VISIONIST X4 CRT-P and VISIONIST CRT-P - Boston Scientific › content › dam › bostonscientific...
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VISIONIST ™ X4 CRT-P and VISIONIST ™ CRT-P Models U225, U226, U228 • Provides an ImageReady ™ MR Conditional system* at 3T and 1.5T, full body, with no time limitations, with automatic MRI timeout feature to optimize workflow in the MR environment • Extended Longevity device projected to last up to 13.8 years** • The X4 CRT-P and ACUITY ™ X4 lead portfolio features: – electrodes on a 3D spiral designed to allow pacing from a basal location without sacrificing fixation or thresholds – 17 pacing options to manage phrenic nerve stimulation and high thresholds – multiple lead shapes with a 2.6F (0.86 mm) tapered lead tip to improve predictability of accessing target vessels • Advanced AF and HF diagnostic reports provide a comprehensive and proactive approach for comorbidity management • RF telemetry for wireless transmission of information and efficiency in the operating room and follow-up setting • Remote patient monitoring with the LATITUDE ™ NXT Patient Management System • RightRate ™ MV sensor is the only MV sensor clinically proven to restore chronotropic competence 1 • Enhanced features and diagnostics, including AP Scan ™ and Respiratory RateTrend, designed to provide you with greater insight into your patient’s disease progression based on the patient’s own respiration • POST function to facilitate patient follow up with a fully automatic device and lead check • EASYVIEW ™ header with port identifiers designed to make the implant experience more efficient *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 Specifications Size (cm) Connector Type Model Type (W x H x D) Mass (g) Volume (cc) (RA RV LV) U225 (non-MRI model) CRT-P 4.45 x 6.13 x 0.75 30.6 15.2 RA/RV/LV: IS1 U226 (non-MRI model) CRT-P 4.45 x 6.13 x 0.75 31.1 15.2 RA/RV: IS1 – LV:LV1 U228 X4 CRT-P 4.45 x 6.17 x 0.75 33.0 16.6 RA/RV: IS1 – LV:IS4 • Assumes 70 min-1 LRL, DDDR mode; 100% biventricular pacing; 15% atrium pacing and 0.4 ms pacing. PulseWidth (RA, RV, LV); RA Impedance 500 Ω; sensors On, EGM Onset On. These calculations also assume that the pulse generator spends 6 months in Storage mode during shipping and storage, the ZIP ™ telemetry use for 3 hours at implant time and for 40 minutes annually for in-clinic follow-up checks. • Power Supply: lithium-carbon monofluoride cell; Boston Scientific; 40229. Additional Longevity Information Longevity Projected Longevity RA/RV LV 500Ω 700Ω 700Ω, no MV/RS Typical programmed setting 2.5V 3.0V 10.3 11.2 11.7 Maximum labeled longevity 2.0V 2.0V 12.4 13.1 13.8
Transcript of VISIONIST X4 CRT-P and VISIONIST CRT-P - Boston Scientific › content › dam › bostonscientific...
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.
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CRM-251102-ACProducedbyGosling.
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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
