Embolization Microspheres
75 devices
31 with evidence
Clinical Overview
Embolization microspheres are used in interventional radiology to occlude blood vessels, primarily to treat hypervascular tumors, arteriovenous malformations, and uterine fibroids. These devices address clinical problems such as excessive bleeding and tumor growth by reducing blood supply to the target area. Patients who typically require these devices include those with liver cancer, uterine fibroids, or gastrointestinal bleeding. Interventional radiologists and vascular specialists are the primary users of embolization microspheres.
| Device | Manufacturer | Pathway | Cleared | Evidence |
|---|---|---|---|---|
| Embosphere Microspheres Evidence | Biosphere Medical | 510(k) | 2025 | 16 |
| Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization Evidence | Biosphere Medical | 510(k) | 2002 | 16 |
| Embozene Color-Advanced Microspheres Embozene Opaque Non-Colored Microspheres Oncozene Microspheres | Celonova Biosciences | 510(k) | 2014 | 12 |
| Embozene Color-Advanced Microspheres Evidence | Boston Scientific | 510(k) | 2018 | 12 |
|
Embozene Microspheres
Evidence
Other clearances:
2008
|
Celonova Biosciences | 510(k) | 2013 | 12 |
| Embozene Color-Advanced Microspheres Evidence | Varian Medical Systems | 510(k) | 2025 | 12 |
| Embozene Color-Advanced Microspheres Embozene Opaque Non-Colored Microspheres | Celonova Biosciences | 510(k) | 2014 | 12 |
| SIR-Spheres Microspheres Activity Calculator Smac | Sirtex Medical Us Holdings | 510(k) | 2020 | 11 |
| SIR-Spheres Microspheres Evidence | Sirtex Medical | PMA | 2015 | 11 |
| HepaSphere Microspheres Evidence | Biosphere Medical | 510(k) | 2006 | 8 |
|
LC Bead Lumi
Evidence
Other clearances:
2015
|
Biocompatibles Uk | 510(k) | 2016 | 7 |
|
LC Bead Microspheres Bead Block Compressible Microspheres
Evidence
Other clearances:
2008
|
Biocompatibles Uk | 510(k) | 2010 | 4 |
| Gelspheres Microspheres and Bead Block Compressible Microspheres Evidence | Biocompatibles Uk | 510(k) | 2004 | 4 |
| Allocraft Dbm | Lifecell | 510(k) | 2005 | — |
| Dbx Strip | Musculoskeletal Transplant Foundation | 510(k) | 2007 | — |
| Albunex R Echocardiography Contrast Microspheres Evidence | Molecular Biosystems | PMA | 1996 | — |
| Accell Tbm-R Evidence | Isotis Orthobiologics | 510(k) | 2008 | — |
| Progenix Dbm Putty and Paste | Medtronic Sofamor Danek | 510(k) | 2006 | — |
| Embogold Microsphere Evidence | Biosphere Medical | 510(k) | 2001 | — |
|
Quadrasphere Microspheres
Evidence
Other clearances:
2015
|
Biosphere Medical | 510(k) | 2017 | — |
| Easi-Vue R Embolic Microspheres System Evidence | Abk Biomedical | 510(k) | 2024 | — |
|
Sygnal Dbm
Other clearances:
2008
|
Musculoskeletal Transplant Foundation | 510(k) | 2008 | — |
| Viagraf Dbm Paste Evidence | Osteotech | 510(k) | 2005 | — |
| Optecure Optecure Ccc Evidence | Exactech | 510(k) | 2007 | — |
| Oncozene Microspheres 40um 2ml Oncozene Microspheres 75um 2ml Oncozene Microspheres 100um 2ml Oncozene Microsphere | Celonova Biosciences | 510(k) | 2013 | — |
| Vivorte Trabexus Eb | Vivorte | 510(k) | 2015 | — |
| Hrspheres Narrow-Size Embolic Microspheres Evidence | Suzhou Hengrui Hongyuan Medical | 510(k) | 2021 | — |
| HydroPearl Microspheres Evidence | Microvention | 510(k) | 2020 | — |
| Unipearls R Embolic Microspheres | Suzhou Haowei Medical Technology | 510(k) | 2023 | — |
| Accell EVO3 Formerly Accell A2I | Integra Life Sciences | 510(k) | 2011 | — |
| M-Bolus Embolic Microspheres | Scion Cardio-Vascular | 510(k) | 2006 | — |
| Osteoset Dbm Pellets Evidence | Wrightmedicaltechnology | 510(k) | 2006 | — |
| Easi-Vue Embolic Microspheres System Evidence | Abk Biomedical | 510(k) | 2022 | — |
| Contour Se Microspheres Evidence | Boston Scientific | 510(k) | 2002 | — |
| Bioset Xc | Regeneration Technologies | 510(k) | 2006 | — |
| Dbx-H Hemostatic Demineralized Bone Matrix Putty Evidence | Orthocon | 510(k) | 2007 | — |
| Cleared Under Grafton II Edbm | Medtronic Sofamor Danek | 510(k) | 2013 | — |
| Orthoblast II Putty and Paste | Isotis Orthobiologics | 510(k) | 2005 | — |
| Vivorte Bvf | Vivorte | 510(k) | 2013 | — |
| Dsm Biomedical Calcium Phosphate Cement with Microspheres | Kensey Nash Corporation Dba Dsm Biomedical | 510(k) | 2018 | — |
| Pliafx Flo Evidence | Lifenet Health | 510(k) | 2024 | — |
| Optecure Ccc | Exactech | 510(k) | 2006 | — |
Evidence Landscape
The clinical evidence for embolization microspheres includes randomized controlled trials (RCTs), registry data, and case series. Outcomes typically measured are efficacy in occlusion, safety profiles, and long-term patient outcomes. Evidence is strongest in the treatment of uterine fibroids and liver tumors, while more research is needed in other applications.
Device Landscape
Embolization microspheres can be categorized into several subtypes, including resorbable and non-resorbable microspheres. Key differentiating features include size, material composition, and color visibility under imaging. These variations allow for tailored treatment approaches depending on the clinical scenario and patient-specific anatomy.
Clinical Workflow Considerations
Embolization procedures using microspheres are typically performed in an interventional radiology suite. Clinicians must consider patient-specific anatomy and pathology when selecting devices. Training in catheter techniques and familiarity with imaging modalities are essential for successful outcomes. Setup requirements include appropriate imaging equipment and access to a range of microsphere sizes.
Frequently Asked Questions
What are embolization microspheres used for?
Embolization microspheres are primarily used to occlude blood vessels in the treatment of hypervascular tumors, arteriovenous malformations, and uterine fibroids, reducing blood supply to these areas.
What clinical evidence is available for embolization microspheres?
The evidence landscape includes RCTs, registry data, and case series, with strong evidence supporting their use in uterine fibroids and liver tumors. Studies often focus on efficacy, safety, and long-term outcomes.
How do I choose between different embolization microspheres?
Clinicians consider factors such as patient-specific anatomy, the target vessel size, and institutional preferences when choosing between different microspheres.
What complications are associated with embolization microspheres?
Common complications include post-embolization syndrome, non-target embolization, and vessel perforation. Serious complications are rare but can include infection and tissue necrosis.
What training is required for embolization microspheres?
Training typically involves a fellowship in interventional radiology, with specific competency in catheter techniques and imaging modalities for safe and effective use of embolization microspheres.