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tri-loop microwave ablation probe
Vivant Medical
Summary: The tri-loop microwave ablation probe is a medical device used for the ablation of tumors. It is typically utilized by interventional radiologists and oncologists in hospital settings.
FDA Clearance Information
Pathway 510K
Number K032047 ↗
Decision Date August 6, 2003
Product Code GEI
Device Class Class 2
Evidence 0 studies
The tri-loop microwave ablation probe by Vivant Medical was cleared through the FDA 510k pathway on August 6, 2003. It is a Class 2 device under product code GEI.
What It Is
The tri-loop microwave ablation probe is a device designed to deliver microwave energy to ablate, or destroy, tumor tissues. It operates by generating heat through microwave energy, which induces cellular death in targeted tissues. This minimally invasive technique is often used as an alternative to surgical resection, particularly in patients who are not surgical candidates.
Clinical Applications
This device is commonly used in the treatment of liver, lung, and kidney tumors. It is particularly beneficial in interventional radiology and oncology settings, where it provides a minimally invasive option for tumor management. The probe is often used in patients with inoperable tumors or those who prefer a less invasive approach.
Indications for Use
The FDA indications for the tri-loop microwave ablation probe include the ablation of soft tissue tumors. It is suitable for patients with tumors that are difficult to access surgically or for those who are not ideal candidates for surgery.
Practical Considerations
The tri-loop design allows for precise targeting of the tumor, with typical probe sizes varying to accommodate different tumor sizes and locations. Compatibility with imaging modalities like CT or ultrasound is crucial for accurate placement and monitoring during the procedure.
Frequently Asked Questions
What is the tri-loop microwave ablation probe used for?
It is used for the ablation of soft tissue tumors, providing a minimally invasive treatment option.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, particularly in patients who are not candidates for surgical resection.
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.