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neuwave microwave ablation system and accessories
Neuwave Medical
Summary: The Neuwave Microwave Ablation System is a device used for tumor ablation, primarily in liver and lung applications. Key evidence highlights its efficacy and safety in various clinical settings.
FDA Clearance Information
Pathway 510K
Number K231738 ↗
Decision Date November 16, 2023
Product Code NEY
Device Class Class 2
Evidence 5 studies
The Neuwave Microwave Ablation System, manufactured by Neuwave Medical, received FDA 510k clearance (K231738) on November 16, 2023. It is classified as a Class 2 medical device.
What It Is
The Neuwave Microwave Ablation System is designed for the ablation of soft tissue lesions. It uses microwave energy to generate heat, causing coagulative necrosis of the targeted tissue, and is intended for use in tumor ablation procedures.
Clinical Applications
Common clinical scenarios for the Neuwave system include the treatment of hepatocellular carcinoma and osteoid osteoma, as well as bronchoscopic ablation of lung tissue. It is often used in minimally invasive procedures.
Evidence Summary
The available literature includes 15 studies, comprising prospective evaluations, RCTs, and comparative studies, conducted between 2022 and 2026. These studies assess the device's efficacy, safety, and cost-effectiveness.
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 cases. Comparative studies indicate its efficacy is on par with other microwave systems.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile in both liver and lung applications. Safety assessments in animal models support its use in clinical settings.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for long-term follow-up studies. Further research is needed to explore its efficacy in diverse patient populations and to compare it with alternative ablation technologies.
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 lesions, including tumors in the liver and lung.
What outcomes have been reported in clinical studies?
Studies report effective tumor ablation with favorable outcomes in hepatocellular carcinoma and osteoid osteoma cases.
What complications have been reported?
Safety data indicate minimal adverse events, with a favorable safety profile in both liver and lung applications.
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.