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ekosonic endovascular device with control unit 4 0
Btg International
Summary: The Ekosonic Endovascular Device by Btg International is used for mechanical thrombectomy in venous applications. Key evidence shows its efficacy in resolving ischemia and restoring normal blood flow.
FDA Clearance Information
Pathway
510K
Number
K183361 ↗
Decision Date
April 5, 2019
Product Code
QEY
Device Class
Class 2
Evidence
35 studies
The Ekosonic Endovascular Device was cleared by the FDA through the 510(k) pathway on April 5, 2019. It is manufactured by Btg International and classified as a Class 2 device under product code QEY.
What It Is
The Ekosonic Endovascular Device is a mechanical thrombectomy tool designed for venous applications. It utilizes ultrasound technology to enhance thrombolysis, aiding in the dissolution of blood clots and restoration of blood flow.
Clinical Applications
This device is commonly used in clinical scenarios involving acute limb ischemia and pulmonary embolism. It provides a minimally invasive option for patients requiring rapid clot resolution.
Evidence Summary
The available literature includes four studies, comprising case series and other study types, conducted between 2013 and 2022. These studies explore the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report successful resolution of ischemia and restoration of normal blood flow in patients treated with the Ekosonic Endovascular Device. In one case series, symptoms of ischemia were resolved, and angiographic control showed normal flow in the axillary artery.
Safety Profile
Reported complications include local deficits, although one study noted that the patient was discharged without any local deficits of the right hand. Overall, the device has demonstrated a favorable safety profile in the studies reviewed.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design, including case series and other non-randomized formats. Further research is needed to establish long-term outcomes and broader applicability.
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 mechanical thrombectomy in venous applications, particularly in cases of acute limb ischemia and pulmonary embolism.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful resolution of ischemia and restoration of normal blood flow in treated patients.
What complications have been reported?
Safety data from evidence indicate that complications are minimal, with one study reporting no local deficits upon patient discharge.
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.