ClotTriever Thrombectomy System

FDA-Cleared Indications

• Removal of thrombus from large peripheral veins in patients with venous thromboembolism.
• Mechanical thrombectomy with aspiration for treatment of peripheral venous thrombus, consistent with the device labeling and product code QEW.

Clinical Applications

• Mechanical thrombectomy for iliofemoral deep vein thrombosis.
• Mechanical thrombectomy for selected upper-extremity deep vein thrombosis.
• Catheter-based removal of thrombus from large peripheral veins when clot extraction is clinically indicated.
• Venous thrombectomy performed through percutaneous vascular access under imaging guidance.

Reported off-label uses

• Use in pulmonary embolism thrombectomy may be performed with related mechanical thrombectomy systems, but the specific FDA clearance summarized here is for peripheral venous thrombus and does not establish a pulmonary embolism indication for this record.
• Use in dialysis graft or fistula thrombectomy may occur with mechanical thrombectomy devices, but this record should not be interpreted as establishing a specific dialysis-access indication for the ClotTriever system.

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 used through percutaneous vascular access, commonly through the femoral or popliteal vein for lower-extremity DVT and through an upper-extremity venous access site for selected arm DVT.
• Available catheter and sheath sizes, working length, and vessel diameter requirements vary by system component; operators should confirm the current manufacturer instructions for use before the procedure.
• The procedure is performed with fluoroscopic or other image guidance and may require local anesthesia with moderate sedation or, in selected cases, general anesthesia.
• The device is intended for peripheral venous thrombectomy; it should not be assumed to be appropriate for arterial, intracranial, or pulmonary embolism treatment without a specific applicable indication and device labeling.
• MRI eligibility depends on the implanted or retained components and the manufacturer's current labeling. Patients should provide the device information to the MRI team before scanning.