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Embosphere Microspheres
Summary: Embosphere Microspheres are used for embolization procedures, primarily in uterine fibroids and knee osteoarthritis. Key evidence shows efficacy in genicular artery embolization and uterine artery embolization.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K250971 ↗
Decision Date ?
May 16, 2025
Product Code ?
KRD Device, Vascular, For Promoting Embolization
Device Class ?
Class 2
Evidence ?
16 studies
Embosphere Microspheres received FDA clearance through the 510(k) pathway on May 16, 2025. Manufactured by Biosphere Medical, they are classified as Class 2 devices.
What It Is
Embosphere Microspheres are gelatin-based embolic agents designed for use in embolization procedures. They are intended to occlude blood vessels to reduce blood flow to target tissues, commonly used in interventional radiology.
FDA-Cleared Indications
- For use in vascular embolization procedures when temporary or permanent reduction of blood flow to a selected vascular bed is needed.
- For use by appropriately trained clinicians to occlude blood vessels during indicated embolization procedures.
Clinical Applications
- Vascular embolization to reduce blood flow to a selected target tissue or vascular bed.
- Embolization procedures performed under image guidance by interventional specialists.
Reported off-label uses
- Uterine artery embolization for symptomatic uterine fibroids.
- Genicular artery embolization for selected patients with knee osteoarthritis.
- Bronchial artery embolization for management of hemoptysis.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials and retrospective analyses, conducted between 2023 and 2025. These studies evaluate the efficacy and safety of Embosphere Microspheres in various embolization procedures.
Reported Outcomes
Published studies report that Embosphere Microspheres are effective in reducing symptoms in uterine fibroid embolization and knee osteoarthritis. They have shown comparable efficacy to other embolic agents in genicular and uterine artery embolization.
Safety Profile
Reported complications include transient pain and post-embolization syndrome. No significant long-term adverse events have been consistently reported across studies.
Evidence Limitations
Current evidence is limited by small sample sizes and short follow-up durations. Further research is needed to assess long-term outcomes and compare efficacy with newer embolic agents.
Practical Considerations
- Microsphere size should be selected according to the target vessel, desired level of embolization, vascular anatomy and risk of non-target embolization.
- The product must be prepared and injected according to its current instructions for use, using compatible catheters and imaging guidance.
- Clinicians should evaluate for contraindications, including uncorrectable coagulopathy, severe infection in the treatment area, unsuitable vascular anatomy and known hypersensitivity to product components.
- MRI safety and conditional-use information should be confirmed in the current FDA-cleared labeling and manufacturer instructions before MRI.
- Embolization may be permanent and can cause ischemia, non-target embolization, pain, bleeding, infection or tissue injury; alternatives may include medication, surgery or other embolic agents depending on the condition.
Linked Studies (16)
PubMed • 2025
Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study Protocol Summary.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Uterine artery embolization in sheep: comparison of acute effects with Embosphere microspheres and Embosoft microspheres.
Acta radiologica (Stockholm, Sweden : 1987)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparison of the Efficacy of Polyvinyl Alcohol Colorless Embolic Microspheres (8Spheres) and Gelatin Embolic Microspheres (Embosphere) in Uterine Artery Embolization for Symptomatic Uterine Fibroids in Women Without Fertility Requirements: A Multicenter Observational Study.
International journal of women's health
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Embosphere microspheres size for bronchial artery embolization in patients with hemoptysis caused by bronchiectasis: a retrospective comparative analysis of 500-750 versus 700-900 μm microspheres.
BMC pulmonary medicine
Retrospective View Source →PubMed • 2023
Two-year outcomes comparing Embosphere® microspheres versus Imipenem Cilastatin for genicular artery embolization in patients with moderate to severe knee osteoarthritis.
The Knee
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Clinical Study on the Treatment of Benign Prostatic Hyperplasia by Embolization of Prostate Artery Based on Embosphere Microspheres and Gelatin Sponge Granules.
Journal of healthcare engineering
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Embolization of Skull Base Meningiomas with Embosphere Microspheres: Factors Predicting Treatment Response and Evaluation of Complications.
World neurosurgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2021
Investigation of the Physical Properties and Clinical Application of Embosphere Microspheres.
Chemotherapy
RCT|prospective|retrospective|case Series|other 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 • 2017
Prostatic Artery Embolization Using Embosphere Microspheres for Prostates Measuring 80-150 cm(3): Early Results from a US Trial.
Journal of vascular and interventional radiology : JVIR
View Source →PubMed • 2012
Comparison of clinical and MR imaging outcomes after uterine fibroid embolization with Bead Block and Embosphere.
European journal of 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 • 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 →PubMed • 2005
Preoperative embolization of intracranial meningiomas with Embosphere microspheres.
Minimally invasive neurosurgery : MIN
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
View Source →Frequently Asked Questions
What are the clinical indications for Embosphere Microspheres?
Embosphere Microspheres are indicated for use in embolization procedures such as uterine artery embolization for fibroids and genicular artery embolization for knee osteoarthritis.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective symptom reduction in uterine fibroid and knee osteoarthritis embolization, with outcomes comparable to other embolic agents.
What complications have been reported?
Safety data indicate transient pain and post-embolization syndrome as common complications, 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.