Indigo Aspiration System

FDA-Cleared Indications

• Mechanical thrombectomy for removing thrombus from peripheral arteries and veins.
• Aspiration-based removal of blood clots using compatible Indigo catheters and aspiration components.
• Use in patients who require endovascular removal of thrombus to restore or improve blood flow.

Clinical Applications

• Endovascular thrombectomy for selected acute peripheral arterial occlusion.
• Endovascular thrombectomy for selected venous thrombosis.
• Removal of thrombus during DVT mechanical thrombectomy.
• Removal of thrombus from a thrombosed dialysis graft or fistula.
• Treatment of selected peripheral thromboembolic occlusions when catheter-based aspiration is appropriate.

Reported off-label uses

• Aspiration thrombectomy for pulmonary embolism is performed in some clinical settings, but the specific indication depends on the device configuration and applicable labeling; clinicians should verify current FDA labeling before use.
• Aspiration thrombectomy for cerebral venous sinus thrombosis has been described in clinical practice and literature, but this should not be assumed to be an FDA-cleared indication for every Indigo configuration.

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 and lengths vary by Indigo model; the catheter must match the target vessel, clot burden, access route, and aspiration system.
• Use requires compatible vascular access, guidewires or sheaths when specified, and fluoroscopic or other appropriate imaging guidance.
• The device is intended for intravascular use and is not appropriate when vascular access, anticoagulation, or aspiration thrombectomy is contraindicated.
• MRI safety depends on the specific catheter and components; verify the current manufacturer labeling before an MRI examination, particularly while any component remains in the body.
• Potential complications include bleeding, vessel injury or perforation, distal embolization, hemolysis, contrast-related complications, infection, and incomplete clot removal.