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Easi-Vue R Embolic Microspheres System
Product: Easi-Vue embolic microspheres System — all models and sizes
Summary: The easi-vue r embolic microspheres system is a medical device used for embolization procedures. It is primarily used in the treatment of hepatic malignancies. Key evidence highlights its application in transarterial radioembolization (TARE) with promising safety and efficacy profiles.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K234123 ↗
Decision Date ?
February 13, 2024
Product Code ?
KRD Device, Vascular, For Promoting Embolization
Device Class ?
Class 2
Evidence ?
0 studies
The easi-vue r embolic microspheres system was cleared by the FDA through the 510(k) pathway on February 13, 2024. It is manufactured by Abk Biomedical and classified as a Class 2 device.
What It Is
The easi-vue r embolic microspheres system is designed for embolization procedures, delivering microspheres to occlude blood vessels. It is intended for use in treating hepatic malignancies, leveraging its ability to target and deliver therapeutic agents directly to tumors.
FDA-Cleared Indications
- Embolization of selected blood vessels using microspheres delivered through a catheter.
- Use in the treatment of hepatic malignancies, according to the device's FDA-cleared labeling.
Clinical Applications
- Transarterial embolization of blood vessels supplying liver tumors, when performed within the FDA-cleared indication.
- Catheter-directed delivery of embolic microspheres to reduce or stop blood flow to selected hepatic malignancies.
Reported off-label uses
- Prostatic artery embolization for benign prostatic hyperplasia has been described for embolic microsphere devices, but it should not be assumed to be an FDA-cleared indication for this specific product.
- Embolization of other tumors or vascular conditions may be reported for this device category, but use outside the product labeling is off-label and requires clinician judgment.
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 available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, published between 2023 and 2025. These studies explore the safety and efficacy of embolization procedures using this device.
Reported Outcomes
Published studies report that the easi-vue r embolic microspheres system is effective in delivering targeted embolization, with outcomes showing improved control of hepatic malignancies. Studies highlight its role in radiation segmentectomy and prostatic artery embolization, demonstrating positive clinical outcomes.
Safety Profile
Reported complications include radiation pneumonitis in radioembolization procedures and potential adverse events related to embolization. Safety profiles from studies indicate a manageable risk profile with appropriate patient selection and procedural planning.
Evidence Limitations
Current evidence is limited by the relatively small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term efficacy and safety, as well as to explore its use in other clinical settings.
Practical Considerations
- The appropriate microsphere size and embolization endpoint depend on the target vessel, tumor vascularity, desired level of occlusion, and angiographic findings.
- The device must be used with compatible catheter and delivery-system components according to the manufacturer's instructions for use.
- Microspheres require careful preparation and suspension before delivery; avoid aggregation, excessive concentration, or injection against significant resistance.
- Contraindications and precautions include non-target embolization risk, uncorrectable coagulopathy, severe vascular tortuosity or spasm, and inability to safely catheterize the target vessel.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; do not assume MRI compatibility without checking the device-specific instructions for use.
Frequently Asked Questions
What are the clinical indications for easi-vue r embolic microspheres system?
The device is indicated for embolization procedures, particularly in the treatment of hepatic malignancies and benign prostatic hyperplasia.
What outcomes have been reported in clinical studies?
Studies report effective embolization with improved control of liver tumors and positive outcomes in prostatic artery embolization.
What complications have been reported?
Safety data indicate complications such as radiation pneumonitis and other embolization-related adverse events, which are generally manageable.
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.