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Microwave Ablation Antennas
Product: Microwave Ablation Antennas — all models and sizes
Summary: Microwave ablation antennas by Canyon Medical are used for tumor ablation. FDA-cleared via 510k pathway. Key evidence highlights enhanced cooling systems for improved ablation zones.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K241825 ↗
Decision Date ?
September 20, 2024
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The microwave ablation antennas by Canyon Medical received FDA clearance through the 510k pathway on September 20, 2024. They are classified as Class 2 medical devices.
What It Is
Microwave ablation antennas are devices used to deliver microwave energy to ablate tumor tissues. They are designed to create controlled thermal lesions in targeted areas, primarily for oncological applications.
FDA-Cleared Indications
- Used to deliver microwave energy for thermal ablation of targeted tissue.
- Indicated for use with compatible microwave ablation equipment and accessories as specified in the cleared labeling.
- Classified by FDA as a Class II microwave ablation system and accessories device under product code NEY.
Clinical Applications
- Percutaneous image-guided microwave ablation of selected tumors when the procedure is within the device labeling.
- Microwave ablation procedures involving targeted liver lesions, when performed according to the cleared system instructions.
- Use during minimally invasive oncology procedures with imaging guidance and compatible ablation equipment.
Reported off-label uses
- Microwave ablation of selected renal tumors in clinical practice.
- Microwave ablation of selected lung tumors in clinical practice.
- Microwave ablation of selected bone or soft-tissue tumors in specialized oncology practice.
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 10 studies, ranging from 2014 to 2024, covering various aspects of microwave ablation. Study types include RCTs, prospective, retrospective, and case series.
Reported Outcomes
Published studies report that the use of enhanced cooling systems in microwave ablation antennas results in more spherical ablation zones. The performance of these devices is influenced by factors such as hepatic vessel flow and perfusion, which can affect ablation volumes.
Safety Profile
Reported complications include potential structural and functional integrity issues with repeated use and resterilization of the antennas. No specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Practical Considerations
- Antenna dimensions, active-tip length, shaft configuration, and cooling design vary by model; clinicians should select the size and tip length for the target lesion and access route.
- The antenna must be used with the specified compatible microwave generator, cables, cooling system, and accessories.
- Procedures are generally performed with ultrasound, CT, or another appropriate imaging modality, using sterile technique and planned thermal-protection measures when nearby organs are at risk.
- MRI safety and conditional-use status are model-specific and should be confirmed in the current manufacturer labeling; do not assume the antenna is safe in the MR environment.
- Contraindications, warnings, and precautions may include inability to safely access the target, uncorrected bleeding risk, infection along the planned access route, and proximity to critical structures.
Frequently Asked Questions
What are the clinical indications for microwave ablation antennas?
Microwave ablation antennas are indicated for the ablation of tumors, particularly in the liver, such as hepatocellular carcinoma.
What outcomes have been reported in clinical studies?
Studies have shown that enhanced cooling systems improve the sphericity of ablation zones, and factors like perfusion can impact ablation performance.
What complications have been reported?
Safety data indicate potential issues with the structural integrity of antennas after repeated use and resterilization, but specific adverse events were not detailed.
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.