EkoSonic™ Endovascular System
The EkoSonic Endovascular System for the ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism (PE), deep vein thrombosis (DVT) and peripheral arterial occlusion (PAO).
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Product Description
EKOS therapy is a minimally invasive system for dissolving thrombus. The ultrasonic core generates an acoustic field which greatly accelerates lytic dispersion by driving the drug deeper into the clot and unwinding the fibrin to expose plasminogen receptor sites.
- Speeds time-to-clot dissolution.1
- Lowers the risk of bleeding and other complications2·3
- Reduces dosage requirements by as much as 68% compared to standard CDT3
- Schrijver, A.M., et al., “Dutch Randomized Trial Comparing Standard Catheter-Directed Thrombolysis Versus Ultrasound-Accelerated Thrombolysis for Arterial Thromboembolic Infrainguinal Disease (DUET)” Journal of Endovascular Therapy 2015; 22(1):87-95.
- Lin, P., et al., “Comparison of Percutaneous Ultrasound-Accelerated Thrombolysis versus Catheter-Directed Thrombolysis in Patients with Acute Massive Pulmonary Embolism.” Vascular, Vol. 17, Suppl. 3, 2009, S137–S147.
- Parikh, S., et al., “Ultrasound-Accelerated Thrombolysis for the Treatment of Deep Vein Thrombosis: Initial Clinical Experience.” Journal of Vascular and Interventional Radiology, Vol. 19, Issue 4, April 2008, 521–528.
Product Specifications and Sizes
The EkoSonic Endovascular System includes an ultrasonic core within an infusion catheter, and control unit.
EKOS is an efficient, three-step process:
- Insert the EKOS 5.4 F infusion catheter through the thrombus.
- Insert the ultrasonic core until it locks in place.
- Activate the lytic infusion and acoustic pulse.
Treatment zones range from 6cm to 50cm with radiopaque marker bands at each end of the treatment zone to enhance visualization. At-a-glance operating status, alarms and treatment times are easy to read from a distance.
Clinical Trial
OPTALYSE
Optimum Duration and Dose of r-tPA with the Acoustic Pulse Thrombolysis Procedure for Submassive Pulmonary Embolism: OPTALYSE PE
Conclusion:The EKOS system’s very-low-dose and short-duration regimens in the OPTALYSE PE trial appear to be as acutely effective as the regimens in other EKOS studies (ULTIMA & SEATTLE II), pointing to a paradigm-changing approach for PE treatment. These results offer physicians a new treatment standard for proven PE clinical efficacy and safety.
ULTIMA
Randomized, Controlled Trial of Ultrasound-Assisted Catheter-Directed Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism
Conclusion:ULTIMA confirmed that a fixed-dose, ultrasound-assisted catheter-directed thrombolysis using EKOS regimen was superior to anticoagulation alone in improving RV dysfunction at 24 hours without an increase in bleeding complications.
SEATTLE II
A Prospective, Single-Arm, Multicentre Trial of UltrasoundFacilitated, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism
Conclusion: Ultrasound-facilitated, catheter-directed, low-dose fibrinolysis for acute PE improves RV function and decreases pulmonary hypertension and angiographic obstruction. By minimizing the risk of intracranial bleed, it represents a potential “game-changer” in the treatment of high-risk PE patients.