Indigo Aspiration System Lightning Aspiration Tubing

FDA-Cleared Indications

• Used with compatible mechanical thrombectomy systems for the percutaneous removal of thromboemboli and thrombus from peripheral blood vessels.
• Intended for use in the peripheral vasculature when aspiration thrombectomy is clinically appropriate.

Clinical Applications

• Catheter-based aspiration thrombectomy for acute deep vein thrombosis in the lower or upper extremities.
• Mechanical thrombectomy for thrombus in peripheral arteries or veins, when performed within the system's labeled vessel and catheter compatibility requirements.
• Thrombectomy of dialysis access grafts or fistulas when the treated access and device configuration meet the applicable labeling requirements.

Reported off-label uses

• Aspiration thrombectomy for pulmonary embolism has been reported in clinical practice with compatible Indigo system configurations, but use depends on the specific device labeling and is not established by the peripheral mechanical thrombectomy indication alone.
• Removal of thrombus from unusual or pediatric vascular anatomy has been described in reports, but these applications may be outside the cleared indication and require case-specific specialist judgment.

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 tubing is a system component rather than an independent thrombectomy catheter; it must be used with compatible Indigo aspiration equipment and the instructions for use.
• Available tubing and catheter configurations differ in internal diameter, length, aspiration performance and compatibility. The treating clinician should confirm the intended catheter, pump or aspiration source, and connection components before use.
• Access is typically obtained percutaneously through a vascular sheath, with fluoroscopic guidance and local anesthesia with or without moderate sedation; general anesthesia may be used for selected cases.
• Do not use when the device, packaging or tubing is damaged, contaminated or beyond its labeled use. Contraindications and warnings include situations in which vascular access, aspiration thrombectomy or anticoagulation is unsafe.
• The tubing should be treated as a single-use sterile component unless the current labeling specifically states otherwise. MRI safety depends on the complete system and any retained or implanted components; the tubing itself is not an implanted device.