parent vessel anatomy.
• The device is delivered through a microcatheter under fluoroscopic or digital subtraction angiographic guidance, typically with local anesthesia and conscious sedation or general anesthesia depending on the case.
• MRI safety and conditional-use requirements depend on the exact device labeling and implanted coil configuration; the current manufacturer instructions should be reviewed before MRI.
• Contraindications and precautions include unsuitable vascular anatomy, inability to safely catheterize the target vessel, active infection, severe contrast allergy, and conditions that prevent anticoagulation or procedural imaging when these are clinically required.