Ekos Micro-Infusion System

FDA-Cleared Indications

• Treatment of venous thrombosis using catheter-directed infusion of thrombolytic medication with ultrasound assistance.
• Use in selected patients when targeted clot treatment is clinically indicated and appropriate thrombolytic therapy is prescribed.

Clinical Applications

• Catheter-directed thrombolytic treatment of selected lower-extremity deep vein thrombosis.
• Catheter-directed thrombolytic treatment of selected pulmonary embolism involving the pulmonary arteries.
• Ultrasound-assisted delivery of thrombolytic medication directly within a venous blood clot.
• Treatment of acute venous thrombosis in a hospital or interventional procedure setting when rapid clot reduction is needed.

Reported off-label uses

• Use in selected thrombosed dialysis grafts or fistulas has been described for catheter-directed thrombolytic treatment, but the specific device labeling and local regulatory requirements should be reviewed before use.
• Use in other peripheral venous or arterial thrombotic conditions may be reported in clinical practice, but is not necessarily covered by the FDA-cleared indication.

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 uses a catheter with an ultrasound element and infusion ports; the available catheter size and treatment length must match the target vessel and clot.
• It is used with an appropriate thrombolytic medication selected and dosed by the treating clinician; drug compatibility and preparation instructions must be followed.
• Placement is performed under imaging guidance, commonly fluoroscopy, through venous access such as the femoral or internal jugular vein.
• Important risks include bleeding, access-site complications, clot migration or embolization, infection, contrast reaction, vessel injury and complications from thrombolytic medication.
• MRI safety depends on the specific catheter and system components. The exact model should be checked in the current manufacturer instructions before MRI; an indwelling treatment catheter is generally not assumed to be MRI safe without verification.