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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
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 ?
510(k)
Number ?
K200061 ↗
Decision Date ?
July 9, 2020
Product Code ?
NEY System, Ablation, Microwave And Accessories
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.
FDA-Cleared Indications
- Microwave ablation of tumors when used with the compatible heatfx microwave ablation system accessories.
- Treatment of selected primary or metastatic liver tumors.
- Treatment of selected malignant central airway obstructions.
Clinical Applications
- Percutaneous microwave ablation of selected liver tumors under image guidance.
- Treatment of primary liver malignancies, including selected hepatocellular carcinoma lesions.
- Treatment of metastatic tumors in the liver.
- Microwave ablation of selected malignant central airway lesions or obstructions.
- Thermal monitoring during ablation using the multi-point thermal sensor.
Reported off-label uses
- Microwave ablation of tumors in organs or tissues not specifically included in the device labeling may be reported in clinical practice, but this use is off-label and should be evaluated by the treating specialist.
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 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.
Practical Considerations
- The system includes a cart, microwave ablation needles, and a multi-point thermal sensor; the available needle and sensor configurations depend on the specific system components cleared for use.
- Procedures are generally performed with ultrasound, computed tomography, or another appropriate imaging method to guide needle placement and monitor the ablation zone.
- The device is intended for use by trained clinicians familiar with tumor ablation, image-guided needle placement, anesthesia or sedation, and management of thermal injury.
- MRI compatibility should be confirmed in the current device-specific labeling before use in or near an MRI environment; microwave ablation equipment and metallic accessories should not be assumed to be MRI safe.
- Potential contraindications and precautions include inability to safely access the target, uncorrected bleeding risk, active infection at the access site, and tumor location near critical structures unless adequate protection and monitoring are possible.
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.