ClotTriever XL Catheter

FDA-Cleared Indications

• Mechanical removal of thrombus from the peripheral vasculature.
• Use in vessels with a diameter of at least 6 mm.
• Intended for patients with venous thromboembolism when mechanical thrombectomy is clinically appropriate.

Clinical Applications

• Mechanical thrombectomy for extensive lower-extremity deep vein thrombosis involving large peripheral veins.
• Removal of thrombus from the iliac and femoral venous systems.
• Image-guided treatment of large clot burdens when clinicians choose mechanical thrombectomy rather than, or in addition to, catheter-directed thrombolytic therapy.
• Treatment of venous thrombosis in patients for whom thrombolytic drugs may carry substantial bleeding risk, when consistent with clinical judgment and labeling.

Reported off-label uses

• Thrombectomy for selected thrombosed dialysis grafts or fistulas, depending on the specific device labeling, anatomy, and institutional practice.
• Mechanical thrombectomy in selected pulmonary embolism cases using devices and configurations not specifically covered by this product's peripheral-vascular 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 catheter is intended for large peripheral vessels; vessel diameter, access anatomy, clot extent, and the available working sheath must be assessed before treatment.
• Placement and clot removal are performed with fluoroscopic imaging through vascular access, commonly through the popliteal, femoral, or jugular venous route depending on the anatomy.
• The procedure requires clinicians trained in venous mechanical thrombectomy and management of potential complications such as bleeding, vessel injury, embolization, or residual thrombus.
• The device is not a permanent implant and is removed after the procedure. MRI conditions should be confirmed in the current Instructions for Use; do not assume MRI safety without reviewing the device labeling.
• Anticoagulation, catheter-directed thrombolysis, surgical thrombectomy, angioplasty, stenting, or observation may be appropriate alternatives or adjuncts depending on the patient and cause of thrombosis.