Microwave Ablation Device
Nanjing Dewen Medical Technology Co., Ltd.
FDA Clearance Information
FDA-Cleared Indications
- For coagulation and ablation of tissue during percutaneous, laparoscopic, or open surgical procedures when the device is used according to its FDA-cleared labeling.
- For use with compatible microwave ablation accessories and an approved microwave generator to deliver controlled thermal energy to targeted tissue.
Clinical Applications
- Image-guided percutaneous ablation of selected liver tumors.
- Image-guided percutaneous ablation of selected kidney tumors.
- Laparoscopic or open surgical tissue ablation when used with compatible equipment and according to the device labeling.
- Thermal coagulation or ablation of targeted soft tissue under the direction of an appropriately trained physician.
Reported off-label uses
- Ablation of selected lung tumors.
- Ablation of adrenal or bone tumors.
- Palliative ablation of painful metastatic tumors.
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 may include microwave generators, antennas or probes, cables, grounding or dispersive components when specified, and other accessories; compatibility should be confirmed before use.
- Probe diameter, active-tip length, shaft length, and antenna configuration vary by model and affect the ablation zone and access route.
- Treatment is usually performed with ultrasound, CT, or another appropriate imaging method, using local anesthesia with moderate sedation or general anesthesia depending on the procedure.
- MRI compatibility is model-specific. Do not bring the generator, cables, or probes into the MRI environment unless the complete system is specifically labeled for that use.
- Contraindications and precautions depend on the target organ, bleeding risk, infection, nearby critical structures, implanted devices, and the manufacturer's instructions for use.
Procedures that use this device
Frequently Asked Questions
What is a microwave ablation device used for?
It delivers microwave energy through a probe to heat and destroy targeted tissue. In the procedures listed for this device category, it is used mainly for selected liver and kidney tumors under imaging guidance.
Is a microwave ablation device MRI safe?
MRI safety is specific to the generator, probe, cables, and accessories. Do not use or bring the system into an MRI suite unless the exact components are labeled MR Safe or MR Conditional and all conditions are met.
What sizes are microwave ablation probes?
Probe diameter, shaft length, active-tip length, and antenna design vary by model. The treating physician selects the configuration based on the target size, location, access route, and desired ablation zone.
How long does a microwave ablation device last?
The generator is reusable and requires maintenance according to the manufacturer's schedule. Many probes and accessories are single-use and must be discarded after the procedure; the labeling determines whether a component can be reused.
How much does microwave ablation cost?
Cost varies by hospital, anesthesia, imaging, disposable probe, physician fees, and insurance coverage. Patients should request an estimate from the treating facility and confirm coverage with their insurer.