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.
Clear Filters
DeviceManufacturerPathwayClearedEvidence
embosphere microspheres EvidenceBiosphere Medical510K2017 16
embosphere microspheres EvidenceBiosphere Medical510K2025 16
embosphere microspheres EvidenceBiosphere Medical510K2000 16
embosphere microspheres and embogold microspheres for use in uterine fibroid embolization EvidenceBiosphere Medical510K2002 16
embosphere microspheres EvidenceBiosphere Medical510K2018 16
embozene color-advanced microspheres embozene opaque non-colored microspheres oncozene microspheres Celonova Biosciences510K2014 12
embozene color-advanced microspheres EvidenceBoston Scientific510K2018 12
embozene microspheres EvidenceCelonova Biosciences510K2008 12
embozene color-advanced microspheres EvidenceVarian Medical Systems510K2025 12
embozene microspheres EvidenceCelonova Biosciences510K2013 12
embozene color-advanced microspheres embozene opaque non-colored microspheres Celonova Biosciences510K2014 12
sir-spheres microspheres activity calculator smac Sirtex Medical Us Holdings510K2020 11
sir-spheres microspheres EvidenceSirtex MedicalPMA2015 11
hepasphere microspheres EvidenceBiosphere Medical510K2006 8
lc bead lumi EvidenceBiocompatibles Uk510K2016 7
lc bead lumi EvidenceBiocompatibles Uk510K2015 7
lc bead microspheres bead block compressible microspheres EvidenceBiocompatibles Uk510K2008 4
lc bead microspheres bead block compressible microspheres EvidenceBiocompatibles Uk510K2010 4
gelspheres microspheres and bead block compressible microspheres EvidenceBiocompatibles Uk510K2004 4
allocraft dbm Lifecell510K2005 β€”
dbx strip Musculoskeletal Transplant Foundation510K2007 β€”
albunex r echocardiography contrast microspheres EvidenceMolecular BiosystemsPMA1996 β€”
accell tbm-r EvidenceIsotis Orthobiologics510K2008 β€”
progenix dbm putty and paste Medtronic Sofamor Danek510K2006 β€”
embogold microsphere EvidenceBiosphere Medical510K2001 β€”
quadrasphere microspheres EvidenceBiosphere Medical510K2017 β€”
easi-vue r embolic microspheres system EvidenceAbk Biomedical510K2024 β€”
sygnal dbm Musculoskeletal Transplant Foundation510K2008 β€”
viagraf dbm paste EvidenceOsteotech510K2005 β€”
optecure optecure ccc EvidenceExactech510K2007 β€”
oncozene microspheres 40um 2ml oncozene microspheres 75um 2ml oncozene microspheres 100um 2ml oncozene microsphere Celonova Biosciences510K2013 β€”
vivorte trabexus eb Vivorte510K2015 β€”
hrspheres narrow-size embolic microspheres EvidenceSuzhou Hengrui Hongyuan Medical510K2021 β€”
hydropearl microspheres EvidenceMicrovention510K2020 β€”
unipearls r embolic microspheres Suzhou Haowei Medical Technology510K2023 β€”
accell evo3 formerly accell a2i Integra Life Sciences510K2011 β€”
m-bolus embolic microspheres Scion Cardio-Vascular510K2006 β€”
osteoset dbm pellets EvidenceWrightmedicaltechnology510K2006 β€”
easi-vue embolic microspheres system EvidenceAbk Biomedical510K2022 β€”
quadrasphere microspheres EvidenceBiosphere Medical510K2015 β€”
contour se microspheres EvidenceBoston Scientific510K2002 β€”
bioset xc Regeneration Technologies510K2006 β€”
dbx-h hemostatic demineralized bone matrix putty EvidenceOrthocon510K2007 β€”
cleared under grafton ii edbm Medtronic Sofamor Danek510K2013 β€”
orthoblast ii putty and paste Isotis Orthobiologics510K2005 β€”
vivorte bvf Vivorte510K2013 β€”
dsm biomedical calcium phosphate cement with microspheres Kensey Nash Corporation Dba Dsm Biomedical510K2018 β€”
pliafx flo EvidenceLifenet Health510K2024 β€”
sygnal dbm Musculoskeletal Transplant Foundation510K2008 β€”
optecure ccc Exactech510K2006 β€”

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.

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