Indigo Aspiration System Cat RX and Separator 4 - Penumbra Engine Pump and Canister

FDA-Cleared Indications

• Removal of thrombus from peripheral vessels using aspiration thrombectomy.
• Mechanical thrombectomy with aspiration for treatment of peripheral vascular thromboembolism.
• Use with compatible catheters, aspiration tubing, the Penumbra Engine pump and canister as part of the Indigo system.

Clinical Applications

• Aspiration thrombectomy for selected peripheral venous thrombus, including lower-extremity deep vein thrombosis.
• Removal of thrombus from selected peripheral arterial vessels.
• Thrombectomy of selected dialysis grafts or fistulas when the compatible system and catheter are indicated.
• Treatment of peripheral vascular thromboembolism in procedures performed under fluoroscopic imaging.

Reported off-label uses

• Aspiration thrombectomy during selected coronary interventions, including cases with substantial thrombus burden; coronary use depends on the specific device labeling and clinical judgment.
• Aspiration treatment of selected pulmonary emboli; pulmonary embolism use depends on the specific system components, labeling and institutional protocol.

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 CAT RX catheter and Separator 4 must be used with compatible Indigo system components, including the Penumbra Engine pump, aspiration tubing and canister.
• The procedure is performed through percutaneous vascular access under fluoroscopic imaging, with local anesthesia and, when needed, moderate sedation or general anesthesia.
• Device diameter, length and working compatibility must be matched to the target vessel, access route and thrombus burden; available configurations should be confirmed in current manufacturer labeling.
• The system is not a permanent implant. MRI considerations generally relate to any retained wires, filters, stents or other implanted material rather than the removed catheter system; consult current labeling before MRI.
• Potential complications include bleeding or hematoma at the access site, vessel injury, dissection, perforation, distal embolization, hemolysis, infection and incomplete clot removal. Contraindications and warnings in the current instructions for use should be reviewed before treatment.