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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 utilized by interventional radiologists and vascular specialists to treat patients with blood clots.

FDA Clearance Information

Pathway 510K
Decision Date June 10, 2005
Product Code NUI
Device Class Class 2
Evidence 35 studies

The Ekos Micro-Infusion System was cleared through the FDA 510(k) pathway on June 10, 2005. Manufactured by Ekos, it is classified as a Class 2 medical device under product code NUI.

What It Is

The Ekos Micro-Infusion System is a catheter-based device designed to deliver thrombolytic drugs directly to blood clots while simultaneously using ultrasound energy to enhance drug penetration and clot dissolution. This dual-action approach allows for more efficient and targeted clot removal, reducing the risk of complications associated with systemic thrombolysis.

Clinical Applications

This device is commonly used in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). It is particularly beneficial in acute settings where rapid clot resolution is critical. Interventional radiologists and vascular surgeons often employ this system in hospital settings, especially in patients who are at high risk for complications from untreated clots.

Indications for Use

The FDA-cleared indications for the Ekos Micro-Infusion System include the treatment of venous thrombosis, particularly in cases where rapid clot resolution is necessary. It is suitable for patients with conditions like DVT and PE.

Practical Considerations

The device is available in various catheter sizes to accommodate different vessel diameters and is compatible with standard thrombolytic agents. Clinicians should be trained in catheter placement and ultrasound operation to maximize efficacy and minimize risks.

Related Literature

The Interventional Management of Stroke (IMS) III Trial investigated the efficacy of endovascular therapy in stroke management. Although specific details of the study are not available, it likely explored the use of devices like the Ekos Micro-Infusion System in improving outcomes for stroke patients. Limitations may include the lack of detailed results and the study's focus on arterial rather than venous applications.

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, specifically deep vein thrombosis and pulmonary embolism.

What specialties typically use this device?

Interventional radiologists and vascular surgeons typically use this device.

What are the FDA-cleared indications?

The device is indicated for the treatment of venous thrombosis, including 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.

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