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GERD symptoms affects up to 20% of the European population, and up to 6% of them are developing Barrett's esophagus1.
GERD can lead to BE, a primary risk factor for Esophageal Cancer, where incidence rates have been rising 6x annually and 5-year survival rate are only 21.7%2.
Barrx™ RFA is a clinically proven treatment that achieves complete eradication of dysplasia in 80-90% of patient with BE3. The ESGE guidelines recommend RFA in their treatment guidelines for dysplastic Barrett's esophagus4.
Authors: Srinadh Komanduri, Peter J Kahrilas, Kumar Krishnan, et al
Conclusion: Results of this study suggest that EET has long-term durability with low recurrence rates in the treatment of BE. Additionally, proper reflux management is important for adequate treatment of BE patients undergoing EET.
Authors: Nicholas J Shaeen, Prateek Sharma, Bergein Overholt, et al
Conclusion: When compared to the sham procedure, RFA in patients with dysplastic BE resulted in high rates of complete eradication of dysplasia and intestinal metaplasia and reduced disease progression.
Authors: K Nadine Phoa, Frederike GI van Vilsteren, Bas LAM Weusten, et al
Conclusion: Results suggest that RFA substantially reduces the rate of neoplastic progression to high-grade dysplasia and adenocarcinoma over three-year follow-up. Therefore, patients with a confirmed diagnosis of low-grade dysplasia should be considered for ablation therapy.
Authors: Tarun Rustagi, F Scott Corbett, Hiroshi Mashimol
Conclusion: Results suggest that RFA is a safe and effective treatment for CRP.
Authors: Tim McGorisk, Kumar Krishnan, Laurie Keefer, and Srinadh Komanduri
Conclusion: Results demonstrate that RGA treatment of GAVE is safe and effective.
Indications: The Barrx™ 360 Express RFA Balloon Catheter is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including but not limited to, Barrett’s esophagus and esophageal squamous cell neoplasia, defined as moderate grade intraepithelial neoplasia (MGIN), high grade intra-epithelial neoplasia (HGIN), and/or early squamous cell carcinoma (SCC) of the esophagus limited to the lamina propria (i.e., T1m2). The Barrx™ 90, Barrx™ Ultra Long and Barrx™ 60 RFA Focal Catheters are indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, Barrett’s esophagus and esophageal squamous cell neoplasia, defined as moderate grade intraepithelial neoplasia (MGIN), high grade intra-epithelial neoplasia (HGIN), and/or early squamous cell carcinoma (SCC) of the esophagus limited to the lamina propria (i.e., T1m2).
Contraindications: Contraindications include pregnancy, prior radiation therapy to the esophagus, esophageal varices at risk of bleeding, prior Heller myotomy and cosinophilic esophagitis. Risks: The following are transient side effects that may be expected after treatment: chest pain, difficulty swallowing, painful swallowing, throat pain and/or fever. Side effects should be managed by the physician at their discretion. Potential complications include mucosal laceration, minor or major bleeding, endoscopic clipping to manage mucosal laceration or bleeding, perforation of the stomach, esophagus or pharynx, surgery to manage perforation, esophageal stricture, endoscopic dilation to manage stricture, pleural effusion, transfusion secondary to major bleeding, cardiac arrhythmia, aspiration, infection, death.
Important: Always refer to the Instructions For Use (IFU) packaged with the product for complete instructions, indications, contraindications, warnings and precautions.
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