Penumbra Embolectomy Aspiration System Indigotm Aspiration System

FDA-Cleared Indications

• Intended for the removal of thrombus from the peripheral vasculature using aspiration.
• Used with compatible aspiration catheters and accessories selected for the target vessel and clot.
• FDA product code QEW identifies this device category as peripheral mechanical thrombectomy with aspiration.

Clinical Applications

• Aspiration thrombectomy for selected acute deep vein thrombosis.
• Aspiration thrombectomy for selected pulmonary embolism when the specific system configuration and catheter are labeled for that use.
• Thrombectomy of selected peripheral venous thrombi.
• Mechanical thrombectomy for selected thrombosed dialysis grafts or fistulas when the specific device configuration is indicated for that application.

Reported off-label uses

• Aspiration thrombectomy for selected arterial occlusions outside the device's specific cleared labeling.
• Removal of thrombus from unusual or smaller vascular beds when performed outside the labeled indications.

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

• Catheter diameter, working length, and aspiration tubing must be matched to the target vessel, introducer sheath, and aspiration pump or console.
• The procedure is performed under fluoroscopic imaging, usually through venous or arterial access selected for the treatment site. Sedation or general anesthesia depends on the patient's condition and procedure complexity.
• The system is intended for single use; it is not an implant and does not remain in the body after thrombectomy.
• MRI safety depends on the specific components. Catheters, tubing, and accessories should be removed before MRI unless the current manufacturer labeling specifically identifies a component as MR Safe or MR Conditional.
• Potential complications include bleeding at the access site, vessel injury, distal embolization, blood loss, contrast reaction, kidney injury, infection, and incomplete clot removal. Patient selection and contraindications follow the current device labeling and the treating team's assessment.