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NeuWave Microwave Ablation System and Accessories
Product: NeuWave — all models and sizes
Summary: The Neuwave Microwave Ablation System is a device used for tumor ablation, primarily in liver and lung tissues. Key evidence highlights its efficacy and safety in various clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K200081 ↗
Decision Date ?
November 13, 2020
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 November 13, 2020. It is manufactured by Neuwave Medical and classified as a Class 2 device.
What It Is
The Neuwave Microwave Ablation System is designed for the ablation of soft tissue tumors using microwave energy. It is intended for use in minimally invasive procedures to treat tumors in organs such as the liver and lungs.
FDA-Cleared Indications
- Ablation of soft-tissue tumors using microwave energy.
- Use in percutaneous and laparoscopic procedures for tumor ablation.
- Use with compatible microwave ablation accessories identified in the cleared device system.
Clinical Applications
- Percutaneous microwave ablation of selected soft-tissue tumors under imaging guidance.
- Laparoscopic microwave ablation of selected soft-tissue tumors.
- Microwave ablation of tumors in organs such as the liver and lung when the procedure is clinically appropriate.
Reported off-label uses
- Microwave ablation of osteoid osteoma has been described in clinical practice, but the specific indication should be confirmed against the current device labeling and local regulatory requirements.
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 evaluations, RCTs, and comparative studies. The studies span from 2022 to 2026, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the Neuwave Microwave Ablation System is effective in achieving tumor ablation with favorable outcomes in hepatocellular carcinoma and osteoid osteoma. Comparative studies indicate its efficacy is comparable to other microwave systems.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile. Specific safety assessments in swine models show the device's safe application in peripheral lung tissue.
Evidence Limitations
Current evidence is limited by the lack of long-term follow-up data and the need for larger, multicenter trials to confirm findings. Further research is needed to explore its efficacy in diverse patient populations.
Practical Considerations
- The system requires compatible microwave antennas, cables, generators and other accessories; available antenna lengths, active-tip sizes and configurations depend on the cleared system components.
- Procedures are typically performed with ultrasound, computed tomography or laparoscopic visualization to position the antenna and monitor the ablation zone.
- The antenna is introduced through the skin or laparoscopic access under local anesthesia with moderate sedation, monitored anesthesia care or general anesthesia, depending on the procedure.
- MRI compatibility should not be assumed. The generator, antenna, cables and accessories must be checked individually against the current manufacturer labeling before use in or near an MRI scanner.
- Important risks include bleeding, infection, injury to adjacent organs, thermal damage, incomplete ablation and tumor recurrence. Contraindications and precautions depend on tumor location, patient condition, coagulation status and the current instructions for use.
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 osteoid osteoma.
What outcomes have been reported in clinical studies?
Studies report effective tumor ablation with comparable efficacy to other microwave systems, particularly in liver and lung applications.
What complications have been reported?
Safety data indicate minimal adverse events, with specific studies showing safe application in lung tissue using robotic-assisted bronchoscopy.
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.