Carotid WALLSTENT®

Monorail® Endoprosthesis Carotid WALLSTENT®

Monorail® Endoprosthesis

Deliverable ClosedCell Design

BEACHTRIALTrial Design: Multi-center, prospective, single-arm study.N=747, Roll-In Group N=189, Bilateral Group N=78, PivotalGroup N=480 (symptomatic ≥50% stenosis N=112;asymptomatic ≥80% stenosis N=368). 47 U.S. clinical sitesparticipated in the study.Trial Objective:To evaluate the outcomes of patients withcarotid artery stenosis at high risk for carotidendarterectomy (CEA) using the Carotid WALLSTENTMonorail Endoprosthesis and the FilterWire EX® andFilterWire EZ™ Embolic Protection Systems.

One-Year Morbidity and Mortality:•Non-Q-wave myocardial infarction within the 24 hoursfollowing carotid stenting

•Peri-procedural (≤30 days) death, stroke, Q-wavemyocardial infarction

•Late ipsilateral stroke or death due to neurologic eventsfrom 31 days up to and including 12-month follow-up

Peri-Procedural Morbidity and Mortality:•Non-Q-wave MI through 24 hours post procedure anddeath, stroke and Q-wave MI through 30 days postprocedure

CAROTIDWALLSTENT® MONORAIL® ENDOPROSTHESISINDICATIONS:The Carotid WALLSTENT Monorail Endoprosthesis (CarotidWALLSTENT Endoprosthesis), used in conjunction with the Boston Scientificembolic protection system, is indicated for the treatment of patients at high riskfor adverse events from carotid endarterectomy due to either anatomic orcomorbid conditions who require carotid revascularization in the treatment ofipsilateral or bilateral carotid artery disease and meet the following criteria:• Patients with neurological symptoms and ≥50% stenosis of the common, internalcarotid artery and/or the bifurcation by ultrasound or angiogram OR patientswithout neurological symptoms and ≥80% stenosis of the common, internalcarotid artery and/or the bifurcation by ultrasound or angiogram, AND • Patientswith a reference vessel diameter within the range of 4.0mm and 9.0mm at thetarget lesion.CONTRAINDICATIONS:The Carotid WALLSTENT Endoprosthesis iscontraindicated for use in: • Patients in whom anticoagulant and/or antiplatelettherapy is contraindicated • Patients with severe vascular tortuosity or anatomythat would preclude the safe introduction of a guide catheter, sheath, embolicprotection system or stent system • Patients with uncorrected bleeding disorders• Lesions in the ostium of the common carotid artery.GENERALWARNINGS: Refer to the Directions for Use supplied with anyinterventional devices to be used in conjunction with the Carotid WALLSTENTEndoprosthesis for their intended uses, contraindications and potentialcomplications. •The safety and efficacy of the Carotid WALLSTENT Endoprosthesishave not been demonstrated with embolic protection devices other than theFilterWire EZ™ System. • Risk of distal embolization may be higher if the CarotidWALLSTENT Endoprosthesis cannot be used in conjunction with an embolicprotection system during the carotid stenting procedure. •The long-termperformance of the Carotid WALLSTENT Endoprosthesis has not been established.• Stenting across a major bifurcation may hinder or prevent future diagnostic ortherapeutic procedures. • In patients requiring the use of antacids and/or H2-antagonists before or immediately after stent placement, oral absorption ofantiplatelet agents such as aspirin may be adversely affected. •The implantation ofthe Carotid WALLSTENT Endoprosthesis should be performed only underfluoroscopic observation with radiographic equipment providing high-resolutionimages. • Never advance the Carotid WALLSTENT Endoprosthesis without theguide wire extending from the tip. • Do not advance the Carotid WALLSTENTEndoprosthesis against significant resistance. •The Carotid WALLSTENTEndoprosthesis should be oversized in relation to the artery diameter by 1mm to2mm to prevent migration. • Do not release the Carotid WALLSTENTEndoprosthesis if unusual force is required; in such a situation use another device.• Never advance a partially deployed Carotid WALLSTENT Endoprosthesis distally.• Reconstrainment and repositioning of the Carotid WALLSTENT Endoprosthesisshould be strictly avoided when the partially deployed Carotid WALLSTENTEndoprosthesis is already in contact with the plaque of the stenosis. • Use of thisdevice in patients with hypersensitivity to cobalt, chromium, iron, nickel ormolybdenum may provoke an allergic reaction. • Avoid using power injection inthe cerebral circulation. • Implanting a stent may lead to dissection of the vesseldistal and/or proximal to the stent and may cause acute closure of the vessel,requiring additional intervention (carotid endarterectomy, further dilatation, orplacement of additional stents).The stent may