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microwave ablation antennas
Canyon Medical
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 510K
Number K241825 ↗
Decision Date September 20, 2024
Product Code NEY
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.
Clinical Applications
These antennas are commonly used in the treatment of liver tumors, including hepatocellular carcinoma, where precise ablation is required. They are often employed in minimally invasive procedures guided by imaging techniques.
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.
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.