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Certus 140 Microwave Ablation System and Accessories Model Certus 140
Summary: The Certus 140 Microwave Ablation System is a medical device used for the ablation of tumors, particularly in the liver. It is primarily used by interventional radiologists and oncologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K100744 ↗
Decision Date ?
October 22, 2010
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The Certus 140 Microwave Ablation System by Neuwave Medical was cleared through the FDA 510k pathway on October 22, 2010. It is classified as a Class 2 device under product code NEY.
What It Is
The Certus 140 Microwave Ablation System is a high-power microwave ablation device designed to treat tumors by using microwave energy to generate heat and destroy cancerous tissue. It features a gas-cooled system and is capable of supporting multiple antennas, allowing for precise targeting and effective treatment of tumors. This system is particularly useful in treating hepatocellular carcinoma and other solid tumors.
FDA-Cleared Indications
- Ablation of soft-tissue tumors.
- Use of microwave energy to thermally ablate targeted tumor tissue under appropriate clinical imaging guidance.
Clinical Applications
- Percutaneous microwave ablation of selected liver tumors, including hepatocellular carcinoma.
- Ablation of soft-tissue tumors when thermal destruction is clinically appropriate.
- Treatment of selected tumors in patients who are not candidates for surgical resection.
- Use with compatible microwave antennas selected according to tumor size, location and treatment plan.
Reported off-label uses
- Microwave ablation of selected tumors outside the device's labeled indication may be reported in clinical practice, but use depends on the specific device labeling, local regulations, available evidence and clinician judgment.
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
- The system uses gas-cooled microwave antennas and may support simultaneous use of multiple antennas; compatible antenna models and sizes must be confirmed in the current device labeling.
- Antenna placement is typically performed with ultrasound, computed tomography or another suitable imaging method to target the tumor and limit injury to nearby organs.
- The procedure requires planning for the tumor's size, shape, location and proximity to bile ducts, blood vessels, bowel and other heat-sensitive structures.
- This is not an MRI-compatible implant or an MRI scanner; MRI safety and conditional-use information must be checked for any accessories or implanted materials used during treatment.
- Contraindications and precautions depend on the patient's anatomy, tumor location, infection or bleeding risk, anesthesia status and the current manufacturer's instructions for use.
Related Literature
The linked study evaluated the use of a gas-cooled microwave ablation system in treating 107 hepatocellular carcinoma tumors. The study found that the device was effective in achieving tumor ablation with minimal complications. However, as a retrospective study, it may have limitations in terms of selection bias and lack of randomization. Further research is needed to confirm these findings in larger, controlled trials.
Frequently Asked Questions
What is the Certus 140 Microwave Ablation System used for?
It is used for the ablation of tumors, particularly in the liver, by using microwave energy to destroy cancerous tissue.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in hospital settings for tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, such as those found in the liver, particularly hepatocellular carcinoma.
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.