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Oncozene Microspheres 40um 2ml Oncozene Microspheres 75um 2ml Oncozene Microspheres 100um 2ml Oncozene Microsphere
Summary: Oncozene Microspheres are embolization devices used to block blood flow to tumors. They are primarily used by interventional radiologists in oncology settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K130307 ↗
Decision Date ?
March 4, 2013
Product Code ?
KRD Device, Vascular, For Promoting Embolization
Device Class ?
Class 2
Evidence ?
0 studies
The Oncozene Microspheres by Celonova Biosciences were cleared through the FDA 510(k) pathway on March 4, 2013. They are classified as Class 2 medical devices.
What It Is
Oncozene Microspheres are small, spherical embolic agents designed to occlude blood vessels. They are used in transarterial embolization procedures to restrict blood supply to tumors, thereby inhibiting their growth. The microspheres come in various sizes, allowing for precise targeting of different vessel calibers.
FDA-Cleared Indications
- Embolization of hypervascular tumors.
- Transcatheter delivery through a vascular catheter to occlude vessels supplying a target tumor.
- Use of 40, 75, or 100 micrometer microspheres selected according to the target vascular anatomy and treatment plan.
Clinical Applications
- Catheter-based embolization of tumors with a rich blood supply.
- Transarterial embolization performed by an interventional radiologist.
- Targeted occlusion of tumor-feeding arteries when reducing tumor blood flow is part of the treatment plan.
Reported off-label uses
- Embolization of selected non-tumor vascular conditions may be reported in clinical practice for microspheres of this type, but use outside the device labeling should be determined by the treating physician.
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.
Practical Considerations
- Available sizes include 40 micrometers in a 2 mL presentation, 75 micrometers in a 2 mL presentation, and 100 micrometers in a 2 mL presentation.
- The treating physician selects particle size based on tumor-feeding vessel size, desired embolic distribution, and angiographic findings.
- The microspheres are delivered through a catheter or microcatheter under fluoroscopic imaging; compatibility should be confirmed with the selected delivery system.
- As an embolic device, it may cause unintended vessel occlusion, non-target embolization, ischemia, pain, or tissue injury. Contraindications and precautions should be reviewed in the current manufacturer labeling.
- MRI safety and conditions should be confirmed in the current device labeling. The embolic material should not be assumed to be MRI safe without that information.
Frequently Asked Questions
What is Oncozene Microspheres used for?
Oncozene Microspheres are used for embolization to block blood flow to tumors, particularly in the liver.
What specialties typically use this device?
Interventional radiologists primarily use this device in oncology settings.
What are the FDA-cleared indications?
The device is indicated for embolization of hypervascularized tumors, effectively blocking their blood supply.
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.