Captivator EMR Device

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1 Device Clinical Article and Abstract Summary Endoscopic Mucosal Bergman et al: EMR Training Tips Bergman et al: EMR Learning Curve ASGE: EMR & ESD Guidelines Bergman et al: Captivator EMR vs Cook Duette ASGE: Barrett s Early Cancer Guidelines ASGE: EMR Guidelines Bergman et al: Captivator EMR vs Multiband Mucosectomy Use of EMR as a Elsadek & Radwan: Biopsy vs. EMR for Diagnostics Lin: Limitations of EUS, Benefits of EMR for Diagnostics Wang: Background & Benefits of EMR Waxman: Captivator EMR for Staging Over-use of Bosworth: EMR, Surgical Alternative Morales: Importance of Flattening Specimens

2 Device 1 of 3 Learning Endoscopic in the Esophagus J.J.G.H.M. Bergman et al. This study summarizes the most important learning points for EMR encountered during a structured endoscopic resection training program using Cook Duette. Included in tips are: Importance of lesion visualization Delineating lesion by marking Complication management handling Learning to Perform Endoscopic of Esophageal Neoplasia is Associated with Significant Complications Even within a Structured Training Program J.J.G.H.M. Bergman et al. EMR should be performed by trained endoscopists in centers with multidisciplinary experience of endoscopic resection to ensure adequate treatment of complications. Greater than 20 endoscopic resections are needed to overcoming learning curve of EMR. EMR is associated with a 5% perforation rate. and Endoscopic Submucosal Dissection ASGE EMR has emerged as an important therapeutic option for premalignant and early stage GI malignancies. EMR techniques aid in the diagnosis and therapy of subepithelial lesions localized to the muscularis mucosa or submucosa. This report focuses on instruments, injection solutions, and techniques currently used during EMR and ESD.

3 Device 2 of 3 In Vitro Assessment of the Performance of a New Multiband Mucosectomy Device for Endoscopic of Early Upper Gastrointestinal Neoplasia J.J.G.H.M. Bergman et al. Captivator EMR has many advantages over Cook Duette. Compared to the Cook Duette Device, the Captivator EMR Device is associated with improved endoscopic visibility, smoother passage of endoscopic devices, and marginally improved suction power. The Role of Endoscopy in Barrett s Esophagus and Other Premalignant Conditions of the Esophagus ASGE EMR as an eradication technique for high grade dysplasia and early adenocarcinoma is successful in 91% to 98% of T1a cancers. This guideline discusses the role of endoscopy in the management of premalignant conditions of the esophagus including recommendations of when to use EMR.

4 Device 3 of 3 ASGE EMR was developed for minimally invasive, organ-sparing endoscopic removal of benign and early malignant lesions in the GI tract. This report focuses on instruments, injection solutions, and techniques currently used for EMR. Randomized Trial on Endoscopic -cap vs. Multiband Mucosectomy for Piecemeal Endoscopic of Early Barrett s Neoplasia J.J.G.H.M. Bergman et al. Multiband mucosectomy (MBM) is preferred over Cap EMR (Olympus) for early Barrett s neoplasia. Injection for submucosal lifting prior to MBM does not decrease risk of bleeding or perforation. 40% of patients undergoing MDM had intraprocedural bleeds that were successfully treated endoscopically. No delayed bleeds were reported.

5 Device 1 of 2 Diagnostic Accuracy of Mucosal Biopsy vs in Barrett s Esophagus and Related Superficial Lesions Hany M. Elsadek and Mamdouh M. Radwan EMR is crucial before proceeding to endoscopic ablation therapy or surgery. Standard biopsies are not sufficient for accurate diagnosis and classification of dysplasia and neoplasia in the esophagus in patients with BE and its related superficial esophageal lesions. An upgrading diagnosis was made by EMR (i.e., a higher degree of dysplasia or neoplasia than that diagnosed with biopsy) in 18 cases (37.5%) A downgrading diagnosis was made by EMR (i.e., a lower degree of dysplasia or neoplasia than that diagnosed with biopsy) in two cases (4.17%). T1 esophageal Cancer, Request an (EMR) for In-Depth Review James L. Lin The role of EUS in clinical decision making of early stage esophageal adenocarcinoma is questioned. EMR provides accurate staging data and provided information for patient management. Despite a normal EUS, after EMR 25 out of the 105 patients had risk factors for lymph node metastasis that would have been missed without corresponding histology resulting in undertreatment. Conversely in the 26 patients who had an EUS suggestive of submucosal invasion or lymph node metastasis, EMR revealed no risk factors for lymph node metastasis in 10 of these patients. Referral to surgery based on the EUS findings would have subjected these patients to over-treatment.

6 Device 2 of 2 in the Management of Esophageal Neoplasia: Current Status and Future Directions Vikneswaran Namasivayam, MBBS, Kenneth K. Wang, MD, and Ganapathy A Prasad, MD, MS EMR is curative for lesions restricted to the mucosa and may be considered in selected patients with submucosal disease and no lymphovascular invasion. Long term outcomes of subjects treated with EMR alone or in combination with ablative techniques appear to be comparable to those treated with esophagectomy. EMR has 94-96% complete remission rates for HGD and intramucosal adenocarcinoma. The findings on EMR changes the eventual management by upstaging the grade of dysplasia originally seen on biopsy in as much as 34%. Overall complication rate of EMR is 13-17%. The most common complications are bleeding, strictures, and perforation. Serious complications are rare. Jennifer Chennat and Irving Waxman EMR is the only endoscopic modality which serves the dual function of curative potential and provision of more accurate histo-logical staging. EMR resulted in a 45% rate of upstaging or downstaging of final BE neoplasia histology when comparing pre-emr biopsies with resection specimens

7 Device Equivalent to for Patients with Early Esophageal Cancer Ted Bosworth 74% of patients who could have had an EMR got an esophagectomy. 1,098 patients meeting the definition of early esophageal adenocarcinoma were treated between 1998 and Of these, 283 (26%) underwent endoscopic therapy, usually in the form of EMR, as their first procedure. The remainder of the patients were initially treated with surgical resection. Most of these patients received total esophagectomy with partial gastrectomy.

8 Device A Simple Tissue-Handling Technique Performed in the Endoscopy Suite Improves Histologic Section Quality and Diagnostic Accuracy for Serrated Polyps Shannon John Morales, Carol A. Bodian, Susan Kornacki, et al. Flattening specimens leads to improved pathology reads compared to only dropping in formalin. Flattening specimen resulted in a decrease in requests from pathologist for deeper tissue sections from 31.8% to 11.1 %. Flattening specimens increased the diagnosis rate from 40.3% to 75.6 %. Flattening specimens increased inter-pathologist concordance on diagnosis from 62.8% to 77.0 %

9 All trademarks are the property of their respective owners. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA Boston Scientific Corporation or its affiliates. All rights reserved. ENDO AA January 2016

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