Indigo Aspiration System

FDA-Cleared Indications

• Removal of thrombus from peripheral arteries and veins using mechanical aspiration thrombectomy.
• Treatment of peripheral vascular occlusions when clot removal is clinically indicated.

Clinical Applications

• Aspiration thrombectomy for selected peripheral arterial thrombi.
• Aspiration thrombectomy for selected peripheral venous thrombi.
• Mechanical thrombectomy for acute limb ischemia caused by peripheral arterial occlusion.
• Thrombectomy for selected deep vein thrombosis or other peripheral venous occlusions.
• Thrombectomy of selected thrombosed dialysis grafts or fistulas.

Reported off-label uses

• Aspiration thrombectomy for pulmonary embolism with compatible Indigo system configurations; use depends on the specific device labeling and clinical situation.
• Aspiration thrombectomy for cerebral venous sinus thrombosis in selected cases; this is not necessarily covered by the peripheral vascular indication and should not be inferred from the FDA clearance alone.

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 sizes and configurations; selection depends on vessel diameter, clot burden, anatomy, and the compatible aspiration pump or tubing set.
• The procedure is performed through vascular access, commonly from the femoral or other suitable arterial or venous access site, with fluoroscopic imaging and contrast when appropriate.
• Device compatibility, maximum guidewire size, sheath requirements, and aspiration setup must be confirmed in the current instructions for use before the procedure.
• Contraindications and precautions include inability to safely access the target vessel, unsuitable vessel size or anatomy, bleeding risk, and conditions in which anticoagulation or thrombolysis is contraindicated.
• MRI safety depends on the specific Indigo components and whether they remain in the patient; the current device labeling should be checked before MRI. The system is generally removed after thrombectomy and is not intended as a permanent implant.