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easi-vue r embolic microspheres system
Abk Biomedical
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 510K
Number K234123 ↗
Decision Date February 13, 2024
Product Code KRD
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.
Clinical Applications
Common clinical scenarios for this device include transarterial radioembolization (TARE) for liver tumors and prostatic artery embolization for benign prostatic hyperplasia. It is used in interventional radiology to manage vascular supply to tumors or hyperplastic tissues.
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.
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.