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 ?
510(k)
Number ?
K182324 ↗
Decision Date ?
November 26, 2018
Product Code ?
QEY Mechanical Thrombolysis Catheter
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.
FDA-Cleared Indications
- Catheter-directed thrombolysis of blood clots in the peripheral vasculature.
- Treatment of pulmonary embolism using ultrasound-assisted delivery of thrombolytic medication.
- Treatment of deep vein thrombosis and other venous thromboembolic disease when catheter-directed thrombolysis is clinically appropriate.
Clinical Applications
- Ultrasound-assisted catheter-directed thrombolysis for pulmonary embolism.
- Catheter-directed thrombolysis for lower-extremity deep vein thrombosis.
- Treatment of selected peripheral venous thromboembolism when local thrombolytic therapy is indicated.
- Use with an appropriate thrombolytic drug delivered through the infusion catheter under image guidance.
Reported off-label uses
- Use in selected COVID-19-associated pulmonary thrombosis or pulmonary embolism cases has been described in clinical reports, but this is not a separate FDA indication.
- Use for thrombus in dialysis access circuits has been reported for ultrasound-assisted thrombolysis, but device selection and labeling must be confirmed for the specific system and anatomy.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The system requires vascular access, fluoroscopic or other appropriate imaging guidance, and administration of a compatible thrombolytic medication.
- Available catheter and wire configurations have specific diameter, length, infusion-zone, and vessel-size requirements; operators should follow the current instructions for use.
- Bleeding risk, including access-site bleeding and major bleeding from thrombolytic therapy, must be assessed. Active bleeding, recent major surgery, intracranial hemorrhage, and other thrombolytic contraindications may preclude treatment.
- MRI safety depends on the specific catheter, wire, and generator configuration. Do not assume the system is MRI safe; review the current manufacturer labeling before MRI.
- The device is intended for temporary procedural use and is removed after treatment; it is not a permanent implant.
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 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.