Ekos PE Endovascular Device with Control System 4 0 CS4 0

FDA-Cleared Indications

• Used for the infusion of physician-specified thrombolytic agents into the pulmonary arteries or peripheral vasculature.
• Uses ultrasound energy to enhance the penetration and activity of thrombolytic medication within thrombus.
• Intended for treatment of thrombus in the pulmonary arteries and peripheral vasculature.

Clinical Applications

• Catheter-directed thrombolysis for selected acute pulmonary embolism patients.
• Ultrasound-assisted thrombolysis for selected deep vein thrombosis involving the peripheral venous system.
• Catheter-directed treatment of thrombus in peripheral veins when thrombolytic infusion is clinically appropriate.
• Adjunctive treatment of venous thrombus during an endovascular thrombectomy or thrombolysis procedure.

Reported off-label uses

• Ultrasound-assisted thrombolysis for selected thrombosed dialysis grafts or fistulas.
• Use in selected arterial thrombotic conditions, depending on local practice and clinician judgment.

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 requires a compatible vascular access sheath, infusion pump, thrombolytic medication, and the EKOS control unit; catheter and sheath sizes depend on the specific configuration and treatment vessel.
• Placement is performed under fluoroscopic imaging, usually through venous access such as the common femoral or internal jugular vein for pulmonary embolism treatment.
• The device delivers ultrasound energy but does not replace anticoagulation, thrombolytic medication, aspiration, mechanical thrombectomy, surgery, or supportive care when those treatments are indicated.
• Contraindications and precautions include factors that make catheterization, thrombolytic therapy, anticoagulation, or bleeding risk unacceptable; the current device labeling and thrombolytic-drug labeling should be reviewed.
• MRI compatibility depends on the specific catheter and control-system components. The device should not be taken into the MRI environment unless the applicable labeling identifies the component as MR Safe or MR Conditional and specifies the required conditions.