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flex microwave ablation system and accessories
Neuwave Medical
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
510K
Number
K163118 ↗
Decision Date
March 9, 2017
Product Code
NEY
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.
Clinical Applications
Commonly used in the ablation of tumors in the liver, lung, and other soft tissues. It is particularly useful in cases where surgical resection is not feasible.
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.
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.