📊 Evidence-Based Reference

embozene color-advanced microspheres

Boston Scientific

Summary: Embozene Color-Advanced Microspheres are embolic agents used primarily for arterial embolization in various clinical settings. Key evidence highlights their efficacy in uterine artery embolization and transcatheter arterial chemoembolization.

FDA Clearance Information

Pathway 510K
Decision Date April 19, 2018
Product Code NOY
Device Class Class 2
Evidence 12 studies

The Embozene Color-Advanced Microspheres were cleared by the FDA through the 510(k) pathway on April 19, 2018. Manufactured by Boston Scientific, they are classified as Class 2 medical devices.

What It Is

Embozene Color-Advanced Microspheres are embolic agents designed for precise arterial embolization. They are used to occlude blood vessels in order to treat conditions such as tumors and uterine fibroids.

Clinical Applications

These microspheres are commonly used in procedures like uterine artery embolization and transcatheter arterial chemoembolization. They are employed in scenarios requiring targeted vessel occlusion to manage bleeding or reduce tumor blood supply.

Evidence Summary

The literature includes 15 studies, comprising RCTs, prospective, and retrospective analyses, published between 2018 and 2025. These studies explore various clinical applications and outcomes of using Embozene microspheres.

Reported Outcomes

Published studies report that Embozene microspheres are effective in reducing symptoms of uterine fibroids and adenomyosis when used in uterine artery embolization. They have also shown efficacy in transcatheter arterial chemoembolization for hepatocellular carcinoma, with outcomes indicating significant tumor necrosis.

Safety Profile

Reported complications include minor post-procedural pain and transient inflammatory responses. Overall, the safety profile is consistent with other embolic agents, with no significant long-term adverse events reported in the studies.

Evidence Limitations

Current evidence is limited by the variability in study design and small sample sizes in some studies. Further research is needed to establish long-term outcomes and compare efficacy across different embolic agents.

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 Color-Advanced Microspheres?

Embozene microspheres are indicated for use in arterial embolization procedures, such as uterine artery embolization for fibroids and transcatheter arterial chemoembolization for liver tumors.

What outcomes have been reported in clinical studies?

Studies have reported effective symptom relief in uterine fibroid embolization and significant tumor necrosis in liver cancer treatments using Embozene microspheres.

What complications have been reported?

Safety data indicate minor post-procedural pain and transient inflammatory responses, with no significant long-term adverse events reported.

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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