Indigo Aspiration System - Lightning Flash

FDA-Cleared Indications

• Removal of thrombus from the peripheral vasculature using aspiration thrombectomy.
• Treatment of thromboembolism and thrombosis in vessels that can be reached with the compatible Indigo catheter system.
• Use in adults and pediatric patients when the selected catheter size and system components are appropriate for the patient and vessel.

Clinical Applications

• Aspiration thrombectomy for selected lower-extremity deep vein thrombosis.
• Aspiration thrombectomy for selected pulmonary embolism cases.
• Thrombectomy of selected thrombosed dialysis grafts or fistulas.
• Removal of thrombus from other labeled peripheral vascular locations using the appropriate Indigo catheter and aspiration system.

Reported off-label uses

• Aspiration thrombectomy in selected arterial thrombotic or embolic occlusions when the use is outside the specific cleared indication for the chosen device configuration.
• Treatment of unusual or anatomically complex venous thrombi not specifically described in the device labeling.

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 compatible components; selection depends on vessel diameter, clot burden, access route, and the specific product configuration.
• The procedure is performed under fluoroscopic imaging through vascular access, commonly from the femoral or jugular vein and, for selected arterial procedures, an arterial access site.
• The system is intended for use by trained clinicians familiar with endovascular thrombectomy, aspiration pumps, and management of bleeding, embolization, and vascular injury.
• MRI safety depends on the specific catheter, tubing, and other components. The device should not be assumed to be MRI safe or MRI conditional unless the applicable labeling confirms it; retained or implanted components require separate evaluation.
• Contraindications and warnings include unsuitable vessel anatomy, inability to safely obtain vascular access, active bleeding or severe bleeding risk, and risks related to anticoagulation, contrast, sedation, vascular injury, distal embolization, and incomplete clot removal.