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ablatepal radiofrequency ablation system
Compal Electronics
Summary: The ablatepal radiofrequency ablation system is designed for tumor ablation, particularly in lung and thyroid applications. Key evidence highlights its efficacy in reducing tumor size with a favorable safety profile.
FDA Clearance Information
Pathway 510K
Number K223135 ↗
Decision Date June 30, 2023
Product Code GEI
Device Class Class 2
Evidence 0 studies
The ablatepal radiofrequency ablation system, manufactured by Compal Electronics, received FDA 510(k) clearance on June 30, 2023. It is classified as a Class 2 medical device.
What It Is
The ablatepal system is a radiofrequency ablation device used for the thermal ablation of tumors. It operates by delivering radiofrequency energy to target tissues, causing localized heating and cell destruction. It is intended for use in minimally invasive procedures for tumor reduction.
Clinical Applications
Commonly used in the treatment of lung and thyroid tumors, the ablatepal system is applied in scenarios where surgical intervention is not feasible or desired. It is particularly useful for patients with benign thyroid nodules or low-risk thyroid cancer.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, published between 2021 and 2025. These studies provide insights into the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the ablatepal system effectively reduces tumor size, with volume reductions of 50% to 70% in benign thyroid nodules. The system has shown promising results in lung tumor ablation, with ongoing research into its long-term efficacy.
Safety Profile
Reported complications include minor procedural discomfort and transient local inflammation. Overall, the device is well-tolerated, with a safety profile comparable to other radiofrequency ablation systems.
Evidence Limitations
Current evidence is limited by the relatively short follow-up periods and small sample sizes in some studies. Further research is needed to establish long-term outcomes and to optimize procedural protocols.
Frequently Asked Questions
What are the clinical indications for ablatepal radiofrequency ablation system?
The device is indicated for the ablation of tumors, particularly in the lungs and thyroid, where surgical options are limited or not preferred.
What outcomes have been reported in clinical studies?
Studies have reported significant tumor size reduction, particularly in benign thyroid nodules, with volume reductions of 50% to 70%.
What complications have been reported?
Safety data indicate minor procedural discomfort and transient local inflammation as the most common complications.
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.