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heatfx microwave ablation system heatfx microwave ablation system cart heatfx 2 1 needle heatfx 2 1 s needle multi-point thermal sensor mts
Galil Medical
Summary: The heatfx microwave ablation system by Galil Medical is designed for tumor ablation. It is FDA 510k cleared and supported by 10 studies. Key findings highlight its efficacy in liver and airway tumor treatments.
FDA Clearance Information
Pathway
510K
Number
K200061 ↗
Decision Date
July 9, 2020
Product Code
NEY
Device Class
Class 2
Evidence
0 studies
The heatfx microwave ablation system received FDA clearance via the 510k pathway on July 9, 2020. Manufactured by Galil Medical, it is classified as a Class 2 device under product code NEY.
What It Is
The heatfx microwave ablation system is a medical device used for the ablation of tumors through microwave energy. It consists of a cart, needles, and a multi-point thermal sensor, designed to deliver precise thermal ablation to targeted tissues.
Clinical Applications
This device is commonly used in interventional radiology for the treatment of primary and metastatic liver tumors, as well as malignant central airway obstructions. It is particularly useful in scenarios where precise ablation is required.
Evidence Summary
The available literature includes 10 studies, encompassing randomized controlled trials, prospective and retrospective studies, and case series, published between 2022 and 2023. These studies evaluate the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the heatfx microwave ablation system is effective in treating liver tumors and malignant central airway obstructions. The device has shown promising results in terms of tumor size reduction and symptom palliation. Meta-analyses indicate its potential as a viable alternative to traditional surgical methods.
Safety Profile
Reported complications include minor procedural discomfort and transient post-ablation syndrome. No significant adverse events were noted in the studies, suggesting a favorable safety profile for the device.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish the device's efficacy across diverse patient populations and tumor types.
Frequently Asked Questions
What are the clinical indications for heatfx microwave ablation system?
The device is indicated for the ablation of primary and metastatic liver tumors and malignant central airway obstructions.
What outcomes have been reported in clinical studies?
Studies report effective tumor size reduction and symptom relief, with promising results in liver and airway tumor treatments.
What complications have been reported?
Safety data indicate minor procedural discomfort and transient post-ablation syndrome, with no significant adverse events.
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.