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Flex Microwave Ablation System and Accessories
Product: NeuWave — all models and sizes
Summary: The Flex Microwave Ablation System by Neuwave Medical is used for tumor ablation. Key evidence highlights its safety in bronchoscopic applications in animal models.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K163118 ↗
Decision Date ?
March 9, 2017
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The Flex Microwave Ablation System was cleared by the FDA via the 510k pathway on March 9, 2017. It is manufactured by Neuwave Medical and classified as a Class 2 device.
What It Is
The Flex Microwave Ablation System is a medical device designed for the ablation of soft tissue tumors using microwave energy. It is intended for use in minimally invasive procedures to destroy tumor cells.
FDA-Cleared Indications
- Ablation of soft-tissue tumors using microwave energy.
- Use with compatible microwave ablation accessories during minimally invasive tumor-ablation procedures.
Clinical Applications
- Percutaneous microwave ablation of selected soft-tissue tumors.
- Image-guided ablation when surgical removal is not feasible or is not selected.
- Treatment of appropriately selected tumors in organs such as the liver and lung, when consistent with the device labeling and clinical judgment.
Reported off-label uses
- Bronchoscopic microwave ablation approaches have been studied for selected lung lesions, including in preclinical models; this should not be interpreted as a general FDA-cleared indication.
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 literature includes 14 studies, with a mix of RCTs, prospective, and retrospective designs, spanning from 2009 to 2023. These studies evaluate the device's safety and efficacy in various clinical settings.
Reported Outcomes
Published studies report the Flex Microwave Ablation System as effective in achieving tumor ablation with minimal invasiveness. The device has shown promising results in maintaining patency in biliary obstructions and effective ablation in lung models.
Safety Profile
Reported complications include minimal adverse events in animal models, with no significant safety concerns noted in the studies reviewed. The device is generally considered safe for clinical use.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to establish the device's efficacy in diverse patient populations and clinical scenarios.
Practical Considerations
- The system includes microwave ablation equipment and compatible accessories; probe or antenna selection depends on the target, approach and treatment plan.
- Procedures are generally performed with imaging guidance, such as ultrasound, CT or another appropriate modality, and may require local anesthesia, moderate sedation or general anesthesia.
- The device is not automatically considered MRI safe. MRI compatibility must be confirmed for each system component and accessory before use in or near the MR environment.
- Contraindications and precautions depend on the target organ, tumor location, bleeding risk, infection risk, nearby vessels or ducts, and the specific product labeling.
- The system is intended for trained clinicians; accessory compatibility, sterile handling, grounding or generator requirements, and treatment settings must follow the manufacturer’s instructions for use.
Frequently Asked Questions
What are the clinical indications for Flex Microwave Ablation System?
The device is indicated for the ablation of soft tissue tumors, particularly in the liver and lung, where surgical options are limited.
What outcomes have been reported in clinical studies?
Studies report effective tumor ablation and maintenance of biliary patency with minimal invasiveness.
What complications have been reported?
Safety data from evidence indicate minimal adverse events, with no significant complications reported in the reviewed 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.