Objectives of Fundoplication

Requirement TIF Toupet Nissen

Tightens greater curve side of cardia (collar-sling) to lesser curve side (clasp) ü ü üSubmerges distal esophagus into proximal stomach ü ü üRecreates the Angle of His ü ü üCreates an evident valve the length of the fundoplication ü ü üEnveloped esophagus compresses with increasing intragastric pressure ü ü üRestores intraabdominal esophageal length ü ü üTightens phrenoesophageal membrane ü ü üReduces hiatal hernia <2cm ü ü üRepairs hiatal hernia >2 cm and allows closure of crura ü ü

TIF elongates the esophagus and creates a 270-320° esophagogastric valve incorporating and tightening the phrenoesophageal membrane. TIF is based on and closely emulates the surgical principles of more invasive fundoplication techniques.

TIF Meets Fundoplication ObjectivesTIF Procedure

‘By objective measures, the TIF procedure achieves what a fundoplication is expected to achieve – improvement in LES parameters and reduction in acid exposure.’

Reginald Bell, MDEnglewood, CO

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555 Twin Dolphin Drive, Ste. 620 Redwood City, CA 94065 Tel: 650.226.2200 Fax: 650.226.2201 www.endogastricsolutions.com

©2010 EndoGastric Solutions. All rights reserved. EndoGastric Solutions, TIF and EsophyX are registered trademarks of EndoGastric Solutions, Inc.

TIF References1.BarnesWE,HoddinottKM,MundyS,WilliamsMTransoralincisionlessfundoplicationimprovesrefluxsymptomsinlong-timePPI

userswiththerapy-resistantsymptoms:amulticenterretrospectivestudywith120patients.SurgEndosc(inpreparation)2.BellRCW,FreemanKClinicaloutcomesoftransoralesophago-gastricfundoplicationforthetreatmentofgastroesophagealreflux

disease.SurgEndosc(inpreparation)3.CadièreGB,BusetM,MulsV,RajanA,RoschT,EckardtAJ,WeertsJ,BastensB,CostamagnaG,MarcheseM,LouisH,Mana

F,SermonF,GawlickaAK,DanielMA,DeviereJ(2008).AntirefluxtransoralincisionlessfundoplicationusingEsophyX:12-monthresultsofaprospectivemulticenterstudy.WorldJSurg32:1676-88

4.CadièreGB,VanSanteN,GravesJE,GawlickaAK,RajanA(2009).Two-yearresultsofafeasibilitystudyonantirefluxtransoralincisionlessfundoplication(TIF)usingEsophyX.SurgEndosc23:957-964

5.MulsV,MarcheseM,EckardtAJ,CadièreGB,BusetM,RajanA,WeertsJ,BastensB,DeviereJ,LouisH,ManaF,GawlickaAK,DanielMA,CostamagnaGAntirefluxtransoralincisionlessfundoplicationusingEsophyX:three-yearresultsofaprospectivemulticenterstudy.GIEndosc(inpreparation)

6.TestoniPA,CorsettiM,DiPietroS,CastellanetaAG,VailatiC,MasciE,PassarettiS(2010).Effectoftransoralincisionlessfundoplicationonsymptoms,PPIuse,andpH-impedancerefluxesofGERDpatients.WorldJSurg(ePubaheadofprint,21January2010)

Toupet References1.CatarciM,GentileschiP,PapiC,CarraraA,MarreseR,GaspariAL,GrassiGB(2004).Evidence-basedappraisalofantireflux

fundoplication.AnnSurg239:325-372.GuerinE,BetrouneK,ClossetJ,MehdiA,LefebvreJC,HoubenJJ,GelinM,VaneukemP,ElNakadiI(2007).NissenversusToupet

fundoplication:resultsofarandomizedandmulticentertrial.SurgEndosc21:1985-903.HorvathKD,JobeBA,HerronDM,SwanstromLL(1999).LaparoscopicToupetfundoplicationisaninadequateprocedurefor

patientswithsevererefluxdisease.JGastrointestSurg3:583-914.JobeBA,WallaceJ,HansenPD,SwanstromLL(1997).EvaluationoflaparoscopicToupetfundoplicationasaprimaryrepairforall

patientswithmedicallyresistantgastroesophagealreflux.SurgEndosc11:1080-35.SgromoB,IrvineLA,CuschieriA,ShimiSM(2008).Long-termcomparativeoutcomebetweenlaparoscopictotalNissenandToupet

fundoplication:Symptomaticrelief,patientsatisfactionandqualityoflife.SurgEndosc22:1048-53

Nissen References1.Funch-JensenP,BendixenA,IversenMG,KehletH(2008).ComplicationsandfrequencyofredoantirefluxsurgeryinDenmark:a

nationwidestudy,1997-2005.SurgEndosc2.HahnloserD,SchumacherM,CavinR,CosendeyB,PetropoulosP(2002).RiskfactorsforcomplicationsoflaparoscopicNissen

fundoplication.SurgEndosc16:43-73.HunterJG,SwanstromL,WaringJP(1996).Dysphagiaafterlaparoscopicantirefluxsurgery.Theimpactofoperativetechnique.

