FlowTriever Retrieval Aspiration System

FDA-Cleared Indications

• The FlowTriever Retrieval Aspiration System is indicated for the percutaneous removal of thromboemboli and thrombus from the peripheral vasculature.
• The system is indicated for the treatment of pulmonary embolism through percutaneous mechanical thrombectomy and aspiration.
• Use is limited to the vessels, patient populations, catheter sizes and configurations described in the applicable FDA-cleared labeling.

Clinical Applications

• Percutaneous mechanical thrombectomy for selected pulmonary embolism patients.
• Aspiration and mechanical removal of thrombus from the pulmonary arteries.
• Percutaneous removal of thrombus from selected peripheral vessels when the applicable FlowTriever configuration is indicated.
• Treatment in a hospital catheterization laboratory when rapid clot removal is needed or thrombolytic therapy is unsuitable or contraindicated.

Reported off-label uses

• Use for selected deep vein thrombosis in peripheral veins may occur in clinical practice, but the exact indication depends on the device configuration and current labeling.
• Use in other large-vessel venous thromboses outside the cleared indication has been reported, but it should be considered off-label and evaluated by an experienced specialist.

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 different catheter and sheath sizes; selection depends on vessel diameter, clot burden, access anatomy and the specific cleared product configuration.
• Access is commonly obtained through the femoral or internal jugular vein, with fluoroscopic guidance and large-bore venous access.
• Procedures require clinicians trained in large-bore catheter techniques, aspiration thrombectomy and management of potential bleeding or vascular injury.
• The device is not itself an MRI implant. MRI eligibility depends on any retained components, access-site materials and the current product-specific MRI labeling; the treating team should verify this before scanning.
• Potential complications include access-site bleeding, vascular injury, arrhythmia, pulmonary artery injury, blood loss, contrast-related complications and incomplete clot removal. Patient-specific contraindications and warnings are listed in the manufacturer's instructions for use.