Microthermx Microwave Ablation System Models Mtx-180 or Mtx
Bsd Medical
FDA Clearance Information
The MicroThermX Microwave Ablation System, manufactured by BSD Medical, received FDA clearance through the 510(k) pathway on August 13, 2010. It is classified as a Class II medical device.
What It Is
FDA-Cleared Indications
- Ablation of soft-tissue tumors using microwave energy.
- Use with compatible microwave ablation accessories and imaging guidance for targeting and treating tumor tissue.
Clinical Applications
- Image-guided microwave ablation of selected soft-tissue tumors.
- Percutaneous tumor ablation performed under CT or ultrasound guidance when the patient and tumor are appropriate candidates.
- Thermal destruction of tumor tissue as an alternative to surgical resection in selected cases.
Reported off-label uses
- Microwave ablation of selected liver tumors when the specific use, tumor characteristics, or treatment plan falls outside the device labeling.
- Microwave ablation of selected lung, kidney, or bone tumors when those applications are not specifically covered by the device labeling.
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 includes models such as the MTX-180 or MTX and requires compatible microwave antennas and accessories; available antenna sizes and configurations should be confirmed in the current labeling.
- Treatment is typically performed with CT or ultrasound guidance, depending on tumor location and visibility.
- Microwave ablation generates heat and requires attention to nearby organs, vessels, nerves, skin, and implanted devices.
- MRI compatibility should not be assumed. The generator, antenna, cables, and accessories require review of the current manufacturer labeling before MRI use or treatment in an MRI environment.
- Contraindications and precautions depend on tumor location, bleeding risk, infection, nearby critical structures, implanted devices, and the patient's overall condition.
Frequently Asked Questions
What is the MicroThermX Microwave Ablation System used for?
It is used for the ablation of soft tissue tumors using microwave energy to destroy tumor cells.
What specialties typically use this device?
Interventional radiologists and oncologists primarily use this device for tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, providing a treatment option for patients with inoperable or difficult-to-access tumors.