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Ekosonic Endovascular Device
Summary: The Ekosonic Endovascular Device is used for ultrasound-assisted thrombolysis in vascular conditions. It is primarily used in cases of acute pulmonary embolism and limb ischemia. Key evidence highlights its efficacy in resolving ischemia and restoring normal blood flow.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K211080 ↗
Decision Date ?
November 19, 2021
Product Code ?
QEY Mechanical Thrombolysis Catheter
Device Class ?
Class 2
Evidence ?
35 studies
The Ekosonic Endovascular Device was cleared by the FDA through the 510(k) pathway on November 19, 2021. It is manufactured by Boston Scientific and classified as a Class 2 device.
What It Is
The Ekosonic Endovascular Device is a catheter-based system designed for ultrasound-assisted thrombolysis. It is intended for the controlled infusion of thrombolytics into the peripheral vasculature and pulmonary arteries, aiding in the dissolution of thrombi.
FDA-Cleared Indications
- Controlled infusion of thrombolytic medication into the peripheral vasculature to help dissolve thrombi.
- Controlled infusion of thrombolytic medication into the pulmonary arteries to help dissolve thrombi.
Clinical Applications
- Catheter-directed thrombolysis for selected acute pulmonary embolism cases.
- Catheter-directed thrombolysis for thrombotic occlusion in peripheral arteries or veins.
- Ultrasound-assisted treatment of selected acute limb ischemia caused by thrombus.
- Local thrombolytic infusion during treatment of selected peripheral vascular thrombosis.
Reported off-label uses
- Treatment of selected deep vein thrombosis with ultrasound-assisted catheter-directed thrombolysis when the use does not match the device labeling or local regulatory authorization.
- Treatment of selected thrombosed dialysis grafts or fistulas using ultrasound-assisted thrombolytic infusion.
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 series and other study types, published between 2020 and 2022. These studies explore the device's efficacy and safety in various clinical scenarios, focusing on thrombolysis outcomes.
Reported Outcomes
Published studies report that the Ekosonic Endovascular Device effectively resolves ischemia and restores normal blood flow in affected arteries. In cases of acute limb ischemia, symptoms were resolved, and angiographic control showed normal flow. The device has also been used successfully in pulmonary embolism cases, contributing to right ventricular recovery.
Safety Profile
Reported complications include local deficits, although patients were discharged without any long-term deficits. The safety profile is generally favorable, with no significant adverse events reported in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and to compare the device's efficacy with other thrombolytic strategies.
Practical Considerations
- The system is used with an appropriate thrombolytic medication; medication choice, dose and infusion duration are determined by the treating team.
- Access is commonly obtained through a peripheral vein or artery, depending on the clot location. Fluoroscopy and contrast angiography are typically used for positioning and treatment assessment.
- The catheter must be compatible with the selected vascular access sheath, guidewire and thrombolytic infusion setup; exact catheter lengths, treatment zones and other dimensions depend on the specific model.
- Bleeding risk, including intracranial or access-site bleeding, is an important consideration because treatment involves thrombolytic medication. Recent surgery, active bleeding, bleeding disorders and other contraindications to thrombolysis must be assessed.
- MRI safety and conditions depend on the specific device configuration and model. The device should be removed before MRI unless the applicable manufacturer labeling specifically identifies it as MR conditional under stated conditions.
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 Device?
The device is indicated for ultrasound-assisted thrombolysis in cases of acute pulmonary embolism and acute limb ischemia.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful resolution of ischemia and restoration of normal blood flow in affected arteries.
What complications have been reported?
Reported complications include local deficits, but patients were generally discharged without long-term issues.
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.