ClotTriever Thrombectomy System

FDA-Cleared Indications

• Mechanical thrombectomy with aspiration for removing thrombus from the peripheral vasculature.
• Use in the peripheral venous system under fluoroscopic imaging guidance.
• FDA-cleared as a Class II peripheral mechanical thrombectomy device under product code QEW.

Clinical Applications

• Mechanical thrombectomy for lower-extremity deep vein thrombosis, including iliofemoral DVT.
• Removal of thrombus from upper-extremity veins in selected patients with venous thrombosis.
• Treatment of thrombus involving the inferior vena cava or an inferior vena cava filter.
• Catheter-based removal of peripheral venous thrombus when the treating clinician determines thrombectomy is appropriate.

Reported off-label uses

• Mechanical thrombectomy for selected pulmonary embolism cases using related or modified device configurations; this may not be covered by the specific FDA clearance and should not be assumed to be on-label.
• Thrombectomy of selected thrombosed dialysis grafts or fistulas using device configurations and techniques that may fall outside the specific 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 different catheter and device sizes; selection depends on vessel diameter, clot burden, access anatomy and the specific components being used.
• The device is typically introduced through venous access, such as the femoral or popliteal vein, and is used with fluoroscopic imaging.
• Access-site bleeding, vessel injury, embolization, residual thrombus and recurrent thrombosis are important procedural risks.
• MRI safety depends on the specific implanted or retained component and its labeling; the device should be removed unless the applicable instructions for use specifically permit MRI after placement.
• Contraindications and warnings in the current instructions for use should be reviewed, including unsuitable vessel anatomy, inability to obtain safe vascular access and conditions that make anticoagulation or endovascular treatment unsafe.