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Avecure Bt Microwave Ablation System
Summary: The Avecure BT Microwave Ablation System is a medical device used for the ablation of tumors. It is primarily utilized by interventional radiologists and oncologists to treat patients with certain types of tumors.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K192406 ↗
Decision Date ?
November 25, 2020
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The Avecure BT Microwave Ablation System was cleared through the FDA 510k pathway on November 25, 2020. Manufactured by Medwaves, it is classified as a Class 2 device under product code NEY.
What It Is
The Avecure BT Microwave Ablation System is a device that uses microwave energy to generate heat, which is then applied to tissue to destroy tumor cells. It is designed for precise targeting and efficient ablation of tumors, offering a minimally invasive option for patients. The system typically consists of a microwave generator, applicator, and cooling system to ensure controlled and effective treatment.
FDA-Cleared Indications
- Ablation of soft-tissue tumors that are amenable to microwave ablation.
Clinical Applications
- Image-guided microwave ablation of selected soft-tissue tumors.
- Percutaneous, laparoscopic, or surgical placement of a microwave ablation applicator when clinically appropriate.
- Thermal destruction of targeted tumor tissue as an alternative or complement to surgical treatment in appropriately selected patients.
Practical Considerations
- Treatment is typically performed with ultrasound, computed tomography, or another suitable imaging method to guide applicator placement and monitor the ablation zone.
- The system generally includes a microwave generator, ablation applicator, and a cooling system; available applicator sizes and configurations should be confirmed in the current manufacturer labeling.
- Patient selection depends on tumor size, location, tissue type, proximity to critical structures, bleeding risk, infection risk, and the availability of a safe applicator path.
- Microwave ablation systems are not automatically MRI safe. The generator, applicator, cables, and other components should be used in MRI only when their current labeling specifically permits it.
- The procedure may involve local anesthesia with moderate sedation or general anesthesia, depending on the tumor location, approach, and patient factors.
Frequently Asked Questions
What is the Avecure BT Microwave Ablation System used for?
It is used for the ablation of tumors in soft tissues, such as the liver, lung, and kidney.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, providing a minimally invasive treatment option.
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.