Ekosonic Endovascular Device with Control Unit 4 0

FDA-Cleared Indications

• Used to facilitate the controlled and selective infusion of physician-specified thrombolytic agents into the vasculature.
• Intended for treatment of thrombus in the peripheral vasculature and pulmonary arteries when catheter-directed thrombolysis is appropriate.
• The device is used with compatible thrombolytic drugs and standard endovascular techniques under fluoroscopic or other appropriate imaging guidance.

Clinical Applications

• Catheter-directed thrombolysis for selected patients with acute or subacute deep vein thrombosis.
• Ultrasound-assisted thrombolysis for selected pulmonary embolism patients.
• Treatment of thrombotic occlusion in selected peripheral venous vessels.
• Image-guided infusion of thrombolytic medication through an endovascular catheter.

Reported off-label uses

• Ultrasound-assisted thrombolysis for selected arterial thrombotic occlusions.
• Treatment of selected thrombosed dialysis grafts or fistulas when clinicians determine that off-label use is appropriate.

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 EKOS catheter, control unit, infusion pump, thrombolytic medication, and standard endovascular access equipment; catheter size and working length depend on the selected model and treatment vessel.
• Treatment generally requires venous or arterial access, fluoroscopic imaging, anticoagulation or thrombolytic monitoring, and management in a setting able to monitor bleeding and cardiopulmonary status.
• The device is not intended to replace surgical thrombectomy, aspiration thrombectomy, anticoagulation, or systemic thrombolysis in every patient; treatment selection depends on clot location, severity, bleeding risk, and clinical stability.
• MRI compatibility is model- and configuration-specific. The exact catheter and control-unit labeling should be checked before MRI, and the device should not be assumed to be MRI safe based only on the product name.
• Important risks include bleeding from thrombolytic therapy, vascular injury, hematoma, distal embolization, infection, contrast reaction, and procedure-related cardiopulmonary complications.