đź“‹ FDA Reference

embozene color-advanced microspheres embozene opaque non-colored microspheres oncozene microspheres

Celonova Biosciences

Summary: Embozene Microspheres are used for embolization procedures to block blood flow to specific areas, often in tumor treatment. They are utilized by interventional radiologists and oncologists.

FDA Clearance Information

Pathway 510K
Decision Date August 7, 2014
Product Code KRD
Device Class Class 2
Evidence 12 studies

Embozene Microspheres were cleared via the FDA 510(k) pathway on August 7, 2014. Manufactured by Celonova Biosciences, this Class 2 device is used for embolization procedures.

What It Is

Embozene Microspheres are small, spherical particles used in embolization, a procedure to block blood flow to certain areas of the body. These microspheres are available in various sizes and are designed to occlude blood vessels, effectively starving tumors of their blood supply. The color-advanced and opaque versions aid in visualization during procedures.

Clinical Applications

Commonly used in interventional radiology, Embozene Microspheres are employed in procedures to treat hypervascular tumors, uterine fibroids, and arteriovenous malformations. They are particularly useful in oncology settings for transarterial chemoembolization (TACE) to treat liver cancer. The device is applicable in both hospital and outpatient settings, catering to adult patients with specific vascular conditions.

Indications for Use

The FDA-cleared indications for Embozene Microspheres include embolization of hypervascular tumors and arteriovenous malformations. This means they are used to block blood flow to abnormal blood vessels or tumors, reducing their size or growth.

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 procedures. 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 to block blood flow to hypervascular tumors and arteriovenous malformations.

What specialties typically use this device?

Interventional radiologists and oncologists typically use Embozene Microspheres in embolization procedures.

What are the FDA-cleared indications?

The FDA-cleared indications include embolization of hypervascular tumors and arteriovenous malformations.

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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