📊 Evidence-Based Reference

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 tissues. Key evidence highlights its efficacy and safety in various clinical settings.

FDA Clearance Information

Pathway 510K
Decision Date November 13, 2020
Product Code NEY
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.

Clinical Applications

Common clinical scenarios for the Neuwave Microwave Ablation System include the treatment of hepatocellular carcinoma and osteoid osteoma. It is used in both percutaneous and laparoscopic procedures.

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.

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)

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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 Microwave Ablation HCC China Study

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ClinicalTrials.gov

NOLA (NeuWave Observational Liver Ablation) Registry

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ClinicalTrials.gov

NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung

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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.

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