📊 Evidence-Based Reference

ekos peripheral infusion system

Ekos

Summary: The Ekos Peripheral Infusion System is a catheter-based device used for mechanical thrombectomy in venous systems. It is primarily used for conditions like acute limb ischemia and deep vein thrombosis. Key evidence highlights its efficacy in thrombolysis with ultrasound assistance.

FDA Clearance Information

Pathway 510K
Decision Date October 14, 2003
Product Code QEY
Device Class Class 2
Evidence 35 studies

The Ekos Peripheral Infusion System was cleared by the FDA via the 510(k) pathway on October 14, 2003. It is manufactured by Ekos and classified as a Class 2 device under product code QEY.

What It Is

The Ekos Peripheral Infusion System is a catheter-based device designed to deliver thrombolytic agents directly to thrombi in the venous system. It utilizes ultrasound technology to enhance the penetration and efficacy of thrombolytic drugs, facilitating the breakdown of clots.

Clinical Applications

This device is commonly used in the treatment of acute limb ischemia and deep vein thrombosis. It is particularly beneficial in scenarios where rapid thrombolysis is required to restore blood flow and prevent tissue damage.

Evidence Summary

The available literature includes a mix of randomized controlled trials, prospective and retrospective studies, and case series, with a total of 8 studies. The studies span from 2013 to 2025, providing a comprehensive overview of the device's clinical applications.

Reported Outcomes

Published studies report that the Ekos Peripheral Infusion System is effective in enhancing thrombolysis in cases of acute limb ischemia and deep vein thrombosis. The use of ultrasound-assisted thrombolysis has been associated with improved rates of limb salvage and reduced amputation rates. However, outcomes may vary based on patient demographics such as sex.

Safety Profile

Reported complications include bleeding events, which are common with thrombolytic therapies. The studies highlight the importance of careful patient selection and monitoring to minimize adverse events. No new safety concerns were identified in the reviewed studies.

Evidence Limitations

The evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to establish long-term outcomes and to explore the device's efficacy across diverse patient populations.

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 Peripheral Infusion System?

The device is indicated for the treatment of acute limb ischemia and deep vein thrombosis, where enhanced thrombolysis is required.

What outcomes have been reported in clinical studies?

Studies report improved thrombolysis, increased limb salvage rates, and reduced amputation rates, particularly with ultrasound assistance.

What complications have been reported?

Reported complications include bleeding events, which are typical of thrombolytic therapies. Careful monitoring is advised to mitigate risks.

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.

📬 Stay Updated

Get the latest vascular education content delivered to your inbox.