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ekos peripheral infusion system
Ekos
Summary: The Ekos Peripheral Infusion System is a catheter-based device used primarily for mechanical thrombectomy in venous applications. Key evidence highlights its use in acute limb ischemia and deep vein thrombosis with ultrasound-assisted thrombolysis.
FDA Clearance Information
Pathway 510K
Number K030637 ↗
Decision Date July 22, 2003
Product Code QEY
Device Class Class 2
Evidence 35 studies
The Ekos Peripheral Infusion System was cleared by the FDA via the 510(k) pathway on July 22, 2003. It is manufactured by Ekos and classified as a Class 2 device.
What It Is
The Ekos Peripheral Infusion System is a catheter-based device designed to deliver thrombolytic agents directly to thrombi, using ultrasound to enhance drug penetration and clot dissolution. It is intended for use in the treatment of venous thromboembolism, including deep vein thrombosis and acute limb ischemia.
Clinical Applications
This device is commonly used in clinical settings for patients with acute limb ischemia and deep vein thrombosis. It is particularly useful in scenarios where rapid clot dissolution is necessary to restore blood flow and prevent tissue damage.
Evidence Summary
The available literature includes a mix of randomized controlled trials, prospective, and retrospective studies, with a total of 8 studies reviewed. The studies span from 2013 to 2025, focusing on the efficacy and safety of ultrasound-assisted thrombolysis.
Reported Outcomes
Published studies report that the Ekos Peripheral Infusion System is effective in enhancing thrombolysis in acute limb ischemia and chronic deep vein thrombosis. The use of ultrasound-assisted thrombolysis has been associated with improved rates of limb salvage and reduced amputation rates in acute limb ischemia.
Safety Profile
Reported complications include bleeding events, which are common with thrombolytic therapy. However, the studies reviewed did not provide detailed safety data, indicating a need for further research on adverse events.
Evidence Limitations
The evidence is limited by the small number of studies specifically focusing on the Ekos Peripheral Infusion System. Many studies lack detailed safety outcomes, and further research is needed to establish long-term efficacy and safety profiles.
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 Peripheral Infusion System?
The device is indicated for mechanical thrombectomy in venous applications, particularly in acute limb ischemia and deep vein thrombosis.
What outcomes have been reported in clinical studies?
Studies have reported improved limb salvage rates and reduced amputation rates in patients with acute limb ischemia using ultrasound-assisted thrombolysis.
What complications have been reported?
Reported complications include bleeding events, which are a common risk associated with thrombolytic therapy.
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.