Indigo Aspiration System - Aspiration Catheter 12 and Separator 12

FDA-Cleared Indications

• Aspiration and removal of thrombus from peripheral blood vessels.
• Mechanical thrombectomy using aspiration for treatment of peripheral vascular occlusions.
• The device is classified under product code QEW for peripheral mechanical thrombectomy with aspiration.

Clinical Applications

• Endovascular aspiration thrombectomy for selected lower-extremity deep vein thrombosis.
• Aspiration thrombectomy for selected pulmonary embolism procedures when the device and technique are used within applicable labeling.
• Thrombectomy of an occluded dialysis graft or arteriovenous fistula.
• Removal of thrombotic material from other labeled peripheral vessels under image guidance.

Reported off-label uses

• Cerebral venous sinus thrombosis, when used outside the device's peripheral vascular labeling.
• Other neurovascular thrombectomy applications not specifically covered by the FDA-cleared indication.

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 Aspiration Catheter 12 and Separator 12 are relatively large-bore components; vessel caliber, thrombus burden and access anatomy must be assessed before treatment.
• The system is used with compatible aspiration equipment, tubing and image-guided catheterization techniques. Access is commonly obtained through the femoral or another appropriate venous or arterial access site depending on the target vessel.
• Operators should follow the current manufacturer instructions for use for compatibility, separator manipulation, aspiration settings, flushing and maximum recommended use conditions.
• MRI safety and conditional-use information is device- and component-specific. Confirm the current labeling before MRI; do not assume the catheter, separator or retained components are safe in all MRI environments.
• Potential complications include bleeding at the access site, vascular injury, perforation, embolization, contrast reaction, infection, hemolysis and incomplete clot removal. Patient selection and contraindications should be reviewed against the current FDA-cleared labeling and instructions for use.