đź“‹ FDA Reference

embozene color-advanced microspheres embozene opaque non-colored microspheres

Celonova Biosciences

Summary: Embozene Microspheres are used for embolization procedures to block blood flow to specific areas. They are typically used by interventional radiologists in various clinical settings.

FDA Clearance Information

Pathway 510K
Decision Date February 24, 2014
Product Code NAJ
Device Class Class 2
Evidence 12 studies

The Embozene Microspheres by Celonova Biosciences were cleared through the FDA 510(k) pathway on February 24, 2014. They are classified as Class 2 medical devices.

What It Is

Embozene Microspheres are small, spherical particles used in embolization procedures to occlude blood vessels. They are designed to be injected into the bloodstream, where they travel to a target site and block blood flow, effectively starving tissues or tumors of nutrients. The device is available in various sizes, allowing for precise targeting of different vessel calibers.

Clinical Applications

Embozene Microspheres are commonly used in interventional radiology for procedures such as uterine fibroid embolization, treatment of hypervascular tumors, and arteriovenous malformations. They are utilized in hospital settings, often in the radiology department, and are suitable for adult patients requiring targeted embolization therapy.

Indications for Use

The FDA-cleared indications for Embozene Microspheres include their use in embolization procedures to occlude blood flow to specific areas, such as tumors or abnormal vascular formations. This is particularly useful in managing conditions like uterine fibroids or certain types of cancer.

Practical Considerations

Embozene Microspheres come in various sizes to accommodate different vessel diameters, ensuring precise embolization. They are compatible with standard microcatheters used in interventional radiology. Clinicians should consider the size and location of the target vessels when selecting the appropriate microsphere size.

Linked Studies (12)

PubMed • 2023

Sex-Related Differences among Adults with Hypertrophic Obstructive Cardiomyopathy Undergoing Transcoronary Ablation of Septal Hypertrophy.

Journal of clinical medicine

View Source →
PubMed • 2023

Genicular Artery Embolisation in Patients with Osteoarthritis of the Knee (GENESIS 2): Protocol for a Double-Blind Randomised Sham-Controlled Trial.

Cardiovascular and interventional radiology

View Source →
PubMed • 2022

Randomised Controlled Trial of Particles Used in Uterine fibRoid Embolisation (PURE): Non-Spherical Polyvinyl Alcohol Versus Calibrated Microspheres.

Cardiovascular and interventional radiology

RCT View Source →
PubMed • 2020

Comparison of the Efficacy of Two Microsphere Embolic Agents for Transcatheter Arterial Chemoembolization in Hepatocellular Carcinoma Patients.

Cancer research and treatment

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2019

Comparison of microsphere penetration with LC Bead LUMI™ versus other commercial microspheres.

Journal of the mechanical behavior of biomedical materials

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2017

Ophthalmic artery occlusion following neuro-embolization of the external carotid artery, a case report.

BMC ophthalmology

Case Report View Source →
PubMed • 2016

Parasagittal Dural Arteriovenous Fistula Treated With Embozene Microspheres.

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

Other View Source →
PubMed • 2013

Embozene™ microspheres induced nonreperfused myocardial infarction in an experimental swine model.

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2011

Midterm results of uterine artery embolization using narrow-size calibrated embozene microspheres.

Cardiovascular and interventional radiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2011

The arterial distribution of Embozene and Embosphere microspheres in sheep kidney and uterus embolization models.

Journal of vascular and interventional radiology : JVIR

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2010

Arterial distribution characteristics of Embozene particles and comparison with other spherical embolic agents in the porcine acute embolization model.

Journal of vascular and interventional radiology : JVIR

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2009

Experimental liver embolization with four different spherical embolic materials: impact on inflammatory tissue and foreign body reaction.

Cardiovascular and interventional radiology

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

Frequently Asked Questions

What is Embozene Microspheres used for?

Embozene Microspheres are used for embolization procedures to block blood flow to specific areas, such as tumors or abnormal blood vessels.

What specialties typically use this device?

Interventional radiologists primarily use Embozene Microspheres during embolization procedures.

What are the FDA-cleared indications?

The FDA-cleared indications include use in embolization procedures to occlude blood flow to specific areas, such as tumors or abnormal vascular formations.

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.

📬 Stay Updated

Get the latest vascular education content delivered to your inbox.