VISIONIST™ X4 CRT-P and VISIONIST™ CRT-PModels U225, U226, U228

•ProvidesanImageReady™MRConditionalsystem*at3Tand1.5T,fullbody,withnotimelimitations,withautomaticMRItimeoutfeaturetooptimizeworkflowintheMRenvironment

•ExtendedLongevitydeviceprojectedtolastupto13.8years**•TheX4CRT-PandACUITY™X4leadportfoliofeatures: –electrodesona3Dspiraldesignedtoallowpacingfroma

basallocationwithoutsacrificingfixationorthresholds –17pacingoptionstomanagephrenicnervestimulationand

highthresholds –multipleleadshapeswitha2.6F(0.86mm)taperedlead

tiptoimprovepredictabilityofaccessingtargetvessels•AdvancedAFandHFdiagnosticreportsprovidea

comprehensiveandproactiveapproachforcomorbiditymanagement

•RFtelemetryforwirelesstransmissionofinformationandefficiencyintheoperatingroomandfollow-upsetting

•RemotepatientmonitoringwiththeLATITUDE™NXTPatientManagementSystem

•RightRate™MVsensoristheonlyMVsensorclinicallyproventorestorechronotropiccompetence1

•Enhancedfeaturesanddiagnostics,includingAPScan™andRespiratoryRateTrend,designedtoprovideyouwithgreaterinsightintoyourpatient’sdiseaseprogressionbasedonthepatient’sownrespiration

•POSTfunctiontofacilitatepatientfollowupwithafullyautomaticdeviceandleadcheck•EASYVIEW™headerwithportidentifiersdesignedtomaketheimplantexperiencemoreefficient*Model U228 only. When conditions of use are met, please refer to MRI Technical Guide.

**Assumes 70 min-1 LRL, DDDR mode; 100% biventricular pacing; 15% atrium pacing and 0.4 ms pacing. Pulse Width (RA, RV, LV); RA 500 Ω; RV/LV 700Ω; sensors Off, EGM Onset On.

Mechanical Specifi cations Size (cm) Connector Type Model Type (W x H x D) Mass (g) Volume (cc) (RA RV LV)

U225 (non-MRI model) CRT-P 4.45x6.13x0.75 30.6 15.2 RA/RV/LV:IS1

U226 (non-MRI model) CRT-P 4.45x6.13x0.75 31.1 15.2 RA/RV:IS1–LV:LV1

U228 X4CRT-P 4.45x6.17x0.75 33.0 16.6 RA/RV:IS1–LV:IS4

• Assumes70min-1LRL,DDDRmode;100%biventricularpacing;15%atriumpacingand0.4mspacing.PulseWidth(RA,RV,LV);RAImpedance500Ω;sensorsOn,EGMOnsetOn.Thesecalculationsalsoassumethatthepulsegeneratorspends6monthsinStoragemodeduringshippingandstorage,theZIP™telemetryusefor3hoursatimplanttimeandfor40minutesannuallyforin-clinicfollow-upchecks.

• PowerSupply:lithium-carbonmonofluoridecell;BostonScientific;40229.

Additional Longevity Information

Longevity

Projected Longevity RA/RV LV 500Ω 700Ω700Ω,

no MV/RS

Typicalprogrammedsetting 2.5V 3.0V 10.3 11.2 11.7

Maximumlabeledlongevity 2.0V 2.0V 12.4 13.1 13.8

VISIONIST™ X4 CRT-P and VISIONIST™ CRT-PModels U225, U226, U228

1. ChronotropiccompetenceisdefinedbytheModeloftheCardiacChronotropicResponsetoExercise.WilkoffB,CoreyJ,BlackburnG.Amathematicalmodelofthecardiacchronotropicresponsetoexercise.JournalofElectrophysiology.1989;3:176–180.

All cited trademarks are the property of their respective owners. CAUTION:Thelawrestrictsthesedevicestosalebyorontheorderofaphysician.Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.GuidantCorporationandGuidantEuropenv/saareBostonScientificcompanies.InformationcontainedhereinisfordistributionoutsidetheU.S.only.InformationnotintendedfordistributioninFrance.

CRM-251102-ACProducedbyGosling.

©2018BostonScientificCorporationoritsaffiliates.Allrightsreserved.DINCRM0851EB

Pacing TherapyBrady Modes Normal:DDD(R)-DDI(R)-VDD(R)-VVI(R)-AAI(R)-DOO-VOO-

AOO-Off

Temporary:DDD-DDI-VDD-VVI-AAI-DOO-VOO-AOO-Off

AT/AF Management ATRModeSwitch,VentricularRateRegulation(VRR),AtrialFlutterResponse(AFR),AtrialPacingPreference(APP),ProACt,RateSmoothing

Automaticity AutomaticGainControl(AGC)forsensitivity

RightAtrialAutomaticThreshold(RAAT)

RightVentricularAutomaticThreshold(RVAT)

