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easi-vue embolic microspheres system
Abk Biomedical
Summary: The easi-vue embolic microspheres system is a device used for embolization procedures, primarily in oncology. It is FDA-cleared and supported by multiple studies, though specific outcomes and safety data are limited in the provided evidence.
FDA Clearance Information
Pathway
510K
Number
K220567 ↗
Decision Date
September 7, 2022
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The easi-vue embolic microspheres system was cleared by the FDA via the 510(k) pathway on September 7, 2022. It is manufactured by Abk Biomedical and classified as a Class 2 device.
What It Is
The easi-vue embolic microspheres system is designed for embolization, a procedure that blocks blood flow to tumors or other abnormal tissue. It is intended for use in interventional radiology, particularly in oncology settings.
Clinical Applications
Commonly used in transcatheter arterial chemoembolization (TACE) for treating inoperable liver cancers, the device aids in delivering therapeutic agents directly to the tumor site, minimizing systemic exposure.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and case series, published between 2023 and 2025. These studies explore the use of microspheres in embolization and related therapies.
Reported Outcomes
Published studies report varied outcomes with the use of embolic microspheres in cancer treatment, particularly in enhancing anti-tumor immunity in hepatocellular carcinoma. However, specific efficacy data from the provided studies is limited.
Safety Profile
Reported complications include general risks associated with embolization procedures, but specific adverse events related to the easi-vue system are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the easi-vue system. Further research is needed to establish comprehensive efficacy and safety profiles, as well as to explore long-term outcomes.
Frequently Asked Questions
What are the clinical indications for easi-vue embolic microspheres system?
The device is indicated for use in embolization procedures, particularly in the treatment of inoperable liver cancers through transcatheter arterial chemoembolization (TACE).
What outcomes have been reported in clinical studies?
Studies report enhanced anti-tumor immunity in hepatocellular carcinoma, but specific outcome data for the easi-vue system is limited in the provided evidence.
What complications have been reported?
Safety data specific to the easi-vue system is not detailed in the provided studies, though general risks of embolization procedures are acknowledged.
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.