📊 Evidence-Based Reference

onyx liquid embolic system

Ev3 Neurovascular

Summary: The Onyx Liquid Embolic System is a device used for embolization procedures, primarily in neurovascular applications. Key evidence highlights its efficacy in embolizing the middle meningeal artery and other vascular structures.

FDA Clearance Information

Pathway PMA
Decision Date June 6, 2019
Product Code MFE
Device Class Class 3
Evidence 40 studies

The Onyx Liquid Embolic System was cleared by the FDA via the PMA pathway on June 6, 2019. It is manufactured by Ev3 Neurovascular and is classified as a Class 3 device.

What It Is

The Onyx Liquid Embolic System is a liquid embolic agent composed of ethylene vinyl alcohol copolymer dissolved in dimethyl sulfoxide (DMSO). It is used in endovascular embolization procedures to occlude blood vessels in the treatment of arteriovenous malformations and other vascular lesions.

Clinical Applications

Common clinical scenarios for the Onyx Liquid Embolic System include the embolization of arteriovenous malformations, dural arteriovenous fistulas, and other vascular abnormalities. It is often used when traditional surgical approaches are not feasible.

Evidence Summary

The available literature includes 15 studies, with a mix of randomized controlled trials, case series, and retrospective analyses. The studies span from 2017 to 2026, providing a comprehensive overview of the device's clinical applications.

Reported Outcomes

Published studies report that the Onyx Liquid Embolic System is effective in achieving vascular occlusion in various clinical settings, including the embolization of the middle meningeal artery for chronic subdural hematoma. The device has demonstrated good radiopacity and handling characteristics in clinical use.

Safety Profile

Reported complications include inflammatory changes and potential adverse reactions related to the embolic material. However, the studies did not provide detailed safety outcomes, indicating a need for further research into long-term safety profiles.

Evidence Limitations

The evidence base is limited by the lack of large-scale randomized controlled trials and detailed safety data. Further research is needed to establish long-term outcomes and to better understand the potential complications associated with the device.

Linked Studies (20)

PubMed • 2026

Peripheral Vasculature Embolization with the Onyx Liquid Embolic System in a Swine Model.

Journal of vascular and interventional radiology : JVIR

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Embolization of middle meningeal artery for chronic subdural hematoma: Do we have sufficient evidence?

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

View Source →
PubMed • 2025

Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.

Journal of neuroendovascular therapy

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent.

American heart journal

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

OnyxTMGel or Coil versus Hydrogel as Embolic Agents in Endovascular Applications: Review of the Literature and Case Series.

Gels (Basel, Switzerland)

View Source →
PubMed • 2024

The resolute Onyx in TIA management (ROTIA).

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Spinal tumor embolization with Onyx: A systematic review and meta-analysis.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Technical video: Onyx-18 embolization of spinal epidural arteriovenous Fistula using the scepter-Mini balloon catheter.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

DynamX sirolimus-eluting Bioadaptor versus the zotarolimus-eluting Resolute Onyx stent in patients with de novo coronary artery lesions: Design and rationale of the multi-center, international, randomized BIODAPTOR-RCT.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

Delayed Migration of Onyx Embolic Agent after Preoperative Embolization of an Arteriovenous Malformation in a Pediatric Patient: A Case Report and Review of the Literature.

Pediatric neurosurgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

The Era of Onyx Embolization: A Systematic and Literature Review of Preoperative Embolization Before Stereotactic Radiosurgery for the Management of Cerebral Arteriovenous Malformations.

World neurosurgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

Torcular dural AVF: Transvenous onyx embolisation with sinus reconstruction.

Clinical neurology and neurosurgery

View Source →
PubMed • 2023

Retrieval of a Fractured Marathon Microcatheter Entrapped in Onyx Using a Novel Stentriever-Assisted Technique.

Operative neurosurgery (Hagerstown, Md.)

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Onyx™ Cast Fragmentation After Embolization of Endoleaks.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Comparative Evaluation of Conventional and OnyxCeph™ Dental Software Measurements on Cephalometric Radiography.

Turkish journal of orthodontics

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2021

Dosimetric comparison of iPlanⓇ Pencil Beam (PB) and Monte Carlo (MC) algorithms in stereotactic radiosurgery/radiotherapy (SRS/SRT) plans of intracranial arteriovenous malformations.

Medical dosimetry : official journal of the American Association of Medical Dosimetrists

Retrospective View Source →
PubMed • 2021

Transradial middle meningeal artery embolization for chronic subdural hematoma using Onyx: case series.

Journal of neurointerventional surgery

Case Series View Source →
PubMed • 2020

Percutaneous transorbital embolization of a carotid cavernous fistula.

Proceedings (Baylor University. Medical Center)

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020

Comparison of short-term clinical outcomes between Resolute Onyx zotarolimus-eluting stents and everolimus-eluting stent in patients with acute myocardial infarction: Results from the Korea Acute Myocardial infarction Registry (KAMIR).

Cardiology journal

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020

Device profile of the Resolute Onyx Zotarolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy.

Expert review of medical devices

RCT|prospective|retrospective|case Series|other View Source →

Frequently Asked Questions

What are the clinical indications for Onyx Liquid Embolic System?

The device is indicated for the embolization of arteriovenous malformations and other vascular lesions where surgical intervention is not feasible.

What outcomes have been reported in clinical studies?

Studies have reported effective vascular occlusion and good handling characteristics, particularly in the embolization of the middle meningeal artery.

What complications have been reported?

Reported complications include inflammatory changes and potential adverse reactions, though detailed safety data is limited.

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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