EKOS and EKOS+ Endovascular System Brief Summary

INTENDED USE

The EKOS+ Endovascular Device is intended to be used with EKOS-branded control systems to employ high frequency (1.5 MHz to 1.9 MHz), low-power ultrasound to facilitate the infusion of physician-specified fluids, including procedural fluids and thrombolytics, into the pulmonary and/or peripheral vasculature of adults. It is intended to be used by physicians experienced in endovascular interventional procedures. The EKOS+ Endovascular System is not intended for use in the neurovasculature.

Refer to the product insert supplied with the physician-specified fluid for fluid-specific preparation, contraindications, side effects, warnings, and precautions.

INDICATIONS FOR USE

The EKOS+ Endovascular System, consisting of the Infusion Catheter and the Ultrasonic Core, is indicated for the:

• Ultrasound facilitated, controlled and selective intravascular infusion of physician-specified fluids, including thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis.
• Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries and/or peripheral vasculature.

Clinical Benefit Statement

The EKOS+ Endovascular Device is intended for the controlled and selective infusion of
physician-specified fluids, including thrombolytics, into the peripheral vasculature or the pulmonary arteries. The clinical benefit can be measured by overall clinical outcomes, including, but not limited to, improved right ventricular heart function and hemodynamic stability when treating PE or the ability to infuse physician-specified fluids into the peripheral vasculature, along with low rates of hemorrhage, recurrent PE, and all-cause mortality.

CONTRAINDICATIONS

The EKOS+ Endovascular Device is contraindicated for use in:

• Patients in whom thrombolytic and/or anticoagulation therapy is contraindicated.
• Any situation in which the medical judgment of the physician determines such a procedure may compromise the patient’s condition.

WARNINGS

The following warning statements provide important information for safe operation of the EKOS+ Endovascular System. Observe all warnings provided in these Instructions for Use. Failure to do so may result in patient injury, operator injury, or product damage.

• Always verify that BOTH electrical connectors from an Ultrasonic Core and Infusion Catheter pair are connected to the SAME Connector Interface Cable (CIC). Failure to properly connect both electrical connectors from an Ultrasonic Core-Infusion Catheter pair to the same CIC could result in over-temperature operation of the Ultrasonic Core, potentially causing damage to the patient’s vasculature. 
• Never aspirate blood back into the drug lumens as perfusion pores and/or drug lumens may become occluded. 
• Do not connect the Infusion Catheter “Drug” or “Coolant” infusion luers to a power injector. 
• Do not exceed 200 psi applied to any infusion luer. 
• If flow through the Infusion Catheter becomes restricted, do not attempt to clear by high pressure infusion. Either remove the Infusion Catheter (and Ultrasonic Core, if in place) to determine and eliminate the cause of the obstruction or replace the Infusion Catheter with a new Infusion Catheter of the same model. 
• Never activate ultrasound energy with the Infusion Catheter or Ultrasonic Core’s working length exposed to the air. The device should be placed within the patient anatomy, with physician-specified fluids running through the drug lumen and coolant flowing through the coolant lumen. Otherwise, overheating may occur, potentially causing burns, damage to the Ultrasonic Core, and/or interrupting therapy. 
• Always turn off the ultrasound before removing the Ultrasonic Core from the Infusion Catheter. Otherwise, overheating may occur, potentially causing burns, damage to the Ultrasonic Core, and/or interrupting therapy. Use of a damaged Ultrasonic Core may result in vascular trauma. 
• Do not deform or kink the Ultrasonic Core during delivery into the Infusion Catheter. If the Ultrasonic Core is kinked at any time, do not attempt to use the Ultrasonic Core, as kinking may lead to degraded performance or fracture during use. 
• Never attempt to use the Ultrasonic Core with any catheter except the compatible EKOS+ Infusion Catheter. 
• Do not attempt to use non-compatible working lengths (i.e., 135 cm Infusion Catheter and 106 cm Ultrasonic Core and vice-versa). Incorrect size matching may be harmful to the patient and require additional intervention or surgery. 
• Never place the Ultrasonic Core into the patient without previously placing the Infusion Catheter. 
• Never immerse the electrical connectors or the gray housing of the Infusion Catheter in fluid. 
• Do not use an introducer sheath with a rotating hemostasis valve to introduce the EKOS+ Endovascular Device. Insertion or removal through a rotating hemostasis valve may result in removal of the radiographic marker band, stretching, or other damage to the catheter. 
• The EKOS+ Endovascular System is not intended for use in the neurovasculature.

PRECAUTIONS

Carefully read all Instructions for Use prior to use. Observe all precautions noted throughout these instructions. Failure to do so may result in complications.

• Prior to introduction, and each time the Infusion Catheter is removed from the vascular system, the Infusion Catheter should be flushed. 
• If flow through the Infusion Catheter becomes restricted, do not attempt to clear by high pressure infusion. Either remove the Infusion Catheter (and Ultrasonic Core, if in place) to determine and eliminate the cause of the obstruction or replace the Infusion Catheter with a new Infusion Catheter of the same model. 
• The EKOS+ device is designed to provide optimum acoustic output during the first 24 hours of operation. 
• The EKOS+ device should only be used to infuse physician-specified fluids, including thrombolytics. Other types of fluids, outside of thrombolytics and procedural fluids (heparinized saline, saline, contrast media, etc.), have not been evaluated for use with the EKOS Endovascular Device. 
• This device is not designed for use as a peripheral vascular dilator. • During normal use, ultrasound energy may cause a temperature rise in the treatment zone. The catheter surface temperature is limited to a maximum of 43 °C. 
• Therapeutic agents, such as thrombolytics, should be administered through the drug port whereas the procedural fluids (such as saline and contrast agent) should be administered through the coolant port or central lumen. 
• EKOS+ Endovascular Devices will only run on EKOS Control Unit 4.0. They are not compatible with earlier generations of EKOS / EkoSonic Control Units. If EKOS+ device is connected to a control unit other than EKOS CU 4.0, the EKOS+ device will not be recognized by the control unit and will require exchange of device or control unit in order to proceed.

ADVERSE EVENTS

Potential adverse events which may be associated with use of the EKOS+ Endovascular System when used as indicated include, but are not limited to:

• Allergic reaction (contrast, device, or other) 
• Arrhythmia 
• Burn 
• Cardiac Tamponade
• Cardiac Trauma 
• Death
• Embolism (air, device, plaque, thrombus, tissue, or other) 
• Hematoma 
• Hemorrhage 
• Hypotension
• Infection/Sepsis 
• Ischemia/Necrosis 
• Need for additional intervention or surgery 
• Pain
• Pneumothorax 
• Renal Insufficiency/Failure
• Respiratory Failure 
• Thrombosis/Thrombus 
• Vasospasm
• Vessel Occlusion 
• Vessel Trauma (AV fistula, dissection, perforation, pseudoaneurysm, rupture or injury)

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