đź“‹ FDA Reference
oncozene microspheres 40um 2ml oncozene microspheres 75um 2ml oncozene microspheres 100um 2ml oncozene microsphere
Celonova Biosciences
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 510K
Number K130307 ↗
Decision Date March 4, 2013
Product Code KRD
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.
Clinical Applications
These microspheres are commonly used in interventional oncology, particularly for treating liver tumors such as hepatocellular carcinoma or metastatic liver disease. They are deployed in a minimally invasive procedure by interventional radiologists, often in a hospital or outpatient setting. The device is suitable for patients who are not candidates for surgery or other systemic therapies.
Indications for Use
The FDA-cleared indications for Oncozene Microspheres involve their use in embolization procedures to treat hypervascularized tumors. This means they are intended for patients with tumors that have a rich blood supply, which can be effectively targeted by blocking the feeding vessels.
Practical Considerations
Oncozene Microspheres are available in sizes of 40µm, 75µm, and 100µm, allowing for tailored treatment based on vessel size. They are compatible with standard microcatheters used in embolization procedures. Clinicians should consider the size of the target vessels and the nature of the tumor when selecting the appropriate microsphere size.
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.