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barrx anorectal rfa wand
Covidien
Summary: The Barrx Anorectal RFA Wand is a medical device used for the ablation of high-grade anal intraepithelial neoplasia. It is typically used by colorectal surgeons and gastroenterologists.
FDA Clearance Information
Pathway
510K
Number
K162802 ↗
Decision Date
January 24, 2017
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Barrx Anorectal RFA Wand was cleared by the FDA via the 510k pathway on January 24, 2017. It is manufactured by Covidien and classified as a Class 2 device.
What It Is
The Barrx Anorectal RFA Wand is a radiofrequency ablation device designed for use in the anorectal region. It delivers controlled radiofrequency energy to ablate dysplastic tissue, particularly in cases of high-grade anal intraepithelial neoplasia. The device is part of a broader category of ablation devices used to treat precancerous lesions and tumors.
Clinical Applications
This device is commonly used in the treatment of high-grade anal intraepithelial neoplasia, a precancerous condition that can lead to anal cancer if left untreated. It is primarily utilized by colorectal surgeons and gastroenterologists in both outpatient and surgical settings. Patients who are at high risk for anal cancer, such as those with HPV-related lesions, are typical candidates for this treatment.
Indications for Use
The FDA indications for the Barrx Anorectal RFA Wand include the ablation of high-grade anal intraepithelial neoplasia. This means it is used to treat precancerous lesions in the anal canal to prevent progression to cancer.
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's size and design are optimized for the anorectal anatomy.
Related Literature
The linked study investigated the safety and efficacy of using the Barrx Anorectal Wand for circumferential ablation of high-grade anal intraepithelial neoplasia. While specific results are not provided, the study aimed to demonstrate the device's effectiveness in reducing lesion size and preventing progression to anal cancer. Limitations include the lack of an available abstract and specific outcome data.
Frequently Asked Questions
What is the Barrx Anorectal RFA Wand used for?
It is used for the ablation of high-grade anal intraepithelial neoplasia to prevent progression to anal cancer.
What specialties typically use this device?
Colorectal surgeons and gastroenterologists are the primary users of this device.
What are the FDA-cleared indications?
The device is indicated for the ablation of high-grade anal intraepithelial neoplasia, a precancerous condition in the anal canal.
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.