Ekosonic Endovascular System

FDA-Cleared Indications

• Infusion of physician-specified thrombolytic drugs into the peripheral pulmonary arteries for treatment of pulmonary embolism.
• Infusion of physician-specified thrombolytic drugs into the peripheral vasculature for treatment of thrombus.
• Use of ultrasound energy to facilitate catheter-directed thrombolytic treatment in the labeled vascular territories.

Clinical Applications

• Catheter-directed thrombolytic treatment of pulmonary embolism involving the peripheral pulmonary arteries.
• Ultrasound-assisted delivery of thrombolytic medication to clot in the peripheral pulmonary vasculature.
• Catheter-directed thrombolytic treatment of thrombus in peripheral blood vessels.
• Treatment of selected venous thromboembolic disease when a clinician determines that local thrombolytic therapy is appropriate.

Reported off-label uses

• Ultrasound-assisted catheter-directed thrombolysis for selected deep vein thrombosis involving the iliac, femoral, or other large peripheral veins.
• Ultrasound-assisted thrombolysis for selected thrombosed dialysis grafts or fistulas.
• Use in other thrombotic vascular beds or clinical situations outside the device's cleared labeling, based on institutional practice and available clinical evidence.

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 compatible infusion catheters, ultrasound components, guidewires, infusion tubing, and a physician-selected thrombolytic drug; exact catheter configuration and lengths vary by model.
• Access is commonly obtained through the common femoral or internal jugular vein, with treatment performed under fluoroscopic imaging; local anesthesia with moderate sedation or another anesthesia plan may be used.
• Thrombolytic therapy can cause serious bleeding, including intracranial bleeding. Active bleeding, recent major surgery, recent intracranial hemorrhage, uncontrolled hypertension, and other contraindications to thrombolytics require careful evaluation.
• MRI compatibility depends on the specific catheter, generator, and accessories and on whether the system is being used or remains in the patient. The product labeling and institutional MRI policy must be checked before MRI.
• Treatment duration, infusion dose, monitoring, and need for repeat imaging depend on clot burden, anatomy, bleeding risk, and the thrombolytic protocol; the device does not replace anticoagulation or surgical and aspiration thrombectomy options when those are more appropriate.