đź“Š Evidence-Based Reference
ekosonic endovascular system
Btg International
Summary: The EkoSonic Endovascular System is a catheter-based device used primarily for the treatment of pulmonary embolism. Key evidence highlights its efficacy in improving symptoms and reducing pulmonary hypertension in COVID-19-related cases.
FDA Clearance Information
Pathway 510K
Number K182324 ↗
Decision Date November 26, 2018
Product Code QEY
Device Class Class 2
Evidence 35 studies
The EkoSonic Endovascular System was cleared by the FDA through the 510(k) pathway on November 26, 2018. It is manufactured by Btg International and classified as a Class 2 device.
What It Is
The EkoSonic Endovascular System is a catheter-directed thrombolysis device designed to treat venous thromboembolism, particularly pulmonary embolism. It combines ultrasound technology with thrombolytic drugs to enhance clot dissolution.
Clinical Applications
This device is commonly used in clinical settings for patients with pulmonary embolism, especially those with contraindications to systemic thrombolysis. It is also utilized in cases of COVID-19-related thrombosis.
Evidence Summary
The literature includes 15 studies, comprising case reports and analyses, focusing on the device's use in pulmonary embolism treatment. The studies range from 2020 to 2022.
Reported Outcomes
Published studies report significant improvement in symptoms and normalization of right ventricular size post-treatment with the EkoSonic Endovascular System. In COVID-19 cases, the device has shown efficacy in reducing pulmonary hypertension.
Safety Profile
Reported complications include no significant adverse events in the studies reviewed. One study noted the absence of left ventricular thrombus during echocardiogram post-treatment.
Evidence Limitations
The evidence is limited by the small sample sizes and the predominance of case reports. Further large-scale, randomized controlled trials are needed to establish comprehensive safety and efficacy profiles.
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 System?
The device is indicated for the treatment of venous thromboembolism, particularly pulmonary embolism, and is used in patients with contraindications to systemic thrombolysis.
What outcomes have been reported in clinical studies?
Studies have reported improvements in symptoms and normalization of right ventricular size, with efficacy in reducing pulmonary hypertension in COVID-19-related cases.
What complications have been reported?
Safety data from the evidence indicates no significant adverse events, with one study noting the absence of left ventricular thrombus post-treatment.
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.