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Captivator EMR Device The Captivator EMR Device isspecifically designed for ligation-assistedEndoscopic Mucosal Resection (EMR)of the Upper Gastrointestinal (GI) tract“A device specifically designed for EMR may leadto greater overall efficiency in regards to optimalvisualization and device exchange as well asproviding a way to consistently handle tissue.”— Dr. Ram Chuttani,Beth Israel Deaconess Medical CenterThis is EMR.KitComponentsImportanceof eringInformationResources
Kit ComponentsCaptivator EMREndoscopic Mucosal Resection DeviceCaptivator EMR Band LigatorDesigned to achieve 360 degreeperipheral viewing withoutobstructions due to the ligatorbands, includes 6 bandsAccess PortAllows passability of7Fr tools with device inplace (Interject InjectionTherapy Needle Catheter/Resolution Clip)HandleBlue knob isrotated 120 andis designed withtactile and audiblefeedback to signalwhen a band hasdeployedKitComponentsImportanceof EMRCaptivator EMR SnareStiff snare and banddesign provides abilityto snare where desired(above or below the aptivator EMRPathology KitIncluded for histologicalprocessing of retrieved tissuesamples which may allow forbetter specimen handlingOrderingInformationResources
Importance of EMRCaptivator EMREndoscopic Mucosal Resection DeviceEndoscopic management of Barrett’s Esophagus mayhelp reduce the potential for an invasive and costlysurgical esophagectomy.The Captivator EMR Device provides potential clinical, economic, efficiency,and patient satisfaction benefits for EMR procedures:The EMR procedure isthe only endoscopicmodality which servesthe dual function ofcurative potentialand provision of moreaccurate histologicalstaging.1 Delivers a minimally invasive device, for use in the treatmentof patients requiring EMR, including Barrett’s Esophagus andEsophegeal AdenocarcinomaTap Here Offers significant visualization improvements over other EMRTap Heredevices with 360 degree unobstructed peripheral viewing Designed to help improve physician control in band deployment,tissue capture and complication management with device in place. Offers potential for improved pathology handling, with includedpathology kit, which may provide the user with greater convenience. May help to generate time savings in both establishing visualizationand managing complicationsKitComponentsImportanceof EMRTreatmentConsiderationsFeaturesTap HereTap HereTap HereEconomicValueOrderingInformationResources
Treatment ConsiderationsCaptivator EMREndoscopic Mucosal Resection DeviceEndoscopic management strategies forBarrett’s esophagus2HistologyIntervention OptionsNon-DysplasticBarrett’s Esophagus(NDBE) Consider no surveillance. If surveillance is elected, perform EGD every 3-5 years withIndeterminateGrade Dysplasia(IGD) Clarify presence and grade of dysplasia with expert GI pathologist. Increase antisecretory therapy to eliminate esophageal inflammation. Repeat EGD and biopsy to clarify dysplasia status.Low GradeDysplasia(LGD) High GradeDysplasia(HGD) Confirm with expert GI pathologist. Consider surveillance EGD every 3 months in select patients,Multibandmucosectomy iseffective in achievingradical removalof early Barrett’sneoplasia and doesnot appear to resultin more perforationsor bleeding episodesthan the endoscopicresection-captechnique, despite thelack of submucosallifting.34-quadrant biopsies every 2 cm. Consider endoscopic ablation in select cases.Confirm with expert GI pathologist.Repeat EGD in 6 months to confirm LGD.Surveillance EGD every year, 4-quadrant biopsies every 1-2 cm.Consider EMR or ablation.4-quadrant biopsies every 1 cm. Consider EMR or RFA ablation. Consider EUS for local staging and lymphadenopathy. Consider surgical consultation.“A distinct advantage of EMR over ablative therapy is the availability of large tissue specimens forpathologic examination and cancer ents EMR is indicated for shorter segment dysplastic BE, nodular dysplasia,superficial (T1a) EAC, and esophageal squamous cell carcinoma (ESC). EMR as an eradication technique for HGD and EAC is successful in91% to 98% of T1a cancers.Importanceof eringInformationResources
