Ekos Endovascular Device

FDA-Cleared Indications

• Used to facilitate the infusion of thrombolytic agents into blood clots in the peripheral vasculature.
• Used to facilitate the infusion of thrombolytic agents into pulmonary emboli.
• Used with thrombolytic medication to assist clot dissolution in appropriately selected patients.

Clinical Applications

• Catheter-directed, ultrasound-assisted thrombolysis for selected pulmonary embolism.
• Catheter-directed treatment of selected lower-extremity deep vein thrombosis.
• Treatment of venous thromboembolism when targeted thrombolytic infusion is clinically appropriate.
• Use during image-guided endovascular procedures in which a thrombolytic agent is delivered directly into a clot.

Reported off-label uses

• Use in selected thrombosed dialysis grafts or fistulas as part of catheter-directed thrombolysis or thrombectomy strategies.
• Use in other peripheral venous thromboses not specifically covered by the device's 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 system is used with a compatible catheter, guidewire, ultrasound-control equipment and a prescribed thrombolytic medication; the device does not dissolve clot without medication.
• Access is commonly obtained through a peripheral venous site, such as the femoral or popliteal vein, depending on the clot location and treatment plan.
• Available catheter configurations and working lengths vary; the treating team must match catheter size, length and infusion segment to the vessel and clot anatomy.
• Patients require careful assessment for bleeding risk, including recent surgery, active bleeding, intracranial hemorrhage, severe uncontrolled hypertension and other contraindications to thrombolytic therapy.
• MRI compatibility depends on the specific catheter and system configuration. The exact device labeling should be checked before MRI, and the catheter should not be assumed to be safe in the scanner.