ClotTriever Thrombectomy System

FDA-Cleared Indications

• Mechanical thrombectomy for the removal of thrombi from large peripheral vessels.
• Use in the peripheral vasculature under imaging guidance by appropriately trained clinicians.

Clinical Applications

• Removal of thrombus from large veins in patients with deep vein thrombosis.
• Treatment of iliofemoral venous thrombosis when mechanical clot removal is selected.
• Treatment of upper-extremity venous thrombosis when the anatomy and device specifications are appropriate.

Reported off-label uses

• Use in selected pulmonary embolism thrombectomy procedures has been reported in clinical practice, but pulmonary embolism treatment should be confirmed against the specific device labeling and applicable regulatory clearance.
• Use for thrombosed dialysis access circuits has been reported for mechanical thrombectomy devices, but the device's labeling, catheter compatibility and local protocols must be verified before use.

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 delivered through a venous access sheath, commonly obtained through the femoral or popliteal vein, with fluoroscopic or other appropriate imaging guidance.
• Available catheter and sheath sizes must match the target vessel, access sheath and procedural anatomy; operators should consult the current manufacturer instructions for use.
• The procedure may require local anesthesia with moderate sedation or another anesthesia plan, depending on clot burden, access site and patient condition.
• MRI safety and conditional-use information should be checked in the current device labeling; the procedure itself uses radiographic imaging rather than MRI.
• Important considerations include bleeding, access-site complications, vessel injury, embolization, contrast-related complications and recurrent thrombosis. Contraindications and warnings should be reviewed in the current instructions for use.