Indigo System Aspiration Catheter 12 Indigo Aspiration System Separator 12

FDA-Cleared Indications

• Percutaneous removal of thrombus from the peripheral vascular system.
• Use with compatible Indigo aspiration systems for mechanical thrombectomy procedures.
• Intended for thrombus removal in vessels appropriate for the catheter's size and design.

Clinical Applications

• Peripheral venous thrombectomy for selected patients with acute venous thrombus.
• Catheter-based treatment of deep vein thrombosis when mechanical thrombus removal is indicated.
• Removal of thrombus from dialysis grafts or fistulas as part of dialysis-access thrombectomy.
• Catheter-directed thrombus removal in other labeled peripheral vascular applications selected by the treating physician.

Reported off-label uses

• Aspiration thrombectomy for pulmonary embolism has been described in clinical practice and literature for some Indigo system configurations, but the specific cleared indication and catheter configuration must be verified before use.
• Aspiration treatment of thrombus in vascular territories or clinical situations outside the device labeling has been reported, but such use is off-label and should be based on appropriate clinical judgment and institutional protocols.

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 and Separator 12 must be used with compatible Indigo system components and an appropriate aspiration source according to the instructions for use.
• The catheter size limits the vessels and access routes that can be treated; operators should confirm sheath, guide catheter, wire, and vessel compatibility before the procedure.
• Treatment is performed under fluoroscopic imaging, usually through percutaneous vascular access. Sedation or anesthesia depends on the access site, thrombus location, and patient condition.
• Contraindications and warnings include inability to safely obtain vascular access, unsuitable vessel anatomy, severe vascular injury risk, and conditions in which thrombectomy or anticoagulation is unsafe.
• MRI safety and conditional-use information should be checked in the current manufacturer labeling. Do not assume the assembled catheter, Separator, tubing, and other components have identical MRI status.