FeaturesCaptivator EMREndoscopic Mucosal Resection DeviceOptimal Visualization1 of 3The Captivator EMR Band Ligatorcap is designed to achieve 360degree peripheral viewing withoutobstructions due to the ligator bands Clear visualization plays an important role inthe procedure Captivator EMR Device allows the physician to see andassess the tissue/lesion when the EMR device is inplace and to see tissue during suctionBetter VisualizationWhen combining thevisualization through theopening and the plastic ofthe cap, the CaptivatorEMR Device allowsvisualization of 90% of theendoscopic view directlyafter mountingthe device.4With Cook Duette MultiBand Mucosectomy device,visualization of 90% is notreached until releasing 4 ofthe 6 rubber bands.4Limited VisualizationKitComponentsImportanceof eringInformationResources
FeaturesCaptivator EMREndoscopic Mucosal Resection DeviceComplicationManagementFeatures: ComplicationManagement2 of 3The Captivator EMR Device offers the ability to managecomplications with the device in place The types of potential complications during an EMR procedure may include bothbleeding and perforation.* About 40% of patients who undergo EMR have minor interprocedural bleedingthat can be treated endoscopically.3 Injection needle can be used for submucosal injection, which may help thephysician to assess signs of non-lifting, or to help assess invasion and/or fibrosis†The Captivator EMR device is compatible with 7Fr devices such as theInterject Injection Therapy Needle Catheter and the Resolution ClipAll devices did passsignificantly moresmoothly with theCaptivator EMR.4†Interject Injection Therapy Needle CatheterResolution Clip*Reference the directions for use, for a complete list of potential complications.KitComponentsImportanceof eringInformationResources
FeaturesCaptivator EMREndoscopic Mucosal Resection DeviceConsistent and Optimal Tissue HandlingThe Captivator EMR pathology kit is included to aid inhistological processing of retrieved tissue sampleswhich may allow for better specimen handling.KitComponentsImportanceof EMRTreatmentConsiderationsFeatures3 of 3Because EMRspecimens arelarger than biopsysamples, it is helpfulfor pathologicinterpretation toorient and mountthe specimen beforesubmerging it ces
Economic ValueCaptivator EMREndoscopic Mucosal Resection DeviceThe Captivator EMR device offers clinicians the ability to managecomplications with the device in place Less time spent switching out devices and less likelihood of needing a 2nd scope and device during the procedure.A potential cost savings of 290 per case*The Captivator EMR device is designed to achieve 360 peripheral viewingwithout obstructions Offers an efficient way to visualize a complication and may allow more rapid treatment of the complication duringthe same procedure.Includes a pathology kit, to incorporate the latest clinical thinking in thehandling of specimens and may provide added convenience for endoscopistsand pathologistsEsophagectomyEMR2012 Mean Medicare Hospital Costs 49,792 2,2972012 Mean Medicare Payment 30,040 1,776Length of Stay (days)12.9OutpatientDelivers a minimally invasivetreatment option for patients withBarrett’s Esophagus and appearsto be less costly to the hospital ona per procedure basis and may beassociated with a shorter length ofstay versus esophagectomy.6*Assumes 250 replacement device cost and 40 scope reprocessing cost.KitComponentsImportanceof eringInformationResources
Ordering Information Captivator EMRCaptivator EMREndoscopic Mucosal Resection DeviceScope Compatibility1 of 3Our Standard Kit (M00561600) is designed to be compatiblewith gastroscopes with a physical dimension at the distal endof 9.0mm – 9.9mm. While most diagnostic gastroscopes(2.8mm working channel) will fit these dimensions, it isimportant to verify with the scopes at your hospital.Our Large Kit (M00561610) is designed to be compatiblewith gastroscopes with a physical dimension at the distal endof 11.3mm – 11.6mm. While most therapeutic gastroscopes(3.7mm working channel) will fit these dimensions, it isimportant to verify with the scopes at your hospital.Captivator EMR Product CodesCaptivator EMR DeviceOrder NumberGTINProduct DescriptionUnitM0056160008714729842675Captivator EMR Device for Standard GastroscopesBox 1M0056160108714729842682Captivator EMR Device for Standard GastroscopesBox 5M0056161008714729842699Captivator EMR Device for Large GastroscopesBox 1M0056161108714729842705Captivator EMR Device for Large GastroscopesBox 5Reimbursement and Ordering InformationResolution ClipCPT CodeCode Description43254EGD, Endoscopic Mucosal Resection (EMR)43211Esophagoscopy, Endoscopic Mucosal Resection (EMR)Note: Payer policies will vary and should be verified to treatment for limitations on diagnosis, coding or site of service requirements. The coding option listed within this guide is commonlyused but is not intended to be all inclusive. We recommend consulting your relevant manuals for appropriate coding options.KitComponentsImportanceof eringInformationResources
