ClotTriever Thrombectomy System

FDA-Cleared Indications

• Mechanical thrombectomy for the removal of thrombus from peripheral blood vessels.
• Use with aspiration to remove thrombus from peripheral vessels.
• Intended for use in patients with peripheral venous thromboembolism when mechanical clot removal is clinically appropriate.

Clinical Applications

• Mechanical thrombectomy for lower-extremity deep vein thrombosis, including iliofemoral DVT.
• Mechanical thrombectomy for upper-extremity venous thrombosis.
• Removal of thrombus associated with inferior vena cava filter thrombosis.
• Catheter-based removal of thrombus from peripheral veins when aspiration-assisted mechanical thrombectomy is selected.

Reported off-label uses

• Use in selected pulmonary embolism thrombectomy procedures, depending on the specific device configuration, anatomy, and applicable labeling.
• Removal of thrombus from dialysis fistulas or grafts when clinicians use the system outside its cleared peripheral venous indication.

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 sheath configurations; device selection depends on vessel diameter, clot location, access route, and thrombus burden.
• The procedure is usually performed through venous access, commonly from the popliteal, femoral, or internal jugular vein, with fluoroscopic or other imaging guidance.
• Large-bore venous access may be required, and aspiration can cause blood loss; operators should monitor hemodynamics and consider blood-conservation measures.
• Contraindications and precautions include inability to obtain suitable vascular access, severe vessel disease or injury, active bleeding risk, and anatomic conditions that make mechanical thrombectomy unsafe.
• MRI compatibility depends on the specific components and configuration. The device should be checked against the current manufacturer labeling before MRI, particularly while any component remains implanted.