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Barrx Channel Rfa Endoscopic Catheter
Summary: The Barrx Channel RFA Endoscopic Catheter is a device used for radiofrequency ablation in endoscopic procedures, primarily for treating esophageal conditions. Key evidence includes successful treatment of esophageal papilloma.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K130623 ↗
Decision Date ?
July 26, 2013
Product Code ?
KNS
Device Class ?
Class 2
Evidence ?
0 studies
The Barrx Channel RFA Endoscopic Catheter was cleared by the FDA via the 510(k) pathway on July 26, 2013. It is manufactured by Covidien and classified as a Class 2 device.
What It Is
The Barrx Channel RFA Endoscopic Catheter is a medical device designed for radiofrequency ablation during endoscopic procedures. It is intended for use in the ablation of abnormal tissue in the gastrointestinal tract.
FDA-Cleared Indications
- Radiofrequency ablation of abnormal tissue in the gastrointestinal tract during endoscopic procedures.
- Use in the treatment of selected esophageal lesions when the procedure is clinically appropriate.
Clinical Applications
- Endoscopic radiofrequency ablation of abnormal esophageal tissue.
- Treatment of selected Barrett's esophagus–associated dysplastic tissue as part of an endoscopic management plan.
- Ablation of selected esophageal lesions identified during upper gastrointestinal endoscopy.
Evidence Summary
The available literature includes two studies, one published in 2015 and another with an unknown date. The studies involve different types of research, including case reports and clinical trials.
Reported Outcomes
Published studies report successful ablation of esophageal papilloma using the Barrx Channel RFA Endoscopic Catheter. The device has been shown to effectively treat lesions with minimal sessions.
Safety Profile
Reported complications include typical risks associated with endoscopic procedures, such as minor bleeding and discomfort. No severe adverse events were noted in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and safety profiles.
Practical Considerations
- The catheter is used through a compatible endoscope and requires appropriate radiofrequency ablation equipment.
- Treatment is performed under endoscopic visualization, typically with sedation or anesthesia selected by the treating team.
- The device is intended for single use; follow the current product labeling for handling, electrode positioning, energy settings and compatibility.
- MRI safety should be confirmed in the current manufacturer labeling; a radiofrequency ablation catheter should not be assumed to be MRI safe while in place.
- Contraindications, precautions and treatment limits depend on the lesion, anatomy, patient condition and the current instructions for use.
Frequently Asked Questions
What are the clinical indications for Barrx Channel RFA Endoscopic Catheter?
The device is indicated for the ablation of abnormal tissue in the esophagus, such as Barrett's esophagus and esophageal papilloma.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful ablation of esophageal papilloma with minimal sessions using the device.
What complications have been reported?
Safety data from evidence indicate minor bleeding and discomfort as potential complications, with no severe adverse events reported.
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.