Ordering Information Complementary DevicesCaptivator EMREndoscopic Mucosal Resection DeviceResolution Clip Product Codes2 of 3Resolution ClipOrder NumberGTINWorking 2601087147295047711552.811Box 10M00522602087147295047881552.811Box 47295048012352.811Box 10M00522612087147295048182352.811Box 20KitComponentsImportanceof EMRMinimum WorkingChannel (mm)Clip omicValueOrderingInformationResources
Ordering Information Complementary DevicesCaptivator EMREndoscopic Mucosal Resection DeviceInterject Injection Therapy Needle Catheter Product Codes3 of 3Interject Contrast Single-Use Injection Therapy Needle Catheters*Order NumberGTINSheathDesignNeedleGaugeMaximum NeedleExtension Length (mm)Sheath O.D.(mm)Working 8200Box 5M0051816108714729296447Contrast2541.8200Box 5M0051825108714729296478Contrast2361.8200Box 5M0051826108714729296485Contrast2561.8200Box 5M0051835108714729296522Contrast2342.3240Box 5M0051836108714729296539Contrast2542.3240Box 5*With Star Catheter Technology.Interject Clear Single-Use Injection Therapy Needle Catheters*M0051810108714729296416Clear2341.8200Box 5M0051811108714729296423Clear2541.8200Box 5M0051830108714729296508Clear2342.3240Box 5M0051831108714729296515Clear2542.3240Box 5*With Star Catheter Technology.KitComponentsImportanceof eringInformationResources
ResourcesCaptivator Captivator EMREndoscopic Mucosal Resection Devicev a l ue a na l y si s bri e fIrrigation AdaptorEMR DeviceCaptivator EMR DeviceThe Captivator EMR Deviceis specifically designed for ligation-assisted EndoscopicMucosal Resection (EMR) of the Upper Gastrointestinal (GI)tract. Many physicians are now adopting Upper GI EMR as theyHandleMethodThis value analysis brief provides information on the practice of ligation-assisted Endoscopic Mucosal Resection (EMR) of the Upper Gastrointestinal(GI) tract and the potential clinical and economic benefits of the Captivator EMR Device. Many physicians are now adopting Upper GI EMR as theyrecognize the benefits of the procedure to treat precancerous conditions and superficial cancers of the esophagus including Barrett’s Dysplasia (LGD,HGD), Mild/Moderate Squamous Cell Neoplasia, and T1a and some T1b cancers.1recognize the benefits of the procedure to both diagnose andBackgroundtreat precancerous conditions and superficial cancers of theBarrett’s Esophagus is the central step on the disease continuum from GERD (gastroesophageal reflux disease) to Esophageal Cancer; it begins as aserious complication of GERD. In Barrett’s esophagus, the normal squamous epithelium lining of the esophagus is replaced by goblet cells from thestomach. Patients with Barrett’s Esophagus have a 50x - 100x increase in their risk of developing cancer compared to the general population.2esophagus including Barrett’s Dysplasia (LGD, HGD), Mild/Moderate Squamous Cell Neoplasia, and T1a and some T1bcancers. The Captivator EMR Device has 510(k) clearance1per K140726, for commercialization in the United States.Barrett’s Esophagus does not just have a negative clinical impact on patients’ lives – the economic burden of the disease is also high. Controlling forage, gender, and number of comorbidities, patients with Barrett’s Esophagus incur 21.2% higher overall costs than patients with GERD and 62.4%higher overall costs than the general Medicaid population.3 Endoscopic management of Barrett’s Esophagus may help reduce the potential for anPathology KitCaptivator EMR DevicePreparation for UseThe Captivator EMR Device is specifically designed forligation-assisted Endoscopic Mucosal Resection (EMR)of the Upper Gastrointestinal (GI) tract.Captivator EMR SnareLigator CapViewCart ChartTap Hereinvasive and costly surgical esophagetomy.The Captivator EMR Device provides a minimally invasive management option for Barrett’s Esophagus. The Captivator EMR Device includes:The Captivator EMR device includes: Captivator EMR Band Ligator Captivator EMR Snare Captivator EMR Pathology Kit Captivator EMR Band Ligator Captivator EMR Snare Captivator EMR Pathology KitPotential Clinical and Economic BenefitsEconomic and Clinical ValueClinical ConsiderationsIntended BenefitSee and assess tissue / lesion with theEMR device in placeThe Captivator EMR Band Ligator cap is designed with 360 degree peripheralviewing without obstructions by bandsSee and assess complications duringthe procedurePassability of 7Fr tools with device in place (Interject Needle / Resolution Clip*)Assessment of the complication for managementCap visualization allows physician to see tissue during suctionTissue CaptureStiff snare and band design allows the physician to snare where desired(above or below the band)Standardized tissue handling may assistpathologist’s determination of tissue margins1Pathology kit included for histological processing of retrieved tissue sampleswhich may allow for better specimen handlingEconomic ConsiderationsPotential BenefitsReduce likelihood of using a 2nd scopeduring the procedurePassability of 7Fr tools with device in place (Interject/Resolution Clip*)Reduce likelihood of unintendedband deploymentHandle designed with tactile and audible feedback to signal when a bandhas deployedProcedural efficiency The Captivator EMR Device is designed to enable physicians to exchangedevices with the device in place Designed to allow for adequate suction when both the snare and trip wireare in the working channelThe Captivator EMR Device delivers a minimally invasive treatment option for patients with Barrett’s Esophagus.4 A retrospective claims analysis ofMedicare inpatient and outpatient (MedPar and OPPS FY 2012) files was conducted to compare length of stay (LOS), hospital costs and paymentsbetween both procedures. Given that upper Gastro-Intestinal (GI) tract EMR codes did not exist in 2012, various coding combinations utilized byhospitals to report the EMR procedure were identified in the claims file. The mean total hospital costs for esophagectomy were significantly greaterthan EMR ( 49,792 vs. 2,297, respectively). Mean post-procedure LOS for esophagectomy was 12.9 days. LOS was not calculated for EMR as theprocedure is primarily performed in the outpatient hospital setting. Based on these findings, EMR appears to be less costly to the hospital on a perprocedure basis and may be associated with a shorter length of stay than esophagectomy.5EsophagectomyTotal HospitalizationsEMR1702222012 Mean Medicare Hospital Costs 49,792 2,2972012 Mean Medicare Payment 30,040 1,77612.9OutpatientLength of Stay (days)Device Set-UpClear visualization plays an important role in the outcomeof the procedure; poor visualization “makes it moredifficult to target focal lesions and avoid tissue bridgesbetween multiple resection areas.”6 The Captivator EMRBand Ligator cap is designed to achieve 360 degreeperipheral viewing without obstructions due to theligator bands. This allows the physician to see and assessthe tissue/lesion when the EMR device is in place. To theright is a visualization comparison of Captivator EMRDevice and a competitive device.Captivator EMR DeviceCompetitive EMR Device*Resolution Clip is compatible with Captivator EMR Device for Large Gastroscopes1GIE 2008, Volume 68, No. 1ViewVAT SheetViewAnalysis BriefViewSetup VideoTap HereTap HereTap HereKitComponentsImportanceof eringInformationResources
References1. Jennifer Chennat. Irving Waxman. Interventional Gastrointestinal Oncology 2. GastrointestinalOncology, A Practical Guide 20112. ASGE, The role of endoscopy in Barrett’s esophagus and other premalignant conditions of theesophagus. Gastrointestinal Endoscopy, 2012 76(6)3. Pouw, Roos E, et al. Randomized trial on endoscopic resection-cap versus multibandmucosectomy for piecemeal endoscopic resection of early Barrett’s neoplasia. ClinicalEndoscopy 2011; 74 (1)4. Schölvinck, D.W., Belghazi, K., Pouw, R.E., Curvers, W.L., Wuesten, B.L.A.M., Bergman,J.J.G.H.M., In vitro assessment of the performance of a new multiband mucosectomy devicefor endoscopic resection of early upper gastrointestinal neoplasia. Surg Endosc, 20155. ASGE Technology Committee, Hwang, J.H. MD, PhD, FASGE, et al. Endoscopic mucosalresection. Gastrointestinal Endoscopy, 2015; 82 (2)6. 1 Datasource: Medicare’s MedPar 2012 and Medicare’s OPPS 2012 (Outpatient ProspectivePayment System) filesAll trademarks are the property of their respective owners.Indications, Contraindications, Warnings and Instructions for Use can be found in the productlabeling supplied with each device.Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752-1234www.bostonscientific.com/gastro 2016 Boston Scientific Corporationor its affiliates. All rights reserved.ENDO-338919-AB February 2016
43254 EGD, Endoscopic Mucosal Resection (EMR) 43211 Esophagoscopy, Endoscopic Mucosal Resection (EMR) Note: Payer policies will vary and should be verified to treatment for limitations on diagnosis, coding or site of service requirements. The coding option listed within this guide is commonly used but is not intended to be all inclusive.
