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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 typically used by interventional radiologists and vascular surgeons to treat patients with thrombotic conditions.
FDA Clearance Information
Pathway 510K
Number K053432 ↗
Decision Date December 30, 2005
Product Code QEY
Device Class Class 2
Evidence 35 studies
The Ekos Micro-Infusion System was cleared through the FDA 510(k) pathway on December 30, 2005. 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 designed to enhance the delivery of thrombolytic drugs directly into the thrombus, using ultrasound technology to facilitate clot dissolution. This system combines mechanical and pharmacological methods to improve the efficiency of clot removal. It is particularly useful in cases where rapid restoration of blood flow is critical.
Clinical Applications
This device is commonly used in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). It is employed in hospital settings, particularly in interventional radiology suites or catheterization labs. The primary users are interventional radiologists, vascular surgeons, and cardiologists who specialize in the management of thrombotic disorders.
Indications for Use
The Ekos Micro-Infusion System is indicated for patients with venous thrombotic conditions, such as DVT and PE. It is used to break down clots and restore blood flow in affected veins, reducing the risk of complications associated with these conditions.
Practical Considerations
The system typically involves catheters that are compatible with standard vascular access techniques. Clinicians should be familiar with ultrasound guidance and the pharmacokinetics of thrombolytic agents when using this device. Proper sizing and positioning are crucial for optimal results.
Related Literature
The Interventional Management of Stroke (IMS) III Trial investigated the efficacy of endovascular therapy in acute ischemic stroke. Although specific details are not available, such trials generally assess outcomes like recanalization rates and functional recovery. Limitations may include sample size and variability in intervention techniques.
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 thrombotic conditions, such as deep vein thrombosis and pulmonary embolism.
What specialties typically use this device?
Interventional radiologists, vascular surgeons, and cardiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for mechanical thrombectomy in venous systems, particularly for conditions like DVT and PE.
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.