Indigo Aspiration System - Aspiration Catheter 7 and Separator 7

FDA-Cleared Indications

• Removal of thrombi and emboli from vessels in the peripheral vasculature.
• Use in the peripheral vasculature, excluding the coronary and cerebral vasculature.
• Intended for patients who require mechanical removal of thromboembolic material using aspiration.

Clinical Applications

• Aspiration thrombectomy for selected peripheral venous thrombi and emboli.
• Mechanical thrombectomy for deep vein thrombosis involving appropriately sized peripheral veins.
• Removal of thrombus from dialysis grafts or fistulas when the treated anatomy and device size are compatible.
• Aspiration-based treatment of selected peripheral vascular occlusions.

Reported off-label uses

• Aspiration thrombectomy for pulmonary embolism has been reported in clinical practice, but use depends on the specific device labeling, anatomy, institutional protocols, and physician judgment.
• Aspiration thrombectomy for cerebral venous sinus thrombosis has been described, but cerebral applications may fall outside the labeling for this peripheral vascular device.

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 a large-lumen Aspiration Catheter 7 and a Separator 7; catheter dimensions, required sheath size, and access strategy must be checked against the current instructions for use.
• The device is introduced through vascular access and used with fluoroscopic imaging. Treatment commonly requires anticoagulation management and may use local anesthesia with moderate sedation or general anesthesia, depending on the procedure.
• It is intended for peripheral vasculature and should not be assumed to be cleared for coronary or cerebral arterial use.
• MRI safety depends on the specific components and whether they remain in the patient; consult the current manufacturer labeling before MRI.
• Potential complications include bleeding at the access site, vessel injury, perforation, distal embolization, infection, contrast reaction, kidney injury, and recurrent thrombosis.