Ekos Micro-Infusion System

FDA-Cleared Indications

• Treatment of blood clots in the venous system using catheter-directed thrombolytic therapy.
• Mechanical disruption or infusion-assisted treatment of venous thrombi, consistent with FDA product code QEY for mechanical thrombolysis catheters.

Clinical Applications

• Catheter-directed thrombolysis for selected patients with acute deep vein thrombosis.
• Catheter-directed treatment of selected pulmonary emboli when rapid clot reduction is clinically needed.
• Delivery of thrombolytic medication directly into an obstructing venous clot under imaging guidance.
• Treatment of venous thrombosis in a hospital-based interventional radiology or vascular procedure setting.

Reported off-label uses

• Treatment of selected thrombosed dialysis grafts or fistulas when used as part of a thrombectomy strategy.
• Catheter-directed thrombolysis for selected arterial thrombosis, depending on the specific device labeling, anatomy, and institutional protocol.

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 system is available in catheter configurations intended for different vessel sizes and clot locations; the treating physician selects the appropriate option.
• It is designed to work with compatible thrombolytic medications, which require monitoring for bleeding, medication dose, and infusion duration.
• Treatment is performed with fluoroscopic or other imaging guidance, usually through venous access such as the common femoral or internal jugular vein.
• MRI safety depends on the exact catheter and system components. The device should not be taken into an MRI scanner unless the current manufacturer labeling identifies the specific components as MR Safe or MR Conditional.
• Important risks and limitations include bleeding, vascular injury, contrast reaction, infection, clot embolization, and complications from thrombolytic medication; contraindications are assessed before treatment.