đź“Š Evidence-Based Reference
ekosonic endovascular system with rapid pulse modulation
Ekos
Summary: The Ekosonic Endovascular System is a device used for ultrasound-assisted thrombolysis in treating pulmonary embolism. Key evidence supports its use in rapidly resolving thrombus and restoring cardiopulmonary function.
FDA Clearance Information
Pathway 510K
Number K081467 ↗
Decision Date June 26, 2008
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 June 26, 2008. It is manufactured by Ekos and classified as a Class 2 device.
What It Is
The Ekosonic Endovascular System is a medical device designed for ultrasound-assisted thrombolysis. It is used in the clinical setting to treat thrombotic conditions, particularly pulmonary embolism, by enhancing the delivery and efficacy of thrombolytic agents.
Clinical Applications
This device is commonly used in cases of submassive and massive pulmonary embolism where rapid thrombus resolution is critical. It provides a catheter-directed approach to thrombolysis, offering an alternative to systemic anticoagulation.
Evidence Summary
The available literature includes two studies, one published in 2011 and another in 2014. These studies encompass various methodologies, including prospective and retrospective analyses, focusing on the safety and effectiveness of ultrasound-accelerated thrombolysis.
Reported Outcomes
Published studies report that the Ekosonic Endovascular System is effective in reducing thrombus burden and improving cardiopulmonary function in patients with pulmonary embolism. The studies highlight its potential to rapidly resolve thrombus compared to traditional treatments.
Safety Profile
Reported complications include those typical of catheter-directed thrombolysis procedures, although specific adverse events are not detailed in the provided evidence. Further research is needed to comprehensively assess the safety profile.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety outcomes. Further research is necessary to establish standardized treatment algorithms and to evaluate long-term efficacy and safety.
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 submassive and massive pulmonary embolism using ultrasound-assisted thrombolysis.
What outcomes have been reported in clinical studies?
Studies report effective thrombus reduction and improved cardiopulmonary function in patients with pulmonary embolism.
What complications have been reported?
Reported complications include those typical of catheter-directed thrombolysis, though specific adverse events are not detailed in the provided studies.
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.