Ekos Peripheral Infusion System

FDA-Cleared Indications

• Infusion of thrombolytic agents into thrombi in peripheral vessels.
• Mechanical disruption or treatment of peripheral vascular thrombus using a catheter-based system.
• Use in conjunction with thrombolytic therapy when catheter-directed clot treatment is clinically appropriate.

Clinical Applications

• Catheter-directed thrombolysis for selected deep vein thrombosis.
• Treatment of selected peripheral arterial thrombi, including acute limb ischemia, when consistent with the applicable device labeling and thrombolytic-agent labeling.
• Thrombolytic treatment of thrombosed dialysis grafts or fistulas when the system and accompanying medications are used according to their labeling.
• Peripheral catheter-directed clot treatment performed through venous or arterial access under fluoroscopic guidance.

Reported off-label uses

• Catheter-directed thrombolysis for selected pulmonary embolism cases using an appropriate EKOS pulmonary embolism system or compatible device configuration; this indication depends on the specific device model and labeling.
• Ultrasound-assisted thrombolysis for other peripheral venous or arterial occlusions outside the specific 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 exact catheter diameter, infusion length, guidewire requirements, and compatibility depend on the specific EKOS system and treatment site; clinicians should verify the current instructions for use.
• Treatment generally requires image-guided vascular access, infusion of a thrombolytic medication, and monitoring for bleeding and clot-related complications.
• Contraindications and precautions include active bleeding, recent major surgery or intracranial bleeding, uncontrolled hypertension, bleeding disorders, and other contraindications to the selected thrombolytic agent.
• MRI safety is model- and component-specific. Confirm the current MR labeling before bringing any EKOS catheter, controller, connector, or accessory into the MRI environment.
• The catheter is a temporary treatment device and is removed after the prescribed infusion or intervention; it is not intended for permanent implantation.