Ekosonic Endovascular Device

FDA-Cleared Indications

• Infusion of physician-specified thrombolytic medication into thrombus in the peripheral vasculature.
• Use with ultrasound energy to facilitate thrombolytic treatment of blood clots in the peripheral vasculature.
• The specific drug, dose, treatment duration, anatomy, and patient selection must follow the device labeling and the thrombolytic medication's approved labeling.

Clinical Applications

• Catheter-directed thrombolytic treatment of selected lower-extremity deep vein thrombosis.
• Catheter-directed treatment of selected pulmonary embolism using thrombolytic medication.
• Ultrasound-assisted thrombolysis in peripheral venous thrombosis.
• Treatment of selected thrombotic occlusions when a physician determines that catheter-directed thrombolysis is appropriate.

Reported off-label uses

• Treatment of selected thrombosed dialysis grafts or fistulas.
• Treatment of selected acute arterial thrombosis or acute limb ischemia.
• Treatment of thrombus in other peripheral vascular beds when used outside 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 includes an infusion catheter, ultrasound core, and related accessories; catheter lengths and treatment-zone configurations vary by model.
• It is used through a vascular sheath over guidewire access, with imaging guidance such as fluoroscopy and venography or angiography.
• The system requires compatibility with the prescribed thrombolytic medication, infusion pump, sheath, guidewire, and other procedural equipment.
• Treatment requires monitoring for bleeding, including access-site bleeding and potentially serious internal bleeding. Contraindications and precautions include conditions that increase bleeding risk or otherwise preclude thrombolytic therapy.
• MRI safety depends on the specific device components and whether they remain in the patient. The exact model's current instructions for use should be checked before MRI; the system should not be assumed to be MRI safe.