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certus 140 microwave ablation system and accessories model certus 140
Neuwave Medical
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 510K
Number K100744 ↗
Decision Date October 22, 2010
Product Code NEY
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.
Clinical Applications
This device is commonly used in interventional radiology and oncology settings for the treatment of liver tumors, such as hepatocellular carcinoma. It is suitable for percutaneous procedures where minimally invasive techniques are preferred. Patients with inoperable tumors or those who are not candidates for surgical resection often benefit from this treatment modality. The system's ability to use multiple antennas simultaneously makes it effective for larger or multiple tumors.
Indications for Use
The FDA indications for the Certus 140 include the ablation of soft tissue tumors. It is specifically indicated for patients with liver cancer, such as hepatocellular carcinoma, where traditional surgical options are not feasible.
Practical Considerations
The Certus 140 system is compatible with various antenna sizes, allowing for flexibility in treating different tumor sizes and locations. Clinicians should be familiar with the device's setup and cooling system to ensure optimal performance. Proper placement of the antennas is crucial for effective ablation and minimizing damage to surrounding tissues.
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.