ClotTriever Thrombectomy System

FDA-Cleared Indications

• Mechanical removal of thrombus from the peripheral vasculature.
• Use in vessels of the peripheral venous system that are accessible with the device and compatible with its labeled size range.
• Intended for patients with venous thromboembolism when mechanical thrombectomy is selected as part of treatment.

Clinical Applications

• Mechanical thrombectomy for iliofemoral deep vein thrombosis.
• Mechanical thrombectomy for thrombosis involving other accessible peripheral veins, including selected upper-extremity veins.
• Removal of acute or chronic venous thrombus when anticoagulation alone is insufficient, unsuitable, or not the selected treatment.
• Catheter-based clot removal performed through venous access under fluoroscopic imaging.

Reported off-label uses

• Removal of thrombus from selected dialysis access circuits, including thrombosed arteriovenous fistulas or grafts, when used outside the device's labeled peripheral venous indication.
• Use in selected pulmonary embolism thrombectomy procedures; pulmonary embolism treatment may involve separate device configurations, labeling, or systems and should not be assumed to be covered by this clearance.

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 multiple catheter and sheath configurations; the selected size must match the target vessel, access route, and clot burden.
• The procedure is generally performed through femoral or other venous access under fluoroscopic guidance, with local anesthesia and moderate sedation or another planned anesthetic technique.
• Operators should evaluate bleeding risk, venous anatomy, thrombus age and extent, access-site complications, and the possibility of residual clot or embolization.
• MRI safety depends on the specific device components and whether they remain in the body; follow the current manufacturer labeling and MRI conditions rather than assuming the system is MRI safe.
• Anticoagulation, catheter-directed thrombolysis, surgical thrombectomy, or supportive treatment may be appropriate alternatives depending on the patient and clinical scenario.