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barrx rfa self sizing balloon catheter
Covidien
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
510K
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.
Clinical Applications
This device is commonly used in the treatment of Barrett's esophagus, especially in patients with dysplasia or early neoplasia. Gastroenterologists use it during endoscopic procedures to ablate abnormal tissue. It is typically used in outpatient settings, and the procedure is minimally invasive, allowing for quicker recovery times.
Indications for Use
The Barrx RFA Self Sizing Balloon Catheter is indicated for patients with Barrett's esophagus, particularly those with precancerous changes or early-stage cancer. It is used to remove or destroy abnormal tissue in the esophagus to prevent progression to esophageal cancer.
Practical Considerations
The device's self-sizing feature allows it to adapt to various esophageal sizes, simplifying the procedure. It is compatible with standard endoscopic equipment. Clinicians should be trained in endoscopic techniques and familiar with the device's operation to ensure optimal outcomes.
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.