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polyvinyl alcohol embolic microspheres
Canyon Medical
Summary: Polyvinyl alcohol embolic microspheres are used for embolization procedures, primarily in treating tumors and fibroids. Key evidence highlights their efficacy in transarterial radioembolization and uterine artery embolization.
FDA Clearance Information
Pathway
510K
Number
K250209 ↗
Decision Date
September 23, 2025
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on September 23, 2025, by Canyon Medical. It is classified as a Class 2 medical device.
What It Is
Polyvinyl alcohol embolic microspheres are small, synthetic particles used to block blood flow to specific areas, such as tumors, during embolization procedures. They are designed to occlude blood vessels, thereby reducing blood supply to targeted tissues.
Clinical Applications
Commonly used in procedures like transarterial chemoembolization for liver cancer and uterine artery embolization for fibroids, these microspheres help in reducing tumor size and alleviating symptoms by obstructing blood flow.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2024 and 2025. These studies explore the efficacy and safety of polyvinyl alcohol microspheres in different clinical settings.
Reported Outcomes
Published studies report that polyvinyl alcohol microspheres are effective in reducing tumor size and improving symptoms in conditions like hepatocellular carcinoma and uterine fibroids. They have shown promise in enhancing the efficacy of transarterial chemoembolization by incorporating multifunctional agents.
Safety Profile
Reported complications include typical embolization-related risks such as post-embolization syndrome, which may involve pain and fever. No significant adverse events specific to polyvinyl alcohol microspheres were highlighted in the studies.
Evidence Limitations
The evidence is limited by the short duration of follow-up in some studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for polyvinyl alcohol embolic microspheres?
They are indicated for use in embolization procedures, such as treating liver tumors and uterine fibroids, by occluding blood vessels.
What outcomes have been reported in clinical studies?
Studies have reported effective tumor size reduction and symptom improvement in conditions like hepatocellular carcinoma and uterine fibroids.
What complications have been reported?
Safety data indicate common embolization-related complications such as post-embolization syndrome, with no significant device-specific 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.