đź“Š Evidence-Based Reference
ekos peripheral infusion system
Ekos
Summary: The Ekos Peripheral Infusion System is a catheter-based device used for ultrasound-assisted thrombolysis in treating thrombotic conditions. Key evidence highlights its use in acute limb ischemia and deep vein thrombosis.
FDA Clearance Information
Pathway 510K
Number K050563 ↗
Decision Date March 29, 2005
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 March 29, 2005. 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 for ultrasound-assisted thrombolysis. It is intended for use in the treatment of thrombotic conditions, enhancing the delivery of thrombolytic agents to the site of a clot.
Clinical Applications
Common clinical scenarios for the Ekos Peripheral Infusion System include the treatment of acute limb ischemia and deep vein thrombosis. It is used in settings where enhanced thrombolysis is required to restore blood flow.
Evidence Summary
The available literature includes a mix of RCTs, prospective, and retrospective studies, with a total of 8 studies identified. The studies range from 2013 to 2025, focusing on the device's efficacy and safety.
Reported Outcomes
Published studies report that the Ekos Peripheral Infusion System is effective in improving limb salvage rates and reducing amputation in acute limb ischemia. It has also shown efficacy in treating chronic deep vein thrombosis with ultrasound-accelerated thrombolysis.
Safety Profile
Reported complications include bleeding events associated with thrombolytic therapy. The safety profile is consistent with other catheter-directed thrombolysis systems, with no unique adverse events reported.
Evidence Limitations
Evidence gaps include a lack of large-scale randomized controlled trials directly comparing the Ekos system to other thrombolysis methods. Further research is needed to establish long-term outcomes and optimal patient selection criteria.
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 use in mechanical thrombectomy for venous conditions, particularly 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 acute limb ischemia, as well as efficacy in treating chronic deep vein thrombosis.
What complications have been reported?
Reported complications include bleeding events, which are common with thrombolytic therapy, but no unique adverse events specific to the Ekos system have been noted.
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.