Active-Fixation lead Model 5086

CapSureFix MRI™ENGINEERED WITH SURESCAN MRI™ TECHNOLOGY

www.mrisurescan.com www.mrisurescan.com

Modern pacing systems are not safe for MRI

• TheAmericanCollegeofRadiology(ACR)andtheRadiologicalSocietyofNorthAmerica(RSNA)warnthatmedicaldevicesmaymalfunctionorcauseproblemsduringanMRIexam1

• ContraindicationsagainstMRIscansforpeoplewithimplantablecardiacdevicesarefoundonthewebsitesofallthemainmanufacturersofimplantablecardiacdevices2-6

• PatientsareatriskofserioussideeffectsordeathintheabsenceofapacingsystemapprovedforMRIuse7-10

What are the patient risks specific from the lead?• Thelead,whenexposedtotheextensiveradiofrequency(RF)energyandgradientmagneticfieldintheMRImachine,canbe

asourceofrisktothepatient.

• ThepulseRFfieldappliedontheleadcanmakeitbehaveasanantennaandtheenergyisdissipatedtothetip,heatingtheleadtipwhichcandamagethetissue.

How did Medtronic counteract MRI risk with the 5086 CapSureFix MRI™ lead?Start with a well established designThe5086isbasedon5076CapSureFixNovus®design.- TitaniumNitride(TiN)coatedelectrodes,toprovidelowtip-to-tissuepolarization.- MED-4719siliconeinnerandouterinsulationforimprovedcrush-resistanceproperty.- Short10mmtip-to-ringspacingtoreducefar-fieldsensingwhenusedintheatrium.

Over2millions5076leadshavebeenimplantedworldwidewith99%longtermsurvivabilityrate overthepast8years11.

Safe by design, not by chance• Exhaustiveresearchandrigoroustestingledtoa5086innercoilgeometryredesignedto

reducetransferofinducedenergy.

Is there a pacing system with proven safety in the MRI environment?• TheSureScan™pacingsystem,consistingofthepacemakerandleads,whenusedtogether,allowspatients

tosafelyundergoMRIscansundercertainconditions.

• Aclinicalstudyofmorethan450patientsconfirmedthesafetyandperformanceoftheSureScan pacingsystem12.

• It’sthefirstpacingsystemtoreceiveCEmarkapprovalforuseinMRI.

Leadtip

Helix

Microscopic view of histologic tissue damage due to lead tip heating in MRI (canine). Blue: scar tissue. Pink: viable tissue.

5076 and 5086 lead bodies

5076 5086 MRI

• Inducedenergycanalsoresultincapture,deliveringunintendedpacing.

Gradient Field Induced VT

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EuropeMedtronicInternationalTradingSàrlRouteduMolliau31CasepostaleCH-1131Tolochenazwww.medtronic.euTel:+41(0)218027000Fax:+41(0)218027900

United Kingdom/IrelandMedtronicLimitedBuilding9CroxleyGreenBusinessParkHattersLaneWatfordHertsWD188WWwww.medtronic.co.ukTel:+44(0)1923212213Fax:+44(0)1923241004

www.medtronic.eu

Implanting the 5086 leadGeneral considerations for active leads fixation- Donotdirectdriveleadwithfullyseatedstyletintoresistivecardiacstructures.- Numberofpinconnectorrotationsforhelixextensioncanvarybasedonthelead

pathinthebody.- Expectmorerotationsintortuousanatomy.- Fluoroscopy is the only reliable confirmation of helix extension.- Donotgivetheleadbodyoneturnpostfixation.

Consideration specific to 5086 (compared to other CapSureFix Novus® leads)- Handlingofthe5086iscomparabletootherMedtronicactiveleads12withsome

differencesprimarilyinstiffnessandtorquetransferduetoit’suniquedesign13.- 5086willrequiremorepinconnectorrotationstoextendthehelix.- OnX-Ray,radiopaqueiconidentifiesaSureScanlead.

SpecificationsType Bipolar

Fixation Screw-in

MaterialsConductor MP35Nnickelalloy

Insulation Treatedsiliconerubber

Electrode (Helix/ring)materials

Titaniumnitridecoatedplatinumalloy

Tiptoringspacing 10mm

DiameterLeadbody 2.3mm

Leadintroducer (recommendedsize)

withoutguidewire:2.7mm(8French)withguidewire:3.7mm(11French)

Lengths 45,52,58cm

Connector IS-1BI

Watch Fluoroscopy for helix extension:

Helix extended

Helix retracted

Brief Statement Seethedevicemanualfordetailedinformationregardingtheimplantprocedure,indications,contraindications,warnings,precautions,andpotentialadverseevents.

References1 MedtronicInc.Dataonfile.2 RadiologyInfo(tm)-ThepublicinformationwebsitedevelopedandfundedbytheAmericanCollegeofRadiology(ACR)andtheRadiologicalSocietyofNorthAmerica(RSNA).http://www.radiologyinfo.org/en/info.cfm?pg=bodymr#part_nine.AccessedMay7,2009.

3 BostonScientific.http://www.bostonscientific.com.AccessedMay7,2009.4 St.JudeMedical.http://www.sjm.com.AccessedMay7,2009.5 Medtronic,Inc.http://www.medtronic.com.AccessedMay7,2009.6 Biotronik.http://www.biotronik.com.AccessedJuly30,2009.7 MAUDEdatabase.8 GimbelJR.Unexpectedasystoleduring3Tmagneticresonanceimagingofapacemaker-dependent

patientwitha‘modern’pacemaker.Europace.2009Jun25.[Epubaheadofprint]9 IrnichWetal.Doweneedpacemakersresistanttomagneticresonanceimaging?Europace.2005Jul;7(4):353-65.

10HIBassen,GMendoza.In-vitromappingofEfieldsinducednearpacemakerleadsbysimulatedMR gradientfields.BioMedicalEngineeringOnLine2009,8:39.11Medtronicproductperformancereport.12EnRhythmMRISureScanPacingSystemClinicalStudy.13Forleo,G.B.etal.SafetyandefficacyofanewMRIcompatiblepacingsystem:earlyresultsofaprospectivecomparisonwithconventionaldual-chamberimplantoutcomes,HeartRhythm(2009),doi:10.1016/j.hrthm.2010.02.020.

PhotosusedwiththekindpermissionofSiemensAG.

SureScan™. The world’s first pacing systems designed, tested and approved for MRI