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Oncozene Microspheres
Product: ONCOZENE Oncozene — all models and sizes
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 ?
510(k)
Number ?
K242794 ↗
Decision Date ?
October 16, 2024
Product Code ?
KRD Device, Vascular, For Promoting Embolization
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.
FDA-Cleared Indications
- Embolization of blood vessels when vascular occlusion is indicated.
- Use as an embolic device in transcatheter arterial chemoembolization procedures for appropriately selected tumors.
- Use in patients for whom the treating physician determines that arterial embolization is clinically appropriate.
Clinical Applications
- Transcatheter arterial chemoembolization for selected hepatocellular carcinoma.
- Embolization of arteries supplying a liver tumor while chemotherapy is delivered through the catheter.
- Treatment of selected unresectable liver tumors when arterial embolization is part of the treatment plan.
Reported off-label uses
- Embolization of selected metastatic liver tumors.
- Transarterial embolization or radioembolization-related applications for other solid tumors, depending on the specific device labeling and treatment plan.
- Embolization of selected tumors outside the liver, as reported for embolic microspheres generally.
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 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.
Practical Considerations
- Microsphere size and concentration should be selected according to tumor vascularity, target-vessel anatomy, desired embolization endpoint, and the device instructions for use.
- The microspheres are delivered through a compatible angiographic catheter under fluoroscopic or other x-ray imaging guidance; catheter size and injection technique must be compatible with the product.
- Careful angiography is required to identify vessels supplying non-target organs and to reduce the risk of non-target embolization.
- Contraindications and precautions may include uncorrectable coagulopathy, severe vessel tortuosity or spasm, significant arteriovenous shunting, infection, or inability to safely catheterize the target vessel.
- MRI compatibility and artifact information should be confirmed in the current manufacturer labeling. Embolization is intended to be permanent or long-lasting, so future procedures may be affected by the treated vessels.
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.