Closing Remarks Newsletter - Summer 2009 - Gore Medical

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Gore Continues Commitment to Stroke Therapy...continued from page 1family of endovascular products. TheGORE HELEX Septal Occluder is currentlybeing investigated within a randomizedclinical trial (Gore REDUCE ClinicalStudy * ) to assess the reduction ofrecurrent cryptogenic stroke in patientswith patent foramen ovale (PFO). Gore isalso focused on interventional therapiesfor carotid artery disease, beginningwith the development of a unique neuroprotection platform for use duringcarotid artery angioplasty and stenting.Figure 1: GORE Flow Reversal System, continuouslydirects macro and micro emboli away fromthe brain during flow reversal.To date, CEA is considered the standardof care for carotid revascularization, butcarotid artery stenting (CAS) is becomingmore of an alternative to surgery. Datashowing that CEA produces fewerperiprocedural embolic events than CASindicates one area where the proceduralsafety profile of CAS can be improved 3,4 .The most commonly used type of neuroprotection devices are filters, whichare positioned distal to the lesion priorto stenting. Distal filters have knownlimitations, such as requiring to betracked though the target lesion inorder for protection to be established,which increases the risk of generatingemboli. In addition, the filter porosityneeded to allow for antegrade flowand / or sub-optimal wall appositionmay result in micro emboli beingreleased to the neurovasculature.Moreover, distal internal carotid artery(ICA) vessel tortuosity may impedeproper placement of the filter andoverfilling of the filter with embolicdebris may result in slow blood flow,potential patient intolerance, and therelease of debris during filter retrieval.Gore is focused on the developmentof technologies thatpromise to reduceor eliminate thesesources of periproceduralembolic riskduring CAS.The GOREFlow ReversalSystem is aunique embolicprotection systemthat operates on theprinciple of reversing theflow of blood at the treatment site. Theconcept that flow reversal could be usedto provide cerebral protection duringCAS was developed by Juan Parodi,MD in collaboration with Mark Bates,MD, Claudio Schönholz, MD, and TakOhki, MD. Flow reversal is achieved bytemporarily occluding antegrade bloodflow in the common carotid and externalcarotid artery, similar in many ways toclamping during CEA. By establishinga shunt between the carotid artery andfemoral vein, blood from the collateralvessels is redirected to the lowerpressure venous return, resulting in flowreversal at the treatment site. Redirectedblood is filtered outside the body beforebeing reintroduced into the venoussystem (Figure 1). With flow reversalestablished, the GORE Flow ReversalSystem continuously directs both macroand micro emboli away from the brain,minimizing the risk of emboli reachingthe brain throughout critical stages ofthe CAS procedure. Because the systemis positioned proximal to the targetlesion, protection is established beforeinteracting with the lesion, minimizingthe risk of emboli being generated whileestablishing protection. In addition,use of the GORE Flow Reversal Systemeliminates concerns about distal vesseltortuosity and finding a suitable landingzone for a distal filter, and allows thephysician to use their guidewire ofchoice.Successful use of the original flowreversal device was reported in severalseries, including a 200 patient studythat reported a perioperative strokeand death rate of 1.5% 5 . In the GoreEMPiRE Clinical Study ** the safety andefficacy of the GORE Flow ReversalSystem during CAS was assessed inpatients at high risk for CEA. Twentynine(29) US sites participated in thestudy and enrolled 245 pivotal subjectsbetween July 2006 and July 2008. Thepatient population treated included32% symptomatic patients and 16%octogenerian patients. The primarystudy endpoint Major Adverse Events(MAE) was a composite of death,stroke, transient ischemic attack (TIA),
