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oncozene microspheres
Varian Medical Systems
Summary: Oncozene Microspheres are used for embolization in cancer treatment, primarily hepatocellular carcinoma. Key evidence includes studies on safety and efficacy in both clinical and animal models.
FDA Clearance Information
Pathway
510K
Number
K242794 ↗
Decision Date
October 16, 2024
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
Oncozene Microspheres received FDA clearance through the 510(k) pathway on October 16, 2024. Manufactured by Varian Medical Systems, they are classified as Class 2 under product code KRD.
What It Is
Oncozene Microspheres are embolic devices used in transcatheter arterial chemoembolization (TACE) procedures. They deliver chemotherapeutic agents directly to tumors, primarily for treating hepatocellular carcinoma.
Clinical Applications
Commonly used in the treatment of liver tumors, Oncozene Microspheres are employed in TACE to block blood flow to the tumor while delivering chemotherapy. This approach is often used for patients with unresectable liver cancer.
Evidence Summary
The literature includes four studies, ranging from 2020 to 2022, covering both clinical and preclinical research. Study types include retrospective cohort studies and animal model research.
Reported Outcomes
Published studies report that Oncozene Microspheres are effective in delivering chemotherapy to liver tumors, with evidence of tumor response and progression-free survival. Clinical studies have shown comparable outcomes to other embolic agents.
Safety Profile
Reported complications include typical embolization-related events such as post-embolization syndrome. Animal studies have investigated the safety profile, noting manageable toxicity levels.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term outcome data. Further research is needed to establish comprehensive safety and efficacy profiles across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Oncozene Microspheres?
Oncozene Microspheres are indicated for use in transcatheter arterial chemoembolization (TACE) procedures, primarily for treating hepatocellular carcinoma.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective tumor response and progression-free survival when using Oncozene Microspheres in TACE procedures.
What complications have been reported?
Safety data indicate complications such as post-embolization syndrome, which are common in embolization procedures.
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.