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ekos micro-infusion system
Ekos
Summary: The Ekos Micro-Infusion System is a medical device used for mechanical thrombectomy in venous systems. It is primarily used by interventional radiologists and vascular specialists to treat patients with blood clots.
FDA Clearance Information
Pathway 510K
Number K063620 ↗
Decision Date August 6, 2007
Product Code QEY
Device Class Class 2
Evidence 35 studies
The Ekos Micro-Infusion System was cleared via the FDA 510k pathway on August 6, 2007. It is manufactured by Ekos and classified as a Class 2 device under product code QEY.
What It Is
The Ekos Micro-Infusion System is a catheter-based device designed to deliver thrombolytic agents directly into blood clots. It utilizes ultrasound technology to enhance the penetration and effectiveness of these agents, facilitating faster and more complete clot dissolution. This system is particularly useful in treating deep vein thrombosis (DVT) and pulmonary embolism (PE).
Clinical Applications
Clinically, the Ekos Micro-Infusion System is used in hospital settings, particularly in interventional radiology and vascular surgery departments. It is employed in the treatment of patients with acute venous thromboembolism, including those with DVT and PE. The system is beneficial for patients who require rapid clot resolution to prevent complications such as post-thrombotic syndrome or recurrent embolism.
Indications for Use
The FDA indications for the Ekos Micro-Infusion System involve the treatment of venous thrombosis. This includes conditions like deep vein thrombosis and pulmonary embolism, where the device aids in breaking down blood clots to restore normal blood flow.
Practical Considerations
The Ekos Micro-Infusion System comes in various catheter sizes to accommodate different vessel diameters and clot locations. It is compatible with standard thrombolytic agents and requires careful monitoring of infusion rates and ultrasound settings to optimize treatment outcomes.
Related Literature
The Interventional Management of Stroke (IMS) III Trial investigated the efficacy of endovascular therapy in acute ischemic stroke. Although specific details about the Ekos Micro-Infusion System's role in this study are not available, the trial generally highlighted the potential benefits of mechanical thrombectomy in improving patient outcomes. Limitations included variability in treatment protocols and patient selection criteria.
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 is the Ekos Micro-Infusion System used for?
It is used for the treatment of venous thrombosis, including deep vein thrombosis and pulmonary embolism, by delivering thrombolytic agents directly into blood clots.
What specialties typically use this device?
Interventional radiologists and vascular specialists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the treatment of venous thrombosis, specifically for breaking down blood clots in conditions like deep vein thrombosis and pulmonary embolism.
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.