📊 Evidence-Based Reference

embozene color-advanced microspheres

Varian Medical Systems

FDA Clearance Information

Pathway 510K

Number K242608 ↗

Decision Date January 17, 2025

Product Code KRD

Device Class Class 2

Evidence 12 studies

The Embozene Color-Advanced Microspheres were cleared by the FDA through the 510(k) pathway on January 17, 2025. Manufactured by Varian Medical Systems, they are classified as a Class 2 medical device.

What It Is

Embozene Color-Advanced Microspheres are embolic agents designed for vascular embolization. They are used to occlude blood vessels in order to reduce blood flow to specific areas, aiding in the treatment of conditions such as fibroids and other vascular abnormalities.

Clinical Applications

Commonly used in uterine artery embolization for fibroids and adenomyosis, these microspheres are also applied in procedures like prostatic artery embolization and genicular artery embolization for pain management. They provide a minimally invasive option for managing various vascular conditions.

Evidence Summary

The literature includes 15 studies ranging from randomized controlled trials to systematic reviews, published between 2022 and 2025. These studies explore the efficacy and safety of the microspheres in different clinical settings.

Reported Outcomes

Published studies report that Embozene Color-Advanced Microspheres are effective in reducing symptoms associated with uterine fibroids and adenomyosis. They have also shown promise in managing chronic musculoskeletal pain and osteoarthritis-related knee pain. Efficacy in prostatic artery embolization for prostate cancer has been noted in pilot studies.

Safety Profile

Reported complications include minor adverse events such as post-embolization syndrome, which is generally self-limiting. Serious complications are rare but can include non-target embolization and infection.

Evidence Limitations

Current evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term outcomes and to explore the full range of potential applications for these microspheres.

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?

They are indicated for use in embolization procedures, including uterine artery embolization for fibroids and adenomyosis, and other vascular interventions.

What outcomes have been reported in clinical studies?

Studies have reported symptom reduction in uterine fibroids, adenomyosis, and chronic pain conditions. Efficacy in prostate cancer management has also been noted.

What complications have been reported?

Safety data indicates minor complications like post-embolization syndrome, with rare occurrences of serious events such as non-target embolization.

Related Device Categories

Embolization Microspheres