Indigo Aspiration System - Modified 110 Aspiration Tubing

FDA-Cleared Indications

• Mechanical thrombectomy or embolectomy for the removal of thrombus or emboli from peripheral arteries and veins.
• Intended for use in the peripheral vasculature, including vessels outside the coronary and cerebral circulations.
• The system is used with compatible aspiration catheters and accessories selected for the target vessel and clot.

Clinical Applications

• Aspiration thrombectomy for acute lower-extremity arterial occlusion or limb ischemia.
• Aspiration thrombectomy for peripheral venous thromboembolism, including selected lower-extremity deep vein thrombosis.
• Removal of thrombus from dialysis grafts or fistulas when used with compatible system components and within their labeling.
• Removal of peripheral emboli or thrombus when catheter-based restoration of blood flow is indicated.

Reported off-label uses

• Aspiration thrombectomy for selected pulmonary embolism cases, depending on the specific catheter configuration and labeling applicable to the system.
• Aspiration thrombectomy in other noncerebral vascular beds beyond the device's specifically labeled indications, as reported in clinical practice.

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 modified 110 aspiration tubing is an accessory within the Indigo system; the appropriate aspiration catheter, separator, tubing and pump configuration must be matched according to the current manufacturer instructions for use.
• Use requires vascular access, fluoroscopic or other appropriate imaging guidance, and anticoagulation or thrombolytic treatment when clinically indicated.
• Potential complications include bleeding, access-site hematoma, vessel injury or perforation, distal embolization, residual thrombus, hemolysis and contrast-related complications.
• MRI safety depends on the exact Indigo components and whether they remain in the patient; confirm the current device-specific MRI labeling before scanning.
• The system is not appropriate for every clot or patient. Vessel size, clot organization, severe vessel tortuosity, inability to obtain safe access, bleeding risk and relevant contraindications in the current instructions for use must be assessed.