Ekos Micro-Infusion System

FDA-Cleared Indications

• Used to assist the infusion of thrombolytic medication into thrombus within the vascular system.
• Indicated for treatment of thrombotic occlusions in vessels that can be reached with the catheter using standard percutaneous vascular access techniques.

Clinical Applications

• Catheter-directed treatment of selected deep vein thrombosis.
• Catheter-directed treatment of selected pulmonary embolism.
• Ultrasound-assisted delivery of thrombolytic medication into venous thrombus.
• Treatment of venous thrombosis when restoring blood flow is clinically necessary and catheter-directed thrombolysis is selected.

Reported off-label uses

• Use in selected thrombosed dialysis grafts or fistulas may be reported in clinical practice, but the specific indication should be confirmed against the device's current labeling and institutional protocols.
• Use in arterial thrombosis has been described for some ultrasound-assisted thrombolysis catheter systems, but should not be assumed to be covered by this device's FDA-cleared labeling.

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 placed through percutaneous vascular access, commonly through the femoral or another appropriate venous access site, and positioned across the thrombus under fluoroscopic guidance.
• Catheter size, treatment length, infusion ports, and compatibility with guidewires, sheaths, and thrombolytic medications must be confirmed in the current manufacturer instructions for use.
• Treatment requires careful assessment of bleeding risk, including recent surgery, active bleeding, intracranial disease, uncontrolled hypertension, and other contraindications to thrombolytic medication.
• The system is used with an ultrasound control unit and is not automatically MRI safe; MRI status depends on the complete system configuration and current labeling.
• Patients generally require hospital monitoring for bleeding, changes in clot burden, kidney function when contrast is used, and clinical response to therapy.