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barrx anorectal rfa wand
Covidien
Summary: The Barrx Anorectal RFA Wand is a medical device used for radiofrequency ablation of anal canal lesions, particularly high-grade anal intraepithelial neoplasia. It is primarily used by colorectal surgeons and gastroenterologists.
FDA Clearance Information
Pathway
510K
Number
K150251 ↗
Decision Date
July 28, 2015
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Barrx Anorectal RFA Wand was cleared through the FDA 510(k) pathway on July 28, 2015. Manufactured by Covidien, it is classified as a Class 2 device under product code GEI.
What It Is
The Barrx Anorectal RFA Wand is a specialized device designed for the ablation of anal canal lesions using radiofrequency energy. It works by delivering controlled thermal energy to targeted tissue, causing cellular destruction while minimizing damage to surrounding areas. This device is particularly useful for treating high-grade anal intraepithelial neoplasia, a precancerous condition.
Clinical Applications
Clinically, the Barrx Anorectal RFA Wand is used in procedures aimed at treating precancerous lesions in the anal canal. It is commonly employed in outpatient settings by colorectal surgeons and gastroenterologists. The device is particularly beneficial for patients with high-grade anal intraepithelial neoplasia, helping to prevent progression to anal cancer.
Indications for Use
The FDA-cleared indications for this device include the treatment of high-grade anal intraepithelial neoplasia. This condition involves abnormal cell growth in the anal canal, which can potentially progress to cancer if not treated effectively.
Practical Considerations
The Barrx Anorectal RFA Wand is designed to be compatible with standard endoscopic equipment. Clinicians should be trained in radiofrequency ablation techniques to ensure effective and safe use. The device is typically available in sizes suitable for the anal canal, and proper sizing is crucial for optimal outcomes.
Related Literature
The linked study investigated the safety and efficacy of circumferential anal canal radiofrequency ablation using the Barrx Anorectal Wand for high-grade anal intraepithelial neoplasia. Although the abstract is not available, the study likely focused on evaluating the device's ability to effectively ablate targeted lesions while minimizing complications. Limitations may include the lack of long-term outcome data and a small sample size.
Frequently Asked Questions
What is Barrx Anorectal RFA Wand used for?
It is used for the radiofrequency ablation of high-grade anal intraepithelial neoplasia to prevent progression to anal cancer.
What specialties typically use this device?
Colorectal surgeons and gastroenterologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the treatment of high-grade anal intraepithelial neoplasia.
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.