đź“Š Evidence-Based Reference
ekos pe endovascular device with control system 4 0 cs4 0
Ekos
Summary: The Ekos PE Endovascular Device is used for mechanical thrombectomy in venous applications, particularly for pulmonary embolism. Key evidence highlights its efficacy in improving clinical status with minimal bleed risk.
FDA Clearance Information
Pathway 510K
Number K200648 ↗
Decision Date August 17, 2020
Product Code QEY
Device Class Class 2
Evidence 35 studies
The Ekos PE Endovascular Device was cleared by the FDA via the 510(k) pathway on August 17, 2020. It is manufactured by Ekos and classified as a Class 2 device under product code QEY.
What It Is
The Ekos PE Endovascular Device is a catheter-based system designed for ultrasound-assisted thrombolysis. It is intended for use in the treatment of pulmonary embolism by enhancing clot dissolution with reduced thrombolytic agent dosage.
Clinical Applications
This device is commonly used in clinical scenarios involving acute pulmonary embolism, especially in patients at high risk of bleeding where traditional systemic thrombolysis poses significant risks.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, case series, and systematic reviews, conducted between 2022 and 2025. These studies evaluate the safety and efficacy of the device in clinical settings.
Reported Outcomes
Published studies report that the Ekos PE Endovascular Device improves clinical status in patients with massive pulmonary embolism, with significant recovery of right ventricular function. The device has shown efficacy in reducing the risk of death or cardiovascular collapse in high-risk patients.
Safety Profile
Reported complications include minimal bleed risk associated with the use of ultrasound-assisted, catheter-directed thrombolysis. The device is considered safe for patients with extreme bleeding risk.
Evidence Limitations
Current evidence is limited by the small sample sizes in some studies and the need for longer-term follow-up to assess sustained outcomes. Further research is needed to establish standardized protocols and evaluate long-term 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 Ekos PE Endovascular Device?
The device is indicated for use in mechanical thrombectomy for venous thromboembolism, particularly in the management of pulmonary embolism.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved clinical status and recovery of right ventricular function in patients with pulmonary embolism.
What complications have been reported?
Safety data indicates minimal bleed risk, making it suitable for patients with high bleeding risk.
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.