ClotTriever Thrombectormy System ClotTriever Catheter ClotTriever Sheath

FDA-Cleared Indications

• Removal of thrombus from the peripheral vasculature.
• Mechanical thrombectomy with aspiration for treatment of peripheral vascular thrombus.
• Use with compatible access sheaths and catheters under imaging guidance by trained physicians.

Clinical Applications

• Mechanical thrombectomy for iliofemoral and other large-vessel deep vein thrombosis.
• Removal of thrombus from the peripheral venous system when rapid clot extraction is clinically indicated.
• Treatment of selected peripheral vascular occlusions using catheter-based thrombus capture and aspiration.
• Thrombectomy procedures performed through venous access, commonly using fluoroscopic or other imaging guidance.

Reported off-label uses

• Mechanical thrombectomy for pulmonary embolism using ClotTriever components or related device configurations may be reported in clinical practice, but the specific indication depends on the cleared device labeling and should not be assumed from this record.
• Removal of thrombus from dialysis access circuits may be performed with compatible thrombectomy systems, although use of this specific system should be verified against current labeling and institutional policy.

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 a mechanical thrombectomy catheter and compatible sheath components; available sizes and lengths depend on the specific ClotTriever configuration and target vessel.
• Access is commonly obtained through the femoral or popliteal vein for lower-extremity deep vein thrombosis, with fluoroscopy and venography used to plan and confirm treatment.
• The catheter must be advanced over an appropriate guidewire and through a vessel large enough to accommodate the selected sheath and device; vessel anatomy, clot location, and access-site conditions affect device selection.
• The procedure may be performed with local anesthetic and moderate sedation or with general anesthesia, depending on clot burden, treatment location, and patient condition.
• MRI safety and conditional-use requirements are configuration-specific. The exact catheter, sheath, and accessory components should be checked in the current manufacturer instructions before MRI; the system is not an implanted device intended to remain in the body.