or myocardial infarction (MI) throughthe 30-day post-procedure follow-up.The MAE rate for the study was 4.5%.The 30-day stroke, death, and MI ratewas 3.7% and the death / any strokerate was 2.9%. Importantly, the studyalso showed 0% major ischemic stroke.The results in some of the historicallymost challenging patient populationsfor CAS were encouraging with a lowdeath, stroke, and MI rate of 2.6% foroctogenarians and 3.8% for symptomaticpatients. The death / any stroke rate forsymptomatic and asymptomatic patientsin this study was also low at 2.6% and3.0%, respectively. The Gore EMPiREClinical Study is one of the first carotidartery stenting studies that reporteddeath / stroke rates that are within theAmerican Heart Association guidelinesfor CEA of 3% for asymptomatic patientsand 6% for symptomatic patients 6 . TheGORE Flow Reversal System received FDAclearance on February 4, 2009.In addition to the GORE Flow ReversalSystem, Gore has developed a distalfilter that is designed to limit the escapeof debris between the filter and thevessel wall, with enhanced vessel wallapposition, and circumferential supportof the filter media (Figure 2). In vitrotesting showed that the GORE EmbolicFilter performs well in straight anatomyand maintains its performance inrepresentative tortuous anatomy (Figure3). The GORE Embolic Filter is currentlybeing studied in an IDE trial in the US inthe Gore EMBOLDEN Clinical Study *** .With a nearly 30 year history indeveloping and bringing products tomarket that prevent stroke, Gore hasshown a continuing commitment toproviding physicians with tools thatDiamond FrameCircumferential FilterAttachmentConformable HeparinCoated ePTFE Media with100 micron PoresFigure 2 GORE Embolic Filter, designedto improve filter efficiency.improve patient outcomes. Withpromising data for the GORE FlowReversal System and initiation of a studyevaluating the GORE Embolic Filter andGORE HELEX Septal Occluder, Gore iscommitted to raising the bar for strokeprevention and future therapies.In Vitro Filter Efficiency Evaluations AFilter Efficiency (%)100908070605040DeviceStraight20 mm CurveTest ConfigurationFigure 3 The GORE Embolic Filter not only performswell in GORE straight Embolic vessels, FIlter but ACCUNET also maintainsDeviceperformanceFILTERWIREwhen deployedEZ DeviceinANGIOGUARDtight curves thatSpideRXDeviceare representative of tortuous clinical anatomy.Embro Sheild ProCaution: GORE Embolic Filter is an InvestigationalDevice. Limited by United States Law toInvestigational Use.nPoreSize(microns)ParticleSize(microns)GORE Embolic Filter 72 100 116FILTERWIRE EZ Device 8 110 116RX ACCUNET ® Device 4 120 143ANGIOGUARD RX Device 4 100 116SPIDERX Device 4 50 – 300 B 240EmboShield PRO Device 3 120 143A Data on FileB Karnabatidis D, Katsanos K, Kagadis GC, et al.Distal embolism during percutaneousrevascularization of infra-aortic arterial occlusive disease: an underestimatedphenomenon. Journal of Endovascular Therapy 2006;13(3):269-280.Gore has prepared a specialCD that discusses the GOREFlow Reversal System. For acopy of the CD, please e-mailClosingRemarks@wlgore.com.*REDUCE: GORE HELEX Septal Occluder andAntiplatelet Medical Management for Reductionof Recurrent Stroke or Imaging-Confirmed TIA inPatients with Patent Foramen Ovale (PFO)**EMPIRE: Embolic Protection with ReverseFlow Study of the GORE Flow Reversal Systemin Carotid Stenting of Subjects at High Risk forCarotid Endarterectomy***EMBOLDEN: GORE Embolic Filter in CarotidStenting for High Risk Surgical SubjectsREFERENCES1.World Health Organization. Global burden of stroke.http://www.who.int/cardiovascular_diseases/en/cvd_atlas_15_burden_stroke.pdf Accessed August 18,2009.2.Lloyd-Jones D, Adams R, Carnethon M, et al; AmericanHeart Association Statistics Committee and StrokeStatistics Subcommittee. Heart disease and strokestatistics-2009 update: a report from the AmericanHeart Association Statistics Committee and StrokeStatistics Subcommittee. Circulation 2009;119(3):480-486.3.Gossetti B, Gattuso R, Irace L, et al. Embolism tothe brain during carotid stenting and surgery. ActaChirurgica Belgica 2007;107(2):151-154 .4.Flach HZ, Ouhlous M, Hendriks JM, et al. Cerebralischemia after carotid intervention. Journal ofEndovascular Therapy 2004;11(3):251-257.5.Parodi JC, Schönholz C, Parodi FE, Sicard G, FerreiraLM. Initial 200 cases of carotid artery stenting usingreversal-of-flow cerebral protection device. Journal ofCardiovascular Surgery 2007;48(2):117-124.6.Hopkins LN Clair D; EMPiRE Investigators. EMPiRE:A multicenter registry evaluating neuroprotectionduring carotid stenting with a novel flow reversalsystem. Presented at the TCT 2008: TranscatheterCardiovascular Therapeutics 20th Annual ScientificSymposium; October 12 -17, 2008; Washington, DC.
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Closing Remarks Newsletter - Summer 2009 - Gore Medical

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