ClotTriever Bold Catheter

FDA-Cleared Indications

• Removal of thrombus from the peripheral vasculature.
• Mechanical thrombectomy for treatment of deep vein thrombosis in the venous system.
• Use with the ClotTriever System in adult patients when catheter-based removal of venous thrombus is clinically appropriate.

Clinical Applications

• Mechanical thrombectomy for acute or chronic lower-extremity deep vein thrombosis.
• Percutaneous removal of large venous thrombi to help restore blood flow.
• Treatment of symptomatic iliofemoral or femoropopliteal venous thrombosis when an endovascular procedure is selected.
• Venous clot removal in a hospital interventional radiology or vascular surgery setting.

Reported off-label uses

• Mechanical thrombectomy for selected upper-extremity or central venous thrombosis may be reported in clinical practice, but use depends on the specific device labeling, anatomy, and operator judgment.
• Use for selected pulmonary embolism or dialysis-access thrombosis may occur with related mechanical thrombectomy systems, but the ClotTriever BOLD catheter should not be assumed to be cleared for these applications without confirming the applicable 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 catheter is used with the ClotTriever System and must be matched to the target vessel size and compatible system components.
• The procedure is performed through percutaneous venous access, commonly through the popliteal, femoral, or jugular vein, using fluoroscopic or other image guidance.
• Mechanical thrombectomy can reduce or avoid the need for thrombolytic drugs, but anticoagulation and other adjunctive treatments may still be required.
• Potential complications include bleeding, venous injury or perforation, hematoma, recurrent thrombosis, embolization, infection, and contrast-related reactions.
• MRI safety and conditions depend on the specific catheter and whether it remains in the patient; the device is intended for temporary procedural use and should be evaluated according to its current manufacturer labeling before MRI.