FDA批准Abiomed微型血泵Impella2.5System

2015年3月25日讯/生物谷BIOON/--美国食品和药物管理局（FDA）近日批准了美国Abiomed公司研发的一款微型血泵Impella2.5System，用于正在开展高风险经皮冠状动脉介入手术（HRPCI，如球囊血管成形术及支架植入术）的特定冠状动脉疾病（CAD）患者，以帮助维持其心跳功能和血液循环。Impella2.5System微型血泵是FDA批准的首个用于高风险PCI时提供血流动力学支持的设备。
在整个高风险PCI手术过程中，Impella2.5System通过从左心室抽血并将血液泵入主动脉。在开展手术前，介入心脏病学家利用微创手术在腹股沟大动脉开一小口，将Impella2.5置于引导导管前端并通过导管将设备置入患者的左心室，一旦到位，外部控制器和监视器将开启或关闭泵，监测心脏功能，使医生能够调整泵以维持稳定的心脏功能和血液循环。
冠状动脉疾病（CAD）可导致胸痛和心脏发作，该病也是导致美国男女性死亡的主要原因。CAD发生于心脏表面某个或多个主要动脉变得狭窄或阻塞之时，导致供向心脏肌肉的富氧血液的流量减少。
Impella2.5System是一种微型心脏泵，适应症为临床用于正在进行HRPCI手术、具有严重症状性CAD且心脏功能减弱（但稳定）的患者。该设备不适用于正接受冠状动脉搭桥术的患者。Impella2.5System由美国马萨诸塞州的Abiomed公司研发。今年1月，该公司研发的另一款心脏泵ImpellaRP获批，该设备是FDA批准的首个经皮右心室辅助装置。
英文原文：FDAapprovesbloodpumpsystemtohelppatientsmaintainstableheartfunctionduringcertainhigh-riskcardiacprocedures
Systemintendedforcertainpatientsundergoingtreatmentforseverecoronaryarterydisease
TheU.S.FoodandDrugAdministrationtodayapprovedtheImpella2.5System,aminiaturebloodpumpsystemintendedtohelpcertainpatientsmaintainstableheartfunctionandcirculationduringcertainhigh-riskpercutaneouscoronaryintervention(HRPCI)procedures,suchasballoonangioplastyandstenting,whichre-opencoronaryarteriesthatarenarrowedorblockedduetoseverecoronaryarterydisease(CAD).CoronaryarterydiseasecanleadtochestpainandheartattackandistheleadingcauseofdeathforbothmenandwomenintheU.S.Itoccurswhenoneormoreofthemajorarteriesonthesurfaceoftheheartbecomenarroworblocked,reducingbloodflowthatsuppliestheheartmusclewithoxygen-richblood.
TheImpella2.5SystemisaheartpumpintendedfortemporaryusebypatientswithseveresymptomaticCADanddiminished(butstable)heartfunctionwhoareundergoingHRPCIbutarenotcandidatesforsurgicalcoronarybypasstreatment.Inpatientswithdiminishedheartfunction,theheartpumpslessbloodthannormaleverytimeitbeats,whichissometimesassociatedwithCAD.
ThroughoutanHRPCIprocedure,theImpella2.5Systemhelpsmaintainstableheartfunctionbydrawingbloodfromtheleftlowerchamberoftheheart(leftventricle)andpumpingitintotheaorta,themainbloodvesselleadingawayfromtheheartthatsuppliesoxygen-richbloodtothebody.Priortostartingaprocedure,theinterventionalcardiologistplacestheImpella2.5usingacatheter(alongnarrowtube)withthepumploadedintothetip.Theheartisaccessedbyinsertingthecatheterintooneofthebody’slargearteries,usuallyintheleg,andthenguidingthetipofthecatheterthroughthepatient’sarteriesandintotheleftventricle.Onceinplace,anexternalcontrollerandmonitorturnsthepumponandoff,measuresheartfunction,andallowshealthcareproviderstoadjustthepumpasnecessarytomaintainstableheartfunctionandcirculationduringtheprocedure.
AllpatientsundergoingHRPCIareatsomeriskforcomplicationsrelatedtodecreasedheartfunctionandloweredbloodpressureduringtheprocedure,butpatientsinneedoftreatmentforextensiveorcriticallylocatedCADwhoarealreadyexperiencingdiminishedheartfunctionareathighrisk.UnstableheartfunctionthatoccursduringperformanceofanHRPCIprocedurecanresultinseriouscomplicationsorpreventcompletionoftheprocedure.
“UseoftheImpella2.5Systemisintendedtopreventepisodesofunstableheartfunction,includingunstablebloodpressureandpoorcirculation,inpatientswhoareathighriskforitsoccurrence,”saidWilliamMaisel,M.D.,M.P.H.,actingdirectoroftheOfficeofDeviceEvaluationintheFDA’sCenterforDevicesandRadiologicalHealth.
TheFDArevieweddatafortheImpella2.5Systeminapremarketapprovalapplication,theagency’spathwaytoevaluateareasonableassuranceofsafetyandeffectivenessforclassIIImedicaldevices.DatasupportingtheapprovaloftheImpella2.5Systemincludedclinicaldatafromthemanufacturer’sPROTECTIIclinicalstudywithsupportinginformationobtainedfromtheUSpellaRegistry,amulti-center,observationalregistry.
Theoveralldataprovidedevidencethat,forpatientswithsevereCADanddiminishedheartfunction,thetemporarycirculatorysupportprovidedbytheImpella2.5SystemduringaHRPCIproceduremayallowalongerandmorethoroughprocedurebypreventingepisodesofhemodynamicinstability(e.g.,poorcirculation,lowbloodpressure)duetotemporaryabnormalitiesinheartfunction.Moreover,fewerlateradverseevents(e.g.,needforrepeatHRPCIprocedures)mayoccurinpatientsundergoingHRCPIwiththepumpcomparedtopatientsundergoingHRPCIwithanintra-aorticballoonpump(IABP).TheImpella2.5SystemcanbeusedasanalternativetotheIABPwithoutsignificantlyincreasingthesafetyrisksoftheHRPCIprocedure.
TheImpella2.5SystemismanufacturedbyAbiomed,Inc.,basedinDanvers,Massachusetts.
TheFDA,anagencywithintheU.S.DepartmentofHealthandHumanServices,protectsthepublichealthbyassuringthesafety,effectiveness,andsecurityofhumanandveterinarydrugs,vaccinesandotherbiologicalproductsforhumanuse,andmedicaldevices.Theagencyalsoisresponsibleforthesafetyandsecurityofournation’sfoodsupply,cosmetics,dietarysupplements,productsthatgiveoffelectronicradiation,andforregulatingtobaccoproducts.
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