Ekosonic Endovascular Device Ekos Endovascular Device

FDA-Cleared Indications

• Used with thrombolytic agents to facilitate the infusion and delivery of physician-specified thrombolytic drugs into the pulmonary arteries or peripheral vasculature.
• Intended for treatment of pulmonary embolism and peripheral vascular thrombotic occlusions when catheter-directed thrombolytic therapy is clinically appropriate.
• The device is a Class II mechanical thrombolysis catheter cleared under FDA 510(k) K213422.

Clinical Applications

• Catheter-directed thrombolysis for selected lower-extremity deep vein thrombosis.
• Catheter-directed treatment of selected pulmonary embolism involving the pulmonary arteries.
• Ultrasound-assisted thrombolytic infusion for peripheral vascular thrombotic occlusions.
• Treatment of selected acute venous or peripheral arterial thrombotic disease when a clinician determines that local thrombolytic therapy is appropriate.

Reported off-label uses

• Use in selected thrombosed dialysis grafts or fistulas has been described in clinical practice, but applicability depends on the specific device configuration, thrombolytic agent, anatomy, and current labeling.
• Use in other peripheral venous or arterial thrombotic beds outside the cleared indication may be reported, but should be considered off-label and evaluated by the treating specialist.

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 vascular access, fluoroscopic positioning, an infusion pump or compatible thrombolytic delivery setup, and connection to the ultrasound control system.
• Available catheter lengths, treatment zones, and diameters vary by model; selection must match the target vessel, access route, and the manufacturer's compatibility requirements.
• It is used with a physician-selected thrombolytic medication, so bleeding risk, recent surgery or trauma, intracranial bleeding history, anticoagulation status, and other thrombolytic contraindications must be reviewed.
• MRI compatibility is model-specific. Confirm the exact device labeling before MRI; an indwelling or recently placed catheter and its connected components should not be assumed to be safe in the scanner.
• The device is intended for temporary endovascular treatment and is removed after the planned thrombolytic infusion or intervention; it is not a permanent implant.