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ekosonic endovascular device
Btg International
Summary: The EkoSonic endovascular device is used for ultrasound-assisted thrombolysis in venous thrombectomy. Key evidence highlights its role in improving outcomes in acute limb ischemia and pulmonary embolism.
FDA Clearance Information
Pathway 510K
Number K191119 ↗
Decision Date August 23, 2019
Product Code QEY
Device Class Class 2
Evidence 35 studies
The EkoSonic endovascular device was cleared through the FDA 510(k) pathway on August 23, 2019. It is manufactured by Btg International and classified as a Class 2 device.
What It Is
The EkoSonic endovascular device facilitates ultrasound-assisted thrombolysis, enhancing the breakdown of thrombi in venous thrombectomy. It is intended for use in conditions like acute limb ischemia and pulmonary embolism.
Clinical Applications
Commonly used in scenarios such as acute limb ischemia and pulmonary embolism, the EkoSonic device aids in thrombus dissolution, potentially improving patient outcomes and reducing the need for more invasive procedures.
Evidence Summary
The literature includes 15 studies, ranging from randomized controlled trials to retrospective analyses, conducted between 2021 and 2025. These studies explore the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report improved limb salvage and amputation-free survival rates in acute limb ischemia. In pulmonary embolism cases, the device has been associated with expedited right ventricular recovery, particularly when used alongside extracorporeal membrane oxygenation.
Safety Profile
Reported complications include potential myocardial gas embolization and bleeding risks associated with thrombolysis. However, the use of low-dose alteplase in conjunction with the device has been shown to mitigate some bleeding risks.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term outcome data. Further research is needed to establish the device's efficacy across diverse patient populations and to explore its long-term safety profile.
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 EkoSonic endovascular device?
The EkoSonic device is indicated for use in ultrasound-assisted thrombolysis for conditions such as acute limb ischemia and pulmonary embolism.
What outcomes have been reported in clinical studies?
Studies have reported improved limb salvage and amputation-free survival in acute limb ischemia, as well as expedited right ventricular recovery in pulmonary embolism.
What complications have been reported?
Reported complications include myocardial gas embolization and bleeding risks, though low-dose alteplase use may reduce bleeding complications.
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.