LeftVentricularAutomaticThreshold(LVAT)*

Rate Adaptive Pacing Accelerometer,RightRate™(MinuteVentilation)orblendedsensorswithsensortrendingfunction

Rate Management SuddenBradyResponse(SBR),PMTTermination,PVARPafterPVC,DynamicPVARP

RA/RV Pace-Sense Configuration

Unipolar,Bipolar,Bipolar/Unipolar,Unipolar/Bipolar,Unipolar/Off,Bipolar/Off,LeadSafetySwitch,AutomaticLeadRecognition

*Models U225 and U226 only

Implant/In Clinic Follow UpImplant Communication Mode

Programmablevalues:EnableuseofZIP™telemetry(MICS)(RequiresinitialuseofwandfordeviceID)orusewandforalltelemetry

Nominal:EnableuseofZIP™telemetry(RequiresinitialuseofwandfordeviceID)

In Clinic Follow Up SnapshotFunctionupto12secondstraceofECG/EGMdisplaystored

POST(Post-OperativeSystemTest):providesanautomaticdevice/leadcheckatapre-determinedtimepost-implanttohelpdocumentpropersystemfunctionalitywithoutrequiringmanualsystemtesting

Indications-Based Programming (IBP)

Toolthatprovidesspecificprogrammingrecommendationsbasedonthepatient’sclinicalneedsandprimaryindications

Patient DiagnosticsArrhythmia Logbook EventSummary,StoredElectrogramswithAnnotation

Markers(Intervalsandapproximately14minutesallmultichannelEGM,alwayswith10secondsOnsetandeventstorageprioritization).ImplantactivationofallavailableEGMs.Onscreenmeasurementsofallstoredsignal,amplitudesandtiming.SnapshotFunction(upto12secondstraceofECG/EGMdisplaystored)

Histograms & Counters

VentricularTachyCounter,Brady/CRTCounter,Histograms,IntrinsicPromotion(RateHysteresis%successful)

HF Therapy / Diagnostics

HeartRateVariability(HRV)withSDANNandABM,RespiratoryRateTrend,APScan,AT/AFBurden,ActivityLevel,A&VArrhythmias,WeightandBloodPressure**

Atrial Arrythmia Report

AT/AF%andTotalTimeinAT/AF,AT/AFBurdenTrend,RVRateduringAT/AFTrend,PacingPercentTrend,HeartRateTrend,ActivityLevelandRespiratoryRateTrends,RVRateduringAT/AFHistogram.Timelinehistoryofinterrogations,programming,andcounterresetsforoneyear.LongestAT/AF,FastestRVSrateinAT/AF,andmostrecentepisode.

DAILY TREND for last 365 Days

Events,ActivityLevel,AT/AFBurden,PacingPercent,RespiratoryRate,APScan,HeartRate,SDANN,HRVFootprint,ABM,LeadImpedanceandAmplitude,RAATTrend,RVATTrend,LVATTrend

**Weight and Blood Pressure are only available via Latitude.

Remote Follow UpRemote Monitoring ThisdeviceisdesignedtobeLATITUDE™NXTenabled;

LATITUDE™NXTavailabilityvariesbyregion

Thresholds AutomaticstorageoflastsuccessfuldailyPaceSafethresholdtestforallactivechambers

Wireless Remotefollow-upforalldevices(MICS)

Patient Triggered Monitor (PTM)

Triggersthestorageoftwominutesonsetandoneminutepost–EGMs,intervals,andannotatedmarkerdataduringasymptomaticepisodebyplacingamagnetoverthedevice

Heart Failure TherapyHeart Failure Therapy Optimization

SmartDelay™(AVOptimization),BiVTrigger,LVOffset,LVSensing

LV Lead Options QuadripolarLVlead(VISIONISTX4CRT-P)

BipolarandUnipolarLVlead(VISIONISTCRT-P)

LV Pacing Vector Options

17options(VISIONISTX4CRT-P)

6options(VISIONISTCRT-P)

LV Sensing Vector Options

8optionsplusOFF(VISIONISTX4CRT-P)

5optionsplusOFF(VISIONISTCRT-P)

Safety Functions***

Safety Core Isintendedtoprovidelife-sustainingtherapyifcertainnon-recoverableorrepeatfaultconditionsoccur.SafetyCoreoperatesindependentlyandactsasabackuptothesecomponents

Electrocautery Protection Mode

ProvidesasynchronouspacingattheprogrammedoutputsandLRLwhencommandedbytheprogrammer

***The Safety Functions do not have programmable parameters.

www.bostonscientific.eu

ImageReady™ MR-Conditional Pacing SystemMRI Lead Selection MRConditionalPulseGeneratorU128andU228

combinedwith:

PacingLead:FINELINE™II,INGEVITY™

LVLead:ACUITY™X4

MRI Conditions 1.5Tand3T

Fullbody

MRI Mode PacingMode:AOO,VOO,DOO,Off

VentricularPacingChamber:BiV,RV-Only

ProtectionModeTimeOut:Off,3,6,9,12,24,48hours