Ekosonic Endovascular System with Control Unit 4 0

FDA-Cleared Indications

• The system is indicated for the treatment of pulmonary embolism and deep vein thrombosis using ultrasound-facilitated catheter-directed thrombolysis.
• It is intended to deliver thrombolytic agents directly into thrombus through an endovascular catheter.
• Use is limited to patients who meet the labeling requirements for the system, including appropriate anatomy, access, and eligibility for thrombolytic therapy.

Clinical Applications

• Catheter-directed treatment of selected pulmonary embolism cases.
• Catheter-directed treatment of lower-extremity deep vein thrombosis.
• Treatment of selected iliofemoral or other large-vessel venous thrombus when thrombolytic therapy is appropriate.
• Ultrasound-assisted infusion of a prescribed thrombolytic medication directly into venous thrombus.

Reported off-label uses

• Treatment of selected upper-extremity or axillosubclavian venous thrombosis.
• Treatment of thrombosed dialysis access circuits or grafts in selected cases.
• Treatment of selected arterial thrombus or acute limb ischemia, depending on device configuration, anatomy, and local practice.

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 core wires, a control unit, and a prescribed thrombolytic agent; catheter length and treatment-zone options must match the anatomy.
• Placement is performed through endovascular access, commonly through the femoral or jugular vein, under fluoroscopic imaging. Treatment requires monitoring for bleeding and other thrombolytic complications.
• Contraindications and precautions include conditions that make thrombolytic therapy unsafe, active bleeding, recent major surgery or trauma, uncontrolled hypertension, and significant bleeding risk; the current manufacturer instructions and thrombolytic labeling should be reviewed.
• MRI safety depends on the specific catheter, ultrasound core wire, and control-unit configuration. The device should not be taken into the MRI environment unless the exact components are labeled MR Safe or MR Conditional and the stated conditions are followed.
• The device is intended for temporary treatment and is removed after the prescribed infusion or thrombus-treatment session; it is not a permanent implant.