VitaFlow Aortic Valve

1.ProductIntroduction2.CaseReport3.1-YearClinicalOutcomesVitaFlowTMTranscatheterAorticValveSystemVitaFlowTMAorticValveVitaFlowTMDeliverySystemBalloonCatheterIntroducerSetVitaFlowTMAorticValve2SizeΦ21mm24mm27mm30mmAorticAnnulusDiameter17-20mm20-23mm23-26mm26-29mmHeightH50mm50mm53mm53mmHSkirt12mmSizeΦLowDensityCellsFlexibledesignforbetteralignmentduringdeploymentHighRadialForceDesignedforexpandingcalcifiedleafletsInnerandouterskirtDesignedforbettersealingandreducingPVLLargeCellsEnablecoronaryaccessSelf-expandingnitinolframeBovinepericardialleafletsPETskirtVitaFlowTMDeliverySystemMotorizedHandleEasytouse,allowforeasywiremanipulationduringdeploymentReinforcedInner/OuterShaftDesignedforstableandaccuratedeploymentManualhandleforback-upLowDeliveryProfile16/18FvalvecapsuleBalloonCatheterIntroducerSetValveAccessories4•KinkResistance•LowProfile,forVesselComplicationsReduction•Broadchoicewith11configurations•Lowcompliantballoonforaccuratesizing•Fastinflation/deflation•DiameterAvailability:8mmto28mm51.ProductIntroduction2.CaseReport3.1-YearClinicalOutcomesStudyDesign7ObjectiveDesignPrimaryEndpointSecondaryEndpointToevaluatethesafetyandeffectivenessofVitaFlowTMValveanddeliverysystemfor(TAVI)insymptomaticpatientswithseverecalcificaorticstenosis,whoareconsideredunsuitableforSurgicalValveReplacement.Prospective,multi-center,single-armtrialEnroll110patientsAllpatientswillbefollowedupat30days,6months,12months,and2-5yearspostTAVIAllcausemortalityat12monthsDevicesuccess,Proceduresuccess,MajorStroke,Valveperformance,Improvementofheartfunction,MACCE,Improvementoflifequality,etc.StudyDesign8KeyInclusionCriteriaAge≥70yearsoldDocumentedseverecalcifiednativeaorticstenosis(byEcho)EitherMeanpressuregradient≥40mmHg,orjetvelocity≥4.0m/s,oraorticvalvearea(AVA)1.0cm2(orAVAindex＜0.6cm2/m2)SymptomaticaorticvalvestenosiswithNYHAClass≥IILifeexpectancy＞12monthsPatientsdeemedtobesuitableforTAVIanatomicallyUnsuitableforSurgicalValveReplacementasevaluatedbytheheartteamConsentfrompatientsStudyAdministration&CasesEnrollment9Beijing•PekingUniversityFirstHospital•FuwaiHospital•ChinesePLAGeneralHospitalShenyang•TheGenralHospitalofShenyangMilitaryShanghai•ZhongshanHospital,FudanUniversity•RenjiHospital•RuijinHospitalHangzhou•ThesecondAffiliatedHospitalofZhejiangUniverstiySchoolofMedicineChengdu•WestChina,SichuanUniversityWuhan•WuhanAsiaHeartHospitalNanjing•NanjingDrumTowerHospitalPrincipalInvestigatorGeJunbo,MDIndependentClinicalEventsCommitteeCTCoreLaboratoryDr.NicoloPiazzaBaselineCharacters10CharacteristicN=110CharacteristicN=110Age–Year77.73±4.78COPD24/110MaleSex60/110LiverDisease3/110STSScore8.84RenalInsufficiency14/110CoronaryArteryDisease62/110DiabetesMellitus31/110Hypertension59/110CerebralVascularDisease22/110PreviousMyocardialInfarction6/110BicuspidAorticValveNon-bicuspidAorticValve42/11068/110PreviousPCI14/110LVEF57.22±12.00PeripheralVascularDisease45/110EffectiveOrificeArea–cm20.64±0.19AnginaCCSClassesII-IV20/110MeanAVGradient-mmHg60.41±19.40PreviousCABG0/110Approach&Size1194%1%5%ApproachTransfemoralAscendingAortaCarotidArteryImplantedValveSize58%7%5%30%21mm24mm27mm30mmClinicalOutcomes12ClinicalOutcomesDischarge,%N=11030-Day,%N=1106-Month,%N=1101-Year,%N=110All-causeMortality0.9%(1)0.9%(1)2.7%(3)2.7%(3)CardiovascularMortality1.8%(2)1.8%(2)1.8%(2)1.8%(2)AllStroke(Major&Minor)1.8%(2)2.7%(3)4.5%(5)4.5%(5)MajorVascularComplication1.8%(2)1.8%(2)1.8%(2)2.7%(3)CoronaryArteryObstruction1.8%(2)1.8%(2)1.8%(2)1.8%(2)NewPacemakerImplantation15.5%(17)*16.4%(18)*19.1%(21)*19.1%(21)**5.5%(6)patientswithI°AVBHemodynamicOutcomes60.418.7112.3811.1710.569.80.641.811.811.751.851.8300.511.522.50102030405060708090BaselineN=110Post-ProceduralN=110DischargeN=10930DaysN=1086MonthsN=10212MonthsN=105EffectiveOrificeArea(cm²）MeanAorticGradient(mmHg)MeanAorticGradient(mmHg)EffectiveOrificeArea(cm²）14ParavalvularLeak71%72%71%71%27%26%29%29%2%2%0%10%20%30%40%50%60%70%80%90%100%DischargeN=11030-DayN=1086-MonthN=10212-MonthN=105None/TraceMildModerateSevereNomoderateorseverePVLat12months.NYHACLASS6%27%47%71%19%44%56%48%26%59%42%16%4%2%22%8%1%1%1%0%20%40%60%80%100%BaselineN=110DischargeN=10830DaysN=1096MonthsN=10612MonthsN=107ClassIVClassIIIClassIIClassI710.37.15.28.846.70%24.30%4.20%7.40%2.70%3.40%4.30%3.40%2.30%00.00%5.00%10.00%15.00%20.00%25.00%30.00%024681012EvolutR(CEMark)CorevalvePivotalTrialLotusRepriseIIPartnerIIS3iTrialVitaFlowSTSScoreAll-causeMortalityMajorStroke1-YearOutcomesComparisonRef:PopmaJJ,M.D.,AdamsHD,etal.TranscatherterAorticValveReplacementUsingaSelf-expandingBio-prosthesisinPatientswithSevereAorticStenosisatExtremeRiskforSurgery.JACCVol.2014;63(19):1972-81,LeonMB,M.D.,SmithCR,etal.TranscatherterAortic-ValveImplantationforAorticStenosisinPatientsWhoCannotUndergoSurgery.NEnglJMed2010;363(17):1598-607MeredithAM,MBBS,PhD,DarrenL,etal.TranscatherterAorticValveReplacementforSevereSymptomaticAorticStenosisUsingaRepositionableValveSystem.JACCVol.2014;64(13):1339-48CoreValveEvolut-RCEStudy.PresentedattheTCTAnnualMeetingOct.13,2015;BaselineCharacters