📊 Evidence-Based Reference

ekos ultrasound infusion system

Ekos

Summary: The Ekos Ultrasound Infusion System is a device used for ultrasound-assisted thrombolysis in patients with thrombotic conditions. It is primarily used in cases where systemic thrombolysis is contraindicated. Key evidence highlights its efficacy in improving hemodynamics in pulmonary embolism patients.

FDA Clearance Information

Pathway 510K
Decision Date April 27, 2005
Product Code NUI
Device Class Class 2
Evidence 35 studies

The Ekos Ultrasound Infusion System was cleared by the FDA via the 510(k) pathway on April 27, 2005. Manufactured by Ekos, it is classified as a Class 2 device under product code NUI.

What It Is

The Ekos Ultrasound Infusion System is a catheter-based device that uses ultrasound to enhance the delivery of thrombolytic agents directly to thrombi. It is intended for use in the treatment of thrombotic conditions, particularly when systemic thrombolysis is not an option.

Clinical Applications

Commonly used in the management of acute pulmonary embolism and deep vein thrombosis, the device is particularly beneficial in patients who cannot undergo systemic thrombolysis. It is employed in scenarios requiring targeted thrombolysis to improve patient outcomes.

Evidence Summary

The available literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, conducted between 2021 and 2023. These studies evaluate the device's efficacy and safety in various thrombotic conditions.

Reported Outcomes

Published studies report that the Ekos Ultrasound Infusion System effectively reduces pulmonary artery pressures and improves cardiac index in patients with pulmonary embolism. One study noted a significant reduction in systolic and mean pulmonary artery pressures post-treatment. The device has shown promise in reversing right ventricular dysfunction.

Safety Profile

Reported complications include minor bleeding at the access site, with no intracranial hemorrhages observed. The studies indicate a favorable safety profile, with no deaths or therapy intensifications reported within 180 days post-treatment.

Evidence Limitations

Current evidence is limited by small sample sizes and the need for further research to establish optimal dosing regimens. Long-term outcomes and comparisons with alternative therapies require additional investigation.

Linked Studies (20)

PubMed • 2026

Real-world clinical outcomes of EKOS catheter-directed thrombolysis versus systemic alteplase in acute pulmonary embolism: a retrospective cohort study.

Frontiers in pharmacology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Novel Phase Shift Microbubbles, MVT-101, Enhance Sonothrombolysis in a Porcine Model of Deep Vein Thrombosis.

Nanotheranostics

View Source →
PubMed • 2024

[Interventional therapy of pulmonary embolism - update].

Deutsche medizinische Wochenschrift (1946)

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

Initiating and imaging cavitation from infused echo contrast agents through the EkoSonic catheter.

Scientific reports

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

[Ultrasound-accelerated thrombolysis. Initial experience in patients with contraindications to systemic thrombolysis].

Revista medica del Instituto Mexicano del Seguro Social

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

Quantifying the Effect of Acoustic Parameters on Temporal and Spatial Cavitation Activity: Gauging Cavitation Dose.

Ultrasound in medicine & biology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Treatment With EkoSonic™ Endovascular System (EKOS®) of Massive Pulmonary Thrombosis Following Recovery From COVID-19 Infection.

Cureus

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

EkoSonic™ Endovascular System-Directed Thrombolysis in a Patient With COVID-19 Infection Presenting With Bilateral Large Pulmonary Embolism Causing Right Ventricular Strain: A Case Report.

Cureus

Case Report View Source →
PubMed • 2022

Analysis of pulmonary embolism patients treated with EkoSonic™ endovascular system.

Turk gogus kalp damar cerrahisi dergisi

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Successful Thrombolysis of Acute Upper Limb Ischemia Using Ekosonic Endovascular System Ultrasound Catheter in a Patient With Atrial Fibrillation.

Cardiovascular revascularization medicine : including molecular interventions

Case Series View Source →
PubMed • 2022

Stability of alteplase for ultrasound-facilitated catheter-directed thrombolysis.

Blood advances

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Massive pulmonary embolism in patients with extreme bleeding risk: a case series on the successful use of ultrasound-assisted, catheter directed thrombolysis in a district general hospital.

Journal of thrombosis and thrombolysis

Case Series View Source →
PubMed • 2022

EKOS™ Jena Experience: Safety, Feasibility, and Midterm Outcomes of Percutaneous Ultrasound-Assisted Catheter-Directed Thrombolysis in Patients with Intermediate-High-Risk or High-Risk Pulmonary Embolism.

Canadian respiratory journal

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2021

Cavitation Emissions Nucleated by Definity Infused through an EkoSonic Catheter in a Flow Phantom.

Ultrasound in medicine & biology

View Source →
PubMed • 2021

Hemodynamic Effects of Ultrasound-Assisted, Catheter-Directed, Very Low-Dose, Short-Time Duration Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism (from the EKOS-PL Study).

The American journal of cardiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020

Ekosonic Endovascular System (EKOS) in a trauma patient with intracranial bleed, recent major surgery, and massive pulmonary embolus: A case report.

Radiology case reports

Case Report View Source →
PubMed • 2020

EkoSonic Thrombolysis as a Therapeutic Adjunct in Venous Occlusive Disease.

The International journal of angiology : official publication of the International College of Angiology, Inc

Retrospective|case Series View Source →
PubMed • 2020

The Role of EkoSonic Endovascular System or EKOS® in Pulmonary Embolism.

Cureus

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020

EkoSonic® endovascular system and other catheter-directed treatment reperfusion strategies for acute pulmonary embolism: overview of efficacy and safety outcomes.

Expert review of medical devices

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020

Real-World Outcomes of EKOS Ultrasound-Enhanced Catheter-Directed Thrombolysis for Acute Limb Ischemia.

Annals of vascular surgery

RCT|prospective|retrospective|case Series|other View Source →

Frequently Asked Questions

What are the clinical indications for Ekos Ultrasound Infusion System?

The device is indicated for ultrasound-assisted thrombolysis in patients with thrombotic conditions, particularly when systemic thrombolysis is contraindicated.

What outcomes have been reported in clinical studies?

Studies have reported significant improvements in pulmonary hemodynamics and cardiac function in patients with pulmonary embolism.

What complications have been reported?

Safety data indicate minor bleeding complications, with no major adverse events such as intracranial hemorrhages reported.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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