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ekosonic endovascular system
Ekos
Summary: The EkoSonic Endovascular System is a catheter-based device used for mechanical thrombectomy in venous thromboembolism cases. Key evidence indicates its efficacy in treating pulmonary embolism, particularly in patients with COVID-19.
FDA Clearance Information
Pathway 510K
Number K111705 ↗
Decision Date August 3, 2011
Product Code QEY
Device Class Class 2
Evidence 35 studies
The EkoSonic Endovascular System was cleared by the FDA via the 510(k) pathway on August 3, 2011. It is manufactured by Ekos 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 by delivering ultrasound-assisted, low-dose thrombolytic therapy directly to the site of the clot. It is intended for use in patients with pulmonary embolism and other thrombotic conditions.
Clinical Applications
Common clinical scenarios for the EkoSonic Endovascular System include treatment of massive and submassive pulmonary embolism, especially in patients with contraindications to systemic thrombolysis, such as those with recent surgery or intracranial bleeding.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, case reports, and retrospective analyses, published between 2020 and 2022. These studies evaluate the device's efficacy and safety in treating pulmonary embolism.
Reported Outcomes
Published studies report significant improvement in symptoms and normalization of right ventricular size in patients treated with the EkoSonic Endovascular System. Case reports highlight its effectiveness in resolving pulmonary embolism in COVID-19 patients.
Safety Profile
Reported complications include no significant adverse events related to the device, with one study noting the absence of left ventricular thrombus during echocardiogram. Overall, the device is considered safe for use in indicated scenarios.
Evidence Limitations
The evidence is limited by the small sample sizes and the predominance of case reports and retrospective studies. Further large-scale, randomized controlled trials are needed to confirm the long-term efficacy and safety of the 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, in patients who may not be candidates for systemic thrombolysis.
What outcomes have been reported in clinical studies?
Clinical studies have reported significant symptom improvement and normalization of right ventricular size post-treatment with the EkoSonic Endovascular System.
What complications have been reported?
Safety data from evidence indicate no significant device-related complications, with studies noting the absence of left ventricular thrombus in treated patients.
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.