Indigo R Aspiration System Lightning Flash Aspiration Tubing Indigo R Aspiration System Lightning Bolt Aspiration Tubing

FDA-Cleared Indications

• Mechanical thrombectomy with aspiration for removing thrombus from the peripheral vasculature.
• Use in the peripheral venous system when catheter-based aspiration thrombectomy is clinically appropriate.

Clinical Applications

• Aspiration thrombectomy for selected lower-extremity deep vein thrombosis.
• Aspiration thrombectomy for selected pulmonary embolism involving the pulmonary arteries.
• Aspiration thrombectomy for selected thrombosed dialysis grafts or fistulas when the treated anatomy and device configuration are compatible with the labeling.

Reported off-label uses

• Aspiration thrombectomy in other peripheral venous segments not specifically covered by the device labeling may be reported in clinical practice, but this is off-label and should be evaluated by the treating specialist.

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 aspiration tubing configurations, including Lightning Flash and Lightning Bolt, and the treating physician selects components based on vessel anatomy, clot burden and procedural access.
• The system is used with catheterization techniques under fluoroscopic or other appropriate imaging guidance, generally through venous access such as the femoral or jugular vein.
• Device sizing, aspiration settings and compatibility with the intended catheter and ancillary equipment must be confirmed in the current manufacturer instructions for use.
• MRI safety depends on the specific implanted or retained components; the device is used during a procedure rather than left permanently in the body. MRI conditions should be verified in the current labeling before scanning.
• Contraindications, warnings and bleeding risks must be reviewed in the current FDA-cleared labeling. Mechanical thrombectomy may not be appropriate for every patient, and medication or surgical treatment may also be considered.