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embozene microspheres

Celonova Biosciences

Summary: Embozene Microspheres are embolization devices used primarily for vascular occlusion in various clinical settings. Key evidence highlights their efficacy in procedures like prostatic artery embolization and transcatheter arterial chemoembolization.

FDA Clearance Information

Pathway 510K
Number K132675 ↗
Decision Date October 3, 2013
Product Code KRD
Device Class Class 2
Evidence 12 studies

Embozene Microspheres received FDA 510k clearance on October 3, 2013. Manufactured by Celonova Biosciences, they are classified as Class 2 medical devices under product code KRD.

What It Is

Embozene Microspheres are spherical embolic agents designed for precise vascular occlusion. They are used in interventional radiology to block blood flow to targeted areas, aiding in the treatment of conditions such as tumors and vascular malformations.

Clinical Applications

Commonly used in procedures like transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma and prostatic artery embolization for prostate cancer. They are also applied in genicular artery embolization for knee osteoarthritis.

Evidence Summary

The literature includes 15 studies, comprising randomized controlled trials, prospective studies, and case reports, published between 2017 and 2024. These studies explore various clinical applications and outcomes of Embozene Microspheres.

Reported Outcomes

Published studies report that Embozene Microspheres are effective in reducing tumor size in hepatocellular carcinoma and alleviating symptoms in knee osteoarthritis. They have also shown promise in managing advanced prostate cancer through prostatic artery embolization.

Safety Profile

Reported complications include ophthalmic artery occlusion following neuro-embolization and other procedure-related adverse events. Safety profiles vary depending on the clinical application and patient population.

Evidence Limitations

Current evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to fully understand the comparative efficacy of Embozene Microspheres against other embolic agents and their long-term safety profile.

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 are the clinical indications for Embozene Microspheres?

Embozene Microspheres are indicated for use in embolization procedures such as transcatheter arterial chemoembolization and prostatic artery embolization.

What outcomes have been reported in clinical studies?

Studies have reported positive outcomes in tumor size reduction and symptom alleviation in conditions like hepatocellular carcinoma and knee osteoarthritis.

What complications have been reported?

Safety data indicate complications such as ophthalmic artery occlusion and other procedure-related adverse events.

Related Device Categories

Embolization Microspheres
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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