đź“Š Evidence-Based Reference
ekosonic endovascular system with control unit 4 0
Btg International
Summary: The EkoSonic Endovascular System is a device combining ultrasound with catheter-directed thrombolysis, primarily used for thrombus removal in venous thrombosis. Key evidence highlights its efficacy in reducing clot burden with minimized bleeding risks.
FDA Clearance Information
Pathway 510K
Number K162771 ↗
Decision Date February 24, 2017
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 February 24, 2017. Manufactured by Btg International, it is classified as a Class 2 device under product code QEY.
What It Is
The EkoSonic Endovascular System is a medical device that uses ultrasound technology combined with catheter-directed thrombolysis to target and dissolve thrombi. It is intended for use in patients with venous thrombosis, offering a minimally invasive approach to clot removal.
Clinical Applications
Commonly used in the treatment of pulmonary embolism and upper limb ischemia, the EkoSonic Endovascular System is employed in scenarios where precise thrombus removal is required. It is particularly beneficial for patients at intermediate to high risk of bleeding from systemic thrombolysis.
Evidence Summary
The available literature includes 8 studies, comprising randomized controlled trials, retrospective analyses, and case series, published between 2017 and 2026. These studies evaluate the efficacy and safety of the EkoSonic system in various thrombotic conditions.
Reported Outcomes
Published studies report that the EkoSonic Endovascular System effectively resolves symptoms of ischemia and restores normal blood flow in affected vessels. In cases of pulmonary embolism, it has shown promising outcomes in clot dissolution with reduced systemic exposure to thrombolytics.
Safety Profile
Reported complications include local deficits, which were resolved without long-term effects. The device's focused delivery minimizes systemic bleeding risks, making it a safer alternative for certain patient populations.
Evidence Limitations
Current evidence is limited by the small sample sizes and retrospective nature of some studies. Further research is needed to establish long-term outcomes and to compare its efficacy directly with other thrombectomy methods.
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 EkoSonic Endovascular System is indicated for use in patients with venous thrombosis, including pulmonary embolism and upper limb ischemia.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective thrombus resolution and restored blood flow, with reduced systemic bleeding risks.
What complications have been reported?
Safety data indicate minimal complications, with some reports of local deficits that resolved without long-term effects.
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.