ClotTriever Thrombectomy System

FDA-Cleared Indications

• Mechanical removal of thrombi from the peripheral vasculature.
• Use with compatible aspiration or thrombectomy techniques for removal of blood clots from peripheral blood vessels.
• Intended for adult patients when mechanical thrombectomy is clinically appropriate.

Clinical Applications

• Endovascular thrombectomy for selected iliofemoral deep vein thrombosis.
• Endovascular thrombectomy for selected upper-extremity deep vein thrombosis.
• Removal of thrombus from large peripheral veins using fluoroscopic guidance.
• DVT thrombectomy when rapid clot removal is considered appropriate in addition to, or instead of, anticoagulation alone.

Reported off-label uses

• Mechanical thrombectomy for selected pulmonary embolism cases using devices or configurations not specifically covered by the device labeling.
• Thrombectomy of dialysis fistula or graft thrombosis when the specific device configuration or indication is outside the 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 system includes catheter-based components in different sizes; device selection depends on vessel diameter, clot burden, access route, and anatomy.
• The procedure generally requires venous access, commonly through the popliteal, femoral, or jugular vein, with fluoroscopic imaging and local anesthesia with moderate sedation or general anesthesia when needed.
• Large-bore venous access may be required, and preparation should account for bleeding, blood loss, access-site complications, and the possibility of residual thrombus.
• Contraindications and precautions include unsuitable vessel size or anatomy, inability to receive the required anticoagulation, active bleeding risk, and other conditions listed in the current manufacturer instructions for use.
• MRI safety depends on the specific ClotTriever components and whether any components remain in the patient; the current device labeling should be checked before MRI.