FlowTriever Retrieval Aspiration System FlowTriever Catheters Triever 16 Triever 20 Triever 20 Curve Triever 24

FDA-Cleared Indications

• Removal of thrombus from the peripheral vasculature.
• Treatment of venous thromboembolism when mechanical thrombectomy is clinically appropriate.
• Use with the FlowTriever system catheters, including Triever 16, Triever 20, Triever 20 Curve, and Triever 24, according to the device labeling and applicable vessel anatomy.

Clinical Applications

• Mechanical thrombectomy for selected pulmonary embolism cases.
• Mechanical thrombectomy for selected lower-extremity deep vein thrombosis.
• Removal of thrombus from large peripheral veins and other peripheral vascular segments.
• Catheter-based thrombus removal when aspiration and mechanical retrieval are selected instead of, or in addition to, medication or surgery.

Reported off-label uses

• Removal of thrombus or obstructive material in complex congenital heart anatomy, including selected Fontan conduit obstructions, has been reported in clinical practice.
• Removal of selected intracardiac or valvular thrombotic material has been described in case reports and series but is not established as a general FDA-cleared 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

• Available catheter sizes include Triever 16, Triever 20, Triever 20 Curve, and Triever 24; the appropriate size depends on vessel diameter, thrombus burden, access route, and the specific device instructions for use.
• The system is introduced through a vascular access sheath and used with fluoroscopic imaging. Treatment commonly requires venous access, often through the common femoral or internal jugular vein, depending on the target.
• Large-bore aspiration can cause blood loss, hypotension, vascular injury, hemolysis, arrhythmia, or other procedure-related complications. Patient selection and hemodynamic monitoring are important.
• The device is not a permanent implant. MRI status and any conditions for MRI use should be checked in the current manufacturer labeling before scanning.
• Contraindications, warnings, vessel-size requirements, sheath compatibility, anticoagulation, and retrieval technique should be reviewed in the current FDA-cleared instructions for use. Alternative treatment may include anticoagulation, thrombolytic medication, catheter-directed thrombolysis, or surgery.