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hrspheres narrow-size embolic microspheres
Suzhou Hengrui Hongyuan Medical
Summary: hrspheres narrow-size embolic microspheres are used for embolization procedures. They are FDA-cleared and supported by 10 studies. Key findings highlight their efficacy in targeted embolization.
FDA Clearance Information
Pathway 510K
Number K210562 ↗
Decision Date October 1, 2021
Product Code KRD
Device Class Class 2
Evidence 0 studies
The hrspheres narrow-size embolic microspheres were cleared by the FDA via the 510(k) pathway on October 1, 2021. Manufactured by Suzhou Hengrui Hongyuan Medical, they are classified as Class 2 devices.
What It Is
hrspheres narrow-size embolic microspheres are designed for use in embolization procedures to occlude blood vessels. They are intended for treating hypervascular tumors, hemorrhage, and vascular abnormalities.
Clinical Applications
Commonly used in transcatheter arterial embolization (TAE) and transcatheter arterial chemoembolization (TACE) for conditions like hepatocellular carcinoma and other hypervascular tumors.
Evidence Summary
The literature includes 10 studies, with types ranging from RCTs to case series, published between 2021 and 2025. These studies evaluate the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that hrspheres microspheres effectively occlude target vessels, improving outcomes in embolization procedures. They demonstrate enhanced embolization efficacy and controlled delivery to target sites.
Safety Profile
Reported complications include non-target delivery and transient arterial occlusion. However, the device's degradability allows for restoration of blood flow, potentially reducing long-term adverse events.
Evidence Limitations
Evidence gaps include the need for more large-scale RCTs to confirm long-term safety and efficacy. Some studies lack detailed safety data, and further research is needed to optimize device morphology and mechanical properties.
Frequently Asked Questions
What are the clinical indications for hrspheres narrow-size embolic microspheres?
They are indicated for embolization procedures in treating hypervascular tumors, hemorrhage, and vascular abnormalities.
What outcomes have been reported in clinical studies?
Studies report effective vessel occlusion and improved embolization outcomes, with enhanced delivery to target sites.
What complications have been reported?
Safety data indicate non-target delivery and transient occlusion, with potential for blood flow restoration due to device degradability.
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.