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NeuWave Microwave Ablation System and Accessories
Summary: The Neuwave Microwave Ablation System is a device used for tumor ablation. It is primarily used in the treatment of liver tumors and other solid tumors. Key evidence highlights its safety and efficacy in various clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K220472 ↗
Decision Date ?
August 11, 2022
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
5 studies
The Neuwave Microwave Ablation System was cleared by the FDA through the 510(k) pathway on August 11, 2022. It is manufactured by Neuwave Medical and is classified as a Class 2 medical device.
What It Is
The Neuwave Microwave Ablation System is a medical device designed for the ablation of soft tissue tumors using microwave energy. It is intended for use in clinical settings to treat tumors in organs such as the liver and lungs.
FDA-Cleared Indications
- Ablation of soft-tissue tumors using microwave energy.
- Use in clinical settings for tumor ablation, including tumors in the liver and lungs, according to the device labeling.
Clinical Applications
- Percutaneous microwave ablation of selected liver tumors.
- Microwave ablation of selected lung tumors.
- Tumor ablation when surgical resection is not feasible or is not selected as the treatment approach.
- Image-guided ablation performed by qualified clinicians in interventional radiology or oncology settings.
Reported off-label uses
- Microwave ablation of selected kidney tumors has been described for this device category, but use must be confirmed against the specific device labeling and institutional policy.
- Microwave ablation of selected adrenal, bone, or soft-tissue tumors has been reported for this device category, but these applications may be off-label.
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.
Evidence Summary
The available literature includes 15 studies, comprising prospective and comparative studies, with publication years ranging from 2022 to 2026. These studies evaluate the safety, efficacy, and cost-effectiveness of the device in various clinical applications.
Reported Outcomes
Published studies report that the Neuwave Microwave Ablation System is effective in creating ablation zones in liver tumors, with comparable efficacy to other microwave systems. It has been shown to be a viable alternative to radiofrequency ablation in certain clinical settings.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile. The device has been assessed for safety in both human and animal models, showing low incidence of complications.
Evidence Limitations
The evidence is limited by the small sample sizes and the need for longer-term follow-up studies to fully assess the long-term efficacy and safety. Further research is needed to compare the device with other ablation technologies in diverse patient populations.
Practical Considerations
- The system includes a microwave generator and compatible ablation antennas or accessories; antenna sizes, shaft lengths, active-tip lengths, and compatibility depend on the specific model and labeling.
- Placement is typically performed with ultrasound, computed tomography, or another appropriate imaging modality, with attention to nearby bile ducts, bowel, major vessels, nerves, and other organs.
- MRI compatibility is accessory-specific. Do not assume that the generator, cables, antennas, or other components are safe in the MRI environment; follow the manufacturer’s MRI labeling.
- Contraindications and precautions depend on tumor location, bleeding risk, infection, implanted devices, and the patient’s overall condition. Review the current instructions for use before treatment.
- Microwave ablation may be performed with local anesthesia and moderate sedation or with general anesthesia, depending on the tumor, access route, and patient needs.
Linked Studies (5)
PubMed • 2023
Comparative Study of Ablation Zone of EMPRINT HP Microwave Device with Contemporary 2.4 GHz Microwave Devices in an Ex Vivo Porcine Liver Model.
Diagnostics (Basel, Switzerland)
View Source →PubMed • 2023
Device safety assessment of bronchoscopic microwave ablation of normal swine peripheral lung using robotic-assisted bronchoscopy.
International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung
View Source →Frequently Asked Questions
What are the clinical indications for Neuwave Microwave Ablation System?
The device is indicated for the ablation of soft tissue tumors, including hepatocellular carcinoma and other solid tumors where surgical options are limited.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective tumor ablation with the Neuwave system, demonstrating comparable efficacy to other microwave ablation systems and radiofrequency ablation.
What complications have been reported?
Safety data from studies indicate minimal complications, with a favorable safety profile observed in both human and animal studies.
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.