Ekos Micro-Infusion System

FDA-Cleared Indications

• Infusion of thrombolytic medication into a blood clot in the peripheral vasculature.
• Ultrasound-assisted delivery of thrombolytic therapy for treatment of venous thromboembolism, including deep vein thrombosis and pulmonary embolism.
• Use by trained clinicians with compatible thrombolytic drugs and standard endovascular catheter techniques.

Clinical Applications

• Catheter-directed thrombolytic treatment of selected lower-extremity deep vein thrombosis.
• Ultrasound-assisted thrombolytic treatment of selected pulmonary embolism.
• Targeted infusion of thrombolytic medication into an acute venous clot when systemic medication alone is not appropriate or sufficient.
• Endovascular clot-treatment procedures performed in an interventional radiology, vascular, or catheterization laboratory.

Reported off-label uses

• Ultrasound-assisted thrombolytic treatment of thrombosed dialysis grafts or fistulas.
• Use in selected thrombosed venous stents or other peripheral venous segments outside the device's specific labeled 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 system is used with a compatible infusion catheter, ultrasound core, and prescribed thrombolytic medication; catheter size and treatment length must match the target vessel and clot.
• Treatment requires fluoroscopic or other image guidance, anticoagulation and thrombolytic-management protocols, and monitoring for bleeding and recurrent thrombosis.
• The system is not a substitute for anticoagulation, surgical thrombectomy, or other mechanical thrombectomy methods; treatment selection depends on clot location, symptoms, bleeding risk, and clinical urgency.
• MRI safety depends on the specific catheter and system components. The device should be removed or managed according to the current manufacturer labeling before MRI.
• Important contraindications and precautions include active bleeding, recent major surgery or intracranial bleeding, uncontrolled hypertension, allergy to the thrombolytic medication, and other standard contraindications to thrombolysis.