ClotTriever Thrombectomy System

FDA-Cleared Indications

• Mechanical thrombectomy for removing thrombi from the peripheral vasculature.
• Use with aspiration to remove thrombus from peripheral blood vessels.
• FDA-cleared as a Class II peripheral mechanical thrombectomy device under product code QEW and 21 CFR 870.5150.

Clinical Applications

• Mechanical thrombectomy for iliofemoral deep vein thrombosis.
• Mechanical thrombectomy for selected upper-extremity deep vein thrombosis.
• Catheter-based removal of peripheral venous thrombus when rapid clot reduction is clinically indicated.
• Use as part of an endovascular treatment strategy that may also include anticoagulation, compression therapy or other medical treatment.

Reported off-label uses

• Mechanical thrombectomy for selected thrombotic occlusions in dialysis grafts or fistulas, depending on the specific device configuration and labeling.
• Use in selected pulmonary embolism procedures with related thrombectomy systems or configurations should not be assumed to be covered by this device's peripheral venous 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 is available in different catheter and sheath configurations; selection depends on vessel diameter, thrombus location and access anatomy.
• The procedure generally requires venous access, fluoroscopic imaging and local anesthesia with moderate sedation or another anesthetic plan selected by the treating team.
• Potential risks include bleeding, vascular injury, venous perforation, embolization, recurrent thrombosis, contrast reaction and complications at the access site.
• MRI safety and conditions depend on the specific ClotTriever components used; the device labeling should be checked before MRI, and implanted or retained components must be identified.
• Contraindications and precautions include unsuitable vessel size or anatomy, inability to obtain safe access, active bleeding or a condition that makes anticoagulation or endovascular treatment unsafe.