đź“Š Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Radiofrequency thermal ablation of targeted tumor tissue.
- Use in minimally invasive procedures for tumor reduction.
- The available record identifies lung and thyroid applications, but does not provide the complete FDA indications-for-use statement.
Clinical Applications
- Percutaneous radiofrequency ablation of selected lung tumors.
- Radiofrequency ablation of selected thyroid nodules or thyroid tumors when consistent with the device labeling.
- Image-guided thermal destruction of targeted tumor tissue when tumor reduction is the treatment objective.
Reported off-label uses
- Radiofrequency ablation of tumors in other organs, such as the liver, kidney, bone, or adrenal gland, may be described for this device category but should not be assumed to be cleared for this specific system.
- Treatment of recurrent or metastatic disease outside the labeled anatomy may be considered in clinical practice only under appropriate specialist judgment and applicable institutional requirements.
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, 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.
Practical Considerations
- The provided record does not list applicator lengths, active-tip sizes, generator settings, compatible accessories, or the complete FDA labeling; these details should be confirmed in the current instructions for use.
- Use imaging guidance appropriate to the target, such as ultrasound, CT, or another labeled modality, to position the ablation applicator and monitor treatment.
- Radiofrequency ablation requires an appropriate grounding-pad or return-electrode configuration when specified by the system; follow the manufacturer’s setup instructions.
- MRI compatibility is not established by the supplied record. Do not bring the generator, cables, or applicator into the MRI environment unless the labeling specifically identifies them as MR Safe or MR Conditional.
- Potential contraindications and precautions include inability to safely access the target, uncorrected bleeding risk, active infection, implanted electronic devices or metal near the treatment field, and tumor locations where thermal injury to critical structures cannot be avoided.
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.