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ekosonic mach 4 endovascular device ekosonic control unit

Btg International

Summary: The Ekosonic Mach 4 Endovascular Device is used for mechanical thrombectomy in venous systems. It is primarily utilized by interventional radiologists and vascular surgeons to treat patients with venous thromboembolism.

FDA Clearance Information

Pathway 510K
Decision Date May 21, 2014
Product Code QEY
Device Class Class 2
Evidence 35 studies

The Ekosonic Mach 4 Endovascular Device by Btg International was cleared through the FDA 510k pathway on May 21, 2014. It is a Class 2 medical device under product code QEY.

What It Is

The Ekosonic Mach 4 Endovascular Device is a specialized tool designed for the mechanical removal of thrombi from venous systems. It operates by using ultrasound-assisted catheter-directed thrombolysis, which enhances the penetration of thrombolytic agents into the clot, facilitating its dissolution. This device is particularly useful in cases where rapid clot resolution is necessary to restore venous flow and prevent complications.

Clinical Applications

This device is commonly used in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), particularly in patients who are at high risk for complications from these conditions. It is typically employed in hospital settings, such as interventional radiology suites or vascular surgery departments. The patient population includes those with acute venous thromboembolism who require expedited clot removal to alleviate symptoms and prevent further complications.

Indications for Use

The FDA-cleared indications for this device include the treatment of venous thromboembolism, such as deep vein thrombosis and pulmonary embolism. It is intended for patients who need mechanical intervention to remove clots from their venous systems.

Practical Considerations

When using the Ekosonic Mach 4, clinicians should consider the size of the affected vessel and the extent of the thrombus to select the appropriate catheter size. The device is compatible with standard thrombolytic agents, and its use requires familiarity with catheter-directed thrombolysis techniques.

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 is the Ekosonic Mach 4 Endovascular Device used for?

The device is used for the mechanical removal of thrombi in venous systems, particularly in cases of deep vein thrombosis and pulmonary embolism.

What specialties typically use this device?

Interventional radiologists and vascular surgeons typically use this device in hospital settings.

What are the FDA-cleared indications?

The device is indicated for the treatment of venous thromboembolism, including deep vein thrombosis and pulmonary embolism.

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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