📋 FDA Reference
Barrx Rfa Self Sizing Balloon Catheter
Summary: The Barrx RFA Self Sizing Balloon Catheter is a medical device used for radiofrequency ablation in patients with Barrett's esophagus. It is primarily used by gastroenterologists in endoscopic procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K142364 ↗
Decision Date ?
October 1, 2014
Product Code ?
GEI
Device Class ?
Class 2
Evidence ?
0 studies
The Barrx RFA Self Sizing Balloon Catheter was cleared through the FDA 510(k) pathway on October 1, 2014. It is manufactured by Covidien and classified as a Class II medical device.
What It Is
The Barrx RFA Self Sizing Balloon Catheter is designed for radiofrequency ablation, a procedure that uses heat to remove or destroy tissue. This device features a self-sizing balloon that adapts to the esophagus's diameter, ensuring consistent contact with the tissue. It is used to treat Barrett's esophagus, a condition where the esophageal lining changes, potentially leading to cancer.
FDA-Cleared Indications
- Endoscopic radiofrequency ablation of esophageal tissue in patients with Barrett's esophagus.
- Treatment of Barrett's esophagus containing dysplastic or other abnormal mucosal tissue as specified in the device labeling.
Clinical Applications
- Radiofrequency ablation of dysplastic Barrett's esophageal mucosa during an upper endoscopic procedure.
- Ablation of residual or recurrent Barrett's tissue during staged endoscopic eradication therapy.
- Use of a self-sizing balloon to contact and treat the esophageal lining across varying esophageal diameters.
- Use with compatible endoscopic equipment by trained clinicians in an appropriate procedural setting.
Practical Considerations
- The catheter is introduced through the mouth and positioned in the esophagus under endoscopic visualization; radiofrequency energy is then delivered to the target mucosa.
- The self-sizing balloon is designed to conform to the internal diameter of the esophagus, but clinicians must select and use the device according to the current instructions for use.
- The procedure generally requires upper endoscopy with sedation or anesthesia. Treatment may be performed as an outpatient procedure, depending on the patient's condition and the planned therapy.
- This device is intended for trained clinicians familiar with endoscopy, Barrett's esophagus, radiofrequency ablation, and management of complications such as bleeding, pain, stricture, or perforation.
- MRI safety, compatibility with specific endoscopes or generators, contraindications, and reprocessing or single-use requirements should be confirmed in the current manufacturer labeling. The catheter should not be assumed to be MRI safe without device-specific documentation.
Related Literature
The linked study investigated the use of the Barrx 360 Express RFA catheter in treating Barrett's esophagus-related neoplasia. The study reported initial experiences from the UK and Ireland, suggesting that the device may allow for quicker ablation times and improved outcomes. However, as preliminary results, the study's findings are limited by its scope and sample size.
Frequently Asked Questions
What is Barrx RFA Self Sizing Balloon Catheter used for?
It is used for radiofrequency ablation in patients with Barrett's esophagus to remove or destroy abnormal tissue.
What specialties typically use this device?
Gastroenterologists typically use this device during endoscopic procedures.
What are the FDA-cleared indications?
The device is indicated for the treatment of Barrett's esophagus, particularly in patients with dysplasia or early-stage cancer.
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.