📊 Evidence-Based Reference

ekosonic endovascular device

Boston Scientific

Summary: The Ekosonic Endovascular Device is used for ultrasound-assisted thrombolysis in vascular conditions. It is primarily used in cases of acute pulmonary embolism and limb ischemia. Key evidence highlights its efficacy in resolving ischemia and restoring normal blood flow.

FDA Clearance Information

Pathway 510K
Decision Date November 19, 2021
Product Code QEY
Device Class Class 2
Evidence 35 studies

The Ekosonic Endovascular Device was cleared by the FDA through the 510(k) pathway on November 19, 2021. It is manufactured by Boston Scientific and classified as a Class 2 device.

What It Is

The Ekosonic Endovascular Device is a catheter-based system designed for ultrasound-assisted thrombolysis. It is intended for the controlled infusion of thrombolytics into the peripheral vasculature and pulmonary arteries, aiding in the dissolution of thrombi.

Clinical Applications

Commonly used in the management of acute pulmonary embolism and acute limb ischemia, the device facilitates thrombolysis in patients who are hemodynamically unstable or at risk of vascular complications. It is often employed in conjunction with other supportive measures like ECMO.

Evidence Summary

The literature includes 15 studies, comprising case series and other study types, published between 2020 and 2022. These studies explore the device's efficacy and safety in various clinical scenarios, focusing on thrombolysis outcomes.

Reported Outcomes

Published studies report that the Ekosonic Endovascular Device effectively resolves ischemia and restores normal blood flow in affected arteries. In cases of acute limb ischemia, symptoms were resolved, and angiographic control showed normal flow. The device has also been used successfully in pulmonary embolism cases, contributing to right ventricular recovery.

Safety Profile

Reported complications include local deficits, although patients were discharged without any long-term deficits. The safety profile is generally favorable, with no significant adverse events reported in the available studies.

Evidence Limitations

The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and to compare the device's efficacy with other thrombolytic strategies.

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 Device?

The device is indicated for ultrasound-assisted thrombolysis in cases of acute pulmonary embolism and acute limb ischemia.

What outcomes have been reported in clinical studies?

Clinical studies have reported successful resolution of ischemia and restoration of normal blood flow in affected arteries.

What complications have been reported?

Reported complications include local deficits, but patients were generally discharged without long-term issues.

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.

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