Indigo System Aspiration Catheter 7 Indigo Aspiration System Separator 7 Lightning 7

FDA-Cleared Indications

• Removal of thrombi or emboli from the peripheral vascular system.
• Use in vessels with a reference diameter of at least 3 mm, when selected with compatible Indigo System components according to the device labeling.
• Treatment of peripheral arterial and venous thromboembolic disease and occluded dialysis fistulae and grafts.

Clinical Applications

• Catheter-based thrombectomy for selected deep vein thrombosis.
• Mechanical thrombectomy for selected pulmonary embolism when the clot is within the labeled peripheral vascular indication and compatible system components are used.
• Removal of thrombus from selected peripheral arteries or veins.
• Thrombectomy of selected occluded hemodialysis fistulae and grafts.

Reported off-label uses

• Use in selected pulmonary embolism cases outside the specific labeled anatomy or patient population may be described in clinical practice and published reports; this is not an encouragement to use the device outside its labeling.
• Treatment of thrombus in vascular locations or vessel sizes not covered by the device labeling has been reported for some aspiration-catheter systems but should be considered off-label.

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 catheter is used with compatible aspiration tubing, separator components and an aspiration pump or generator, depending on the Indigo System configuration.
• The catheter is advanced over a guidewire under fluoroscopic imaging through an appropriate vascular access site; access and catheter selection depend on the target vessel.
• It is intended for vessels with a reference diameter of at least 3 mm. The treating clinician must confirm catheter, guidewire, sheath and connector compatibility before use.
• Potential concerns include blood loss, vessel injury or perforation, distal embolization, incomplete clot removal, contrast-related complications and complications from vascular access.
• MRI safety depends on the exact catheter and system components and their labeling. The device should not be taken into the MRI environment unless the applicable product labeling confirms that configuration is MR safe or MR conditional.