AnnSurg224:51-74.HunterJG,TrusTL,BranumGD,WaringJP,WoodWC(1996).Aphysiologicapproachtolaparoscopicfundoplicationfor

gastroesophagealrefluxdisease.AnnSurg223:673-6855.LindT(2000).Changingsurgicalprinciplesforgastro-oesophagealrefluxdisease--islaparoscopicfundoplicationjustifiedinthelight

ofsurgicalcomplications?EurJSurgSuppl:31-36.LundellL(2004).Complicationsafteranti-refluxsurgery.BestPractResClinGastroenterol18:935-9457.LundellL,AbrahamssonH,RuthM,RydbergL,LonrothH,OlbeL(1996).Long-termresultsofaprospectiverandomized

comparisonoftotalfundicwrap(Nissen-Rossetti)orsemifundoplication(Toupet)forgastro-oesophagealreflux.BrJSurg83:830-58.LundellL,AttwoodS,EllC,FioccaR,GalmicheJP,HatlebakkJ,LindT,JunghardO(2008).Comparinglaparoscopicantireflux

surgerywithesomeprazoleinthemanagementofpatientswithchronicgastro-oesophagealrefluxdisease:a3-yearinterimanalysisoftheLOTUStrial.Gut57:1207-13

9.LundellL,MiettinenP,MyrvoldHE,HatlebakkJG,WallinL,MalmA,SutherlandI,WalanA(2007).Seven-yearfollow-upofarandomizedclinicaltrialcomparingproton-pumpinhibitionwithsurgicaltherapyforrefluxoesophagitis.BrJSurg94:198-203

10.PearsonFG(1997).Complicationsandpitfalls:BelseyandCollis-Belseyantirefluxrepairs.ChestSurgClinNAm7:513-3211.UrschelJD(1993).Complicationsofantirefluxsurgery.AmJSurg166:68-7012.WaringJP(1999).Managementofpostfundoplicationcomplications.SeminGastrointestDis10:121-9

‘The TIF procedure allows us to do a surgical correction without the same rate of risk, and with faster recovery than what is associated with more invasive laparoscopic or open procedures.’

Mike Thompson, MD Sheffield, UK

Transoral Incisionless FundoplicationTIF Transoral Incisionless FundoplicationTIF

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fun•do•pli•ca•tionPRONUNCIATION: \fən-dō-plī-kā-shən\ FUNCTION: noun : a surgical procedure in which the upper portion of the stomach is wrapped around the lower end of the esophagus and sutured in place as a treatment for the reflux of stomach contents into the esophagus

Transoral Incisionless FundoplicationTIF Transoral Incisionless FundoplicationTIF

A less invasive approach to fundoplicationFundoplication procedures have been used to effectively treat patients with GERD for over 50 years. TIF is a fundoplication procedure performed through the mouth, rather than through abdominal incisions.

fundoplication types(laparoscopic view)

Nissen transabdominal fundoplication360° posterior wrap

Toupettransabdominal fundoplication270° posterior wrap

TIFtransoral fundoplication 270° - 320° anterior wrap

‘The transoral incisionless fundoplication (TIF)…adheres to the fundamental surgical principle which has guided surgical care for GERD for more than 50 years; specifically the creation of a full thickness gastric fundoplication in support of the lower esophageal sphincter.’

ASGS (American Society of General Surgeons) Board of Trustees in a 2009 position statement in support of the TIF procedure

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TIF performs similarly to the Nissen and Toupet procedures in standard measures of clinical efficacy

TIF Toupet Nissen

GERD-HRQL improved by ≥ 50% 70-92% 65-95% 61-97%

Off daily PPIs 72-97% 65-92% 79-99%

Esophagitis reduced 67-90% 82-89% 86-95%

Hiatal hernia reduced 60-89% 90-95% 87-99%

TIF reduces the risk of complications associated with more invasive fundoplication procedures

TIF Nissen

Intraoperative complications:

Perforations 0.1% 1-4%

Postoperative complications:

Abdominal pain 9-14% 10-40%

Dysphagia 0-11% 44-90%

Diarrhea 0-5% 18-20%

Gas bloat 3-59% 10-82%

Nausea 2-11% 8-21%

Long-term complications:

Chronic dysphagia 0% 2-6%

Gas bloat syndrome 0% 9-62%

Reoperation 0% 4-8%

Mortality 0% 0.5-3%

Clinical Results

TIF delivers sustainable results

% of patients with GERD-HRQL scores improved by ≥ 50% vs. baseline off PPIs

6 months 12 months 24 months 36 months0

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Viewed endoscopically, transoral and laparoscopic fundoplication valves are very similar.

TIF Laparoscopic Fundoplication

‘This is incisionless surgery with REAL results for a lot of people, and we can do it right now.’

Mark Gibbs, MDLittle Rock, AR

TIF valves have a vector volume (3-D manometry) profile similar to those of normal and Nissen valves. This change in pressure and length of the high-pressure zone (HPZ) is believed to result in antireflux barrier competence.