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Ekos Ultrasound Evd Device Evd Control Unit
Btg International
Summary: The EKOS Ultrasound EVD Device by BTG International is a Class 2 medical device used for mechanical thrombectomy in venous systems. It is primarily utilized by interventional radiologists and vascular surgeons to treat patients with venous thromboembolism.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K172035 ↗
Decision Date ?
March 24, 2018
Product Code ?
JXG
Device Class ?
Class 2
Evidence ?
35 studies
The EKOS Ultrasound EVD Device was cleared via the FDA 510(k) pathway on March 24, 2018. Manufactured by BTG International, it is classified as a Class 2 device under product code JXG.
What It Is
The EKOS Ultrasound EVD Device is designed to enhance the removal of thrombi in the venous system through mechanical thrombectomy. It uses ultrasound technology to facilitate the breakdown of blood clots, allowing for more effective thrombolysis. This device is part of a control unit system that provides clinicians with precise control during the procedure.
FDA-Cleared Indications
- Used with compatible EKOS catheter systems for the controlled delivery of ultrasound energy during catheter-directed thrombolytic treatment.
- Intended to assist the treatment of thromboembolic disease in the peripheral vasculature and pulmonary arteries when used according to the compatible catheter system's labeling.
- The control unit is not a standalone thrombectomy device; its indication depends on the specific compatible EKOS catheter and treatment system.
Clinical Applications
- Catheter-directed treatment of selected deep vein thrombosis using an ultrasound-assisted thrombolysis system.
- Catheter-directed treatment of selected pulmonary embolism using compatible EKOS therapy components.
- Ultrasound-assisted thrombolytic treatment of thromboembolic disease in appropriately selected peripheral venous vessels.
- Use by interventional specialists in a hospital or procedure-suite setting with fluoroscopic or other appropriate imaging guidance.
Practical Considerations
- The control unit must be used with compatible EKOS catheters, connectors and other system components; it is not intended to be used independently.
- Treatment typically requires venous access, guidewire and catheter placement under fluoroscopic or other appropriate imaging guidance, followed by infusion of a prescribed thrombolytic medication when indicated.
- Patient selection should account for bleeding risk, recent surgery or trauma, intracranial hemorrhage risk and other contraindications to thrombolytic therapy.
- MRI safety depends on the specific control unit, catheter and accessories. The system should be removed from the MRI environment unless the current manufacturer labeling specifically identifies the components as MR safe or MR conditional.
- The device requires trained personnel, equipment checks and monitoring for bleeding, hemodynamic changes, catheter complications and other procedure-related risks.
Procedures that use this device
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 Ultrasound EVD Device used for?
It is used for the mechanical removal of blood clots in the venous system, particularly in cases of deep vein thrombosis and pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the treatment of venous thromboembolism through mechanical thrombectomy, particularly when anticoagulation therapy is inadequate.
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.