embozene color-advanced microspheres
Boston Scientific
FDA Clearance Information
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
Clinical Applications
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Linked Studies (12)
Sex-Related Differences among Adults with Hypertrophic Obstructive Cardiomyopathy Undergoing Transcoronary Ablation of Septal Hypertrophy.
Journal of clinical medicine
View Source →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 →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 →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 →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 →Ophthalmic artery occlusion following neuro-embolization of the external carotid artery, a case report.
BMC ophthalmology
Case Report View Source →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 →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 →Midterm results of uterine artery embolization using narrow-size calibrated embozene microspheres.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →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 →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 →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.