the amplatzer03 septal occluder.docx

the amplatzer03 septal occluder.docx

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theamplatzer03septaloccluder

TheAMPLATZER®SeptalOccluderandDeliverySystem

InstructionsforUse

TableofContents

SectionPage

1BriefDeviceDescription1

2Indications&Usage1

3Contraindications1

4Warnings2

5Precautions2

6AdverseEvents3

7ClinicalStudies5

8IndividualizationofTreatment9

9PatientInformation10

10HowSupplied10

11DirectionsforUse10

AMPLATZER®SeptalOccluderandDeliverySystem

Caution:

Federallaw（USA）restrictsthisdevicetosalebyorontheorderofaphysician（orproperlylicensedpractitioner）.

1.BRIEFDEVICEDESCRIPTION

TheAMPLATZERSeptalOccluderisaself-expandable,doublediscdevicemadefromaNitinolwiremesh.ThetwodiscsarelinkedtogetherbyashortconnectingwaistcorrespondingtothesizeoftheASD.Inordertoincreaseitsclosingability,thediscsandthewaistarefilledwithpolyesterpatches.Thepolyesterpatchesaresecurelysewntoeachdiscbyapolyesterthread.

TheAMPLATZERDeliverySystemwasdesignedspecificallytofacilitateattachment,loading,deliveryanddeploymentoftheAMPLATZERSeptalOccluderandiscomprisedofadeliverysheath,dilator,loadingdevice,plasticviseanddeliverycable.

2.INDICATIONSANDUSAGE

TheAMPLATZERSeptalOccluderisapercutaneous,transcatheter,atrialseptaldefectclosuredeviceintendedfortheocclusionofatrialseptaldefects（ASD）insecundumposition.PatientsindicatedforASDclosurehaveechocardiographicevidenceofostiumsecundumatrialseptaldefectandclinicalevidenceofrightventricularvolumeoverload（ie,1.5:

1degreeoflefttorightshuntorRVenlargement）orclinicalsymptomssuchasparadoxicalembolismoratrialdysrhythmiainthepresenceofaminimalshunt.

ThedeviceisalsoindicatedinthosepatientswhohaveundergoneafenestratedFontanprocedureandwhonowrequireclosureofthefenestration.

3.CONTRAINDICATIONS

3.1Anypatientknowntohaveextensivecongenitalcardiacanomalywhichcanonlybeadequatelyrepairedbywayofcardiacsurgery.

3.2Anypatientknowntohavelocalorgeneralizedsepsis,oranysystemicinfectionthatcannotbesuccessfullytreatedpriortodeviceplacement.

3.3Anypatientknowntohaveableedingdisorder,untreatedulceroranyothercontraindicationstoaspirintherapy,unlessanotheranti-plateletagentcanbeadministeredfor6months.

3.4Anypatientknowntohaveademonstratedintracardiacthrombionechocardiography（especiallyleftatrialorleftatrialappendagethrombi）.

3.5Anypatientwhosesizeorconditionwouldcausethepatienttobeapoorcandidateforcardiaccatheterization.

3.6Anypatientwherethemarginsofthedefectare<5mmtothecoronarysinus,AVvalvesandrightupperlobepulmonaryvein.

4.WARNINGS

4.1TheAMPLATZERSeptalOccluderandDeliverySystemshouldonlybeusedbythosephysicianstrainedintranscatheterdefectclosuretechniques.

4.2Physiciansmustbepreparedtodealwithurgentsituationswhichrequireremovalofembolizeddevicesthatresultincriticalhemodynamiccompromise.

4.3Embolizeddevicesmustberemoved.Embolizeddevicesshouldnotbewithdrawnthroughintracardiacstructuresunlesstheyhavebeenadequatelycollapsedwithinasheath.

4.4Donotuseifthesterilebarrierhasbeencompromisedinanyway.

5.PRECAUTIONS

5.1Handling

∙TheAMPLATZERSeptalOccluderandDeliverySystemareforsingleuseonly.Donotreuseorresterilize.

5.2Sizing

∙AccuratedefectsizingiscrucialtoAMPLATZERSeptalOccluderdeviceselection.Theuseofacompliantballooncathetertodeterminedefectsizeisrecommended.Deviceselectionshouldbeequalto,orslightlylargerthan,theballoonstretcheddiameterofthedefect.

5.3Procedural

∙Aspirin（3-5mg/kg/day）istobestartedatleast24hourspriortotheprocedure.Intherarecaseofaspirinintolerance,twotimes200mgofTiclopidinaregiven.Cephalosporintherapyisoptional.

∙Patientshouldfullyheparanizedthroughouttheprocedurewithaminimumactiveclottingtime（ACT）of200secondspriortodeviceinsertion.

∙Transesophogealechocardiography（TEE）orsimilarimagingequipmentisrecommendedasanaidinplacingtheAMPLATZERSeptalOccluder.Ifused,thepatient’sesophogealanatomymustbeadequateforplacementandmanipulationoftheTEEprobe.

∙DonotreleasetheAMPLATZERSeptalOccluderfromthedeliverycableifthedevicedoesnotconformtoitsoriginalconfigurationorifthedevicepositionisunstable.Recapturethedeviceandredeploy.Ifstillunsatisfactory,recapturethedeviceandreplacewithanewdevice.

5.4

Post-Implant

∙Patientsshouldtakeappropriateendocarditisprophylaxisfor6monthsfollowingdeviceimplantation.Thedecisiontocontinueendocarditisprophylaxisbeyond6monthsisatthediscretionofthephysician.

∙Patientsshouldbetreatedwithantiplatelet/anticoagulationtherapy（suchasaspirin）for6monthspostimplant.Thedecisiontocontinueantiplatelet/anticoagulationtherapybeyond6monthsisatthediscretionofthephysician.

6.ADVERSEEVENTS

6.1ClinicalSummary

TheAMPLATZERSeptalOccluderwasevaluatedinamulti-center,non-randomized,pivotalstudycomparingthedevicetosurgicalclosureofatrialseptaldefects;423patientsreceived433deviceswithatotaldeviceexposureof911.5years.Individualpatientexposuretothedeviceaveraged25.6months（rangingfrom0to38.9）.

ARegistrygroupwasalsostudiedtoevaluatethedeviceinpatientswithotherconditionsappropriatefordeviceclosure.Forty-eight（48）patientswithFenestratedFontan（communicationinthebafflewithatleast5mmdistancefromthefreeatrialwallandcentralvenouspressurelessthan15Hg）wereenrolledinthestudy.

6.2Deaths

TherewasonenondeviceorprocedurerelateddeathreportedinthepivotalstudyandnodeathswerereportedintheFenestratedFontanRegistryGroup.

6.3ObservedAdverseEvents

6.3.1PivotalClinicalStudy

Table1Complications–PivotalStudy

MajorComplication

AMPLATZER

Patients

SurgicalControl

Patients

p-value

CardiacArrhythmiarequiringmajortreatment

2/442（0.5%）

0/154（0.0%）

1.00

DeviceEmbolizationwithsurgicalremoval

3/442（0.7%）

0/154（0.0%）

0.57

DeviceEmbolizationwithpercutaneousremoval

1/442（0.2%）

0/154（0.0%）

1.00

DeliverySystemFailure

1/442（0.2%）

0/154（0.0%）

1.00

PericardialEffusionwithtamponade

0/442（0.0%）

3/154（1.9%）

0.017

PulmonaryEdema

0/442（0.0%）

1/154（0.6%）

0.26

RepeatSurgery

0/442（0.0%）

2/154（1.3%）

0.066

SurgicalWoundComplication

0/442（0.0%）

2/154（1.3%）

0.066

TotalMajorComplicationsPatients

7/442（1.6%）

8/154（5.2%）

0.030

Table1Complications–PivotalStudy（continued）

MinorComplications

AMPLATZER

Patients

SurgicalControl

Patients

p-value

Anemia

0/442（0.0%）

1/154（0.6%）

0.26

Allergicreaction（drug）

2/442（0.5%）

0/154（0.0%）

1.00

Atelectasis

0/442（0.0%）

1/154（0.6%）

0.26

CardiacArrhythmiasMinorTreatment

15/442（3.4%）

9/154（5.8%）

0.23

DeviceEmbolizationwithpercutaneousremoval

1/442（0.2%）

0/154（0.0%）

1.00

ExtremityTingling/Numbness

1/442（0.2%）

0/154（0.0%）

1.00

Headaches/PossibleTIA

2/442（0.5%）

0/154（0.0%）

1.00

DeliverySystemFailure

2/442（0.5%）

0/154（0.0%）

1.00

PericardiotomySyndrome

0/442（0.0%）

2/154（1.3%）

0.066

Pericardialeffusion

0/442（0.0%

6/154（3.9%）

<0.001

PleuralEffusion

0/442（0.0%）

1/154（0.6%）

0.26

Pneumothorax

0/442（0.0%）

3/154（1.9%）

0.017

StaphInfection

0/442（0.0%）

1/154（0.6%）

0.26

SurgicalWoundComplications

0/442（0.0%）

1/154（0.6%）

0.26

Thrombusformation

3/442（0.7%）

0/154（0.0%）

0.56

Transfusions

0/442（0.0%）

2/154（1.3%）

0.066

UpperRespiratoryInfection/Fever

0/442（0.0%）

2/154（1.3%）

0.066

UrinaryTractDisturbance

1/424（0.2%）

0/154（0.0%）

1.00

TotalMinorComplications（Patients）

27/442（6.1%）

29/154（18.8%）

<0.001

6.3.2RegistryGroup–FenestratedFontan

Table2:

Complications-FF

AMPLATZER

Patients

Upper95%Confidence

Bound

MajorComplication

RepeatSurgery

1/48（2.1%）

0.095

Hemothorax

1/48（2.1%）

0.095

MinorComplication

Vomiting（required2nightsinhospital）

1/48（2.1%）

0.095

Atrialfibrillation/cardioversion

1/48（2.1%）

0.095

TotalComplications

4/48（8.3%）

0.181

6.4PotentialAdverseEvents

PlacementoftheAMPLATZERSeptalOccluderinvolvesusingstandardinterventionalcardiaccatheterizationtechniques.Thefollowingadverseevents（listedinalphabeticalorder）mightbeexpectedfrominterventionalcardiaccatheterizationtechniques.

∙Airembolus

∙Allergicdyereaction

∙Anesthesiareactions

∙Apnea

∙Fever

∙Hypertension/hypotension

∙Infectionincludingendocarditis

∙Perforationofvesselormyocardium

∙Pseudoaneurysmincludingbloodlossrequiringtransfusion

∙Valvularregurgitation

7CLINICALSTUDIES

TheAMPLATZERSeptalOccluderwasevaluatedinamulti-center,non-randomizedcontrolledstudytocomparetheclinicalperformanceofthedeviceforASDclosurewiththatdocumentedfortheASDSurgicalrepairprocedure.Additionally,thedevicewasstudiedinpatientswithuncommonconditionswhereintranscatheterclosurewiththedevicemayalsobebeneficial（RegistryGroup）.

7.1PatientsStudied

7.1.1Pivotalstudy–AtrialSeptalDefects

Attempttotreatwasinitiatedin442devicepatientsand154surgicalpatients.Enrolledpatientshadechocardiographicevidenceofostiumsecundumatrialseptaldefect（devicegroup:

defectsize<38mm）andclinicalevidenceofrightventricularvolumeoverloadorhadclinicalsymptomssuchasparadoxicalembolismoratrialdysrhythmiainthepresenceofaminimalshunt.Exclusioncriteriaincluded:

∙Patientswithmultipledefectsthatcouldn