Trufill Dcs Detachable Coil and Frufill Dcs Syringe Also Known as the Trufill Dcs Detachable Coil System

FDA-Cleared Indications

• Embolization of cerebral aneurysms.
• Use as a neurovascular embolization device under the FDA-cleared 510(k) classification for this device type.

Clinical Applications

• Endovascular coil embolization of intracranial cerebral aneurysms.
• Treatment of selected ruptured cerebral aneurysms to reduce the risk of repeat bleeding.
• Treatment of selected unruptured cerebral aneurysms when preventive occlusion is considered appropriate.
• Placement of detachable platinum coils through a microcatheter to promote aneurysm thrombosis and occlusion.

Reported off-label uses

• Coil embolization of selected non-aneurysmal intracranial vascular lesions has been reported in clinical practice, but these applications may be outside the device's FDA-cleared labeling and require 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 detachable platinum coils and a delivery syringe; coil dimensions and delivery compatibility must be selected for the aneurysm and the intended microcatheter.
• The procedure is performed through catheter access, commonly from the femoral or radial artery, with fluoroscopic angiographic guidance and local anesthesia with sedation or general anesthesia depending on the case.
• Contraindications and precautions include inability to safely access the target vessel, unfavorable aneurysm anatomy, active infection, severe contrast allergy, or a bleeding or clotting disorder that cannot be corrected.
• MRI safety depends on the specific coil and labeling. The treating team and MRI department should verify the exact device's current MR-conditional conditions before scanning.
• Potential complications include thromboembolism, aneurysm rupture, hemorrhage, vessel injury, coil migration or compaction, incomplete occlusion, recurrence, contrast reaction, and access-site complications.