Ekosonic Endovascular System with Rapid Pulse Modulation

FDA-Cleared Indications

• Ultrasound-assisted catheter-directed thrombolysis of thrombus in the pulmonary arteries.
• Mechanical thrombolysis of peripheral vascular thrombus when used with the compatible catheter configuration and thrombolytic medication.
• Use in adults when catheter-directed infusion of a thrombolytic agent is clinically indicated and consistent with the specific cleared device labeling.

Clinical Applications

• Catheter-directed thrombolysis for pulmonary embolism.
• Ultrasound-assisted infusion of thrombolytic medication into pulmonary arterial thrombus.
• Catheter-directed treatment of selected peripheral venous thrombus, including deep vein thrombosis, when the applicable catheter and drug labeling are followed.
• Treatment of selected thrombosed dialysis grafts or fistulas when the device configuration and thrombolytic agent are compatible with the cleared indication.

Reported off-label uses

• Catheter-directed thrombolysis for selected arterial thrombosis or acute limb ischemia.
• Ultrasound-assisted thrombolysis for other venous thromboembolic locations not specifically covered by the applicable 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 generally requires percutaneous venous access for pulmonary embolism treatment; access may be obtained through the common femoral or internal jugular vein depending on anatomy and operator preference.
• Treatment requires a compatible infusion catheter, ultrasound core, control unit, and a labeled thrombolytic medication. Catheter length, diameter, infusion-zone length, and guidewire compatibility vary by model.
• The device is used with fluoroscopic imaging and usually requires anticoagulation management, laboratory monitoring, and observation for bleeding or recurrent embolism.
• Contraindications and precautions include active or recent major bleeding, conditions that substantially increase bleeding risk, allergy to the thrombolytic agent, and inability to obtain safe vascular access; the thrombolytic drug labeling also applies.
• MRI safety depends on the specific catheter and system components. The device should not be taken into the MRI environment unless the exact model is confirmed as MR Conditional and all stated conditions are followed.