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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 ?
510(k)
Number ?
K210562 ↗
Decision Date ?
October 1, 2021
Product Code ?
KRD Device, Vascular, For Promoting Embolization
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.
FDA-Cleared Indications
- Embolization of blood vessels to promote occlusion.
- Use in transcatheter embolization procedures for hypervascular tumors.
- Use in transcatheter embolization procedures for hemorrhage.
- Use in transcatheter embolization procedures for vascular abnormalities.
Clinical Applications
- Transcatheter arterial embolization for selected hypervascular tumors.
- Transcatheter arterial chemoembolization for hepatocellular carcinoma when used with an appropriate chemotherapy regimen.
- Embolization to control bleeding from selected vascular territories.
- Embolization of selected vascular abnormalities requiring intentional vessel occlusion.
Reported off-label uses
- Embolization of symptomatic uterine fibroids.
- Preoperative embolization of selected hypervascular tumors.
- Embolization for selected noncancerous hypervascular conditions.
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 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.
Practical Considerations
- The appropriate microsphere size depends on the target vessel, blood-flow pattern, desired level of occlusion, and clinical objective; size selection should follow the product labeling and operator judgment.
- The microspheres are delivered through a compatible angiographic catheter under fluoroscopic imaging. Catheter compatibility and the minimum recommended inner diameter should be confirmed before use.
- The particles should be prepared and handled according to the manufacturer’s instructions to reduce aggregation and prevent unintended delivery or catheter blockage.
- Patients with an uncorrectable bleeding disorder, severe vascular access limitations, or a contraindication to angiography or contrast may not be suitable; patient-specific contraindications are defined by the labeling and clinical assessment.
- MRI safety should be verified from the current product labeling. Embolic microspheres are generally nonmetallic, but the catheter, delivery materials, and any other implanted devices must also be assessed.
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.