Indigo R Aspiration System - Lightning R Flash

FDA-Cleared Indications

• Percutaneous removal of thrombus from vessels in the peripheral vasculature.
• Use in patients with thrombotic or embolic occlusion of peripheral vessels when mechanical thrombectomy is clinically appropriate.
• The system is a Class II device cleared through the FDA 510(k) pathway under product code QEW.

Clinical Applications

• Catheter-based thrombectomy for selected lower-extremity deep vein thrombosis.
• Aspiration thrombectomy for selected pulmonary embolism procedures when the treated anatomy and device labeling are appropriate.
• Removal of thrombus from dialysis grafts or fistulas during dialysis-access thrombectomy.
• Percutaneous aspiration thrombectomy in other labeled peripheral-vessel applications selected by the treating physician.

Reported off-label uses

• Aspiration thrombectomy in peripheral arterial occlusion outside the device's specific cleared indication or labeled vessel conditions.
• Treatment of selected unusual venous or arterial thrombotic locations not specifically covered by 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 treating team must confirm catheter size, aspiration tubing, guidewire, sheath, and introducer compatibility before the procedure.
• Access is commonly obtained through a percutaneous venous or arterial puncture, depending on the clot location; fluoroscopy and contrast venography or angiography are typically used.
• The system is intended for single-use procedures and should be handled according to the current instructions for use, including aspiration-system priming and blood-loss precautions.
• MRI safety depends on the specific components left in or removed from the patient; the team should review the current manufacturer labeling before MRI, particularly if any component remains indwelling.
• Potential concerns include bleeding at the access site, vessel injury, blood loss, distal embolization, contrast reaction, kidney injury from contrast, and incomplete clot removal. Anticoagulation, catheter-directed thrombolysis, open surgery, or observation may be more appropriate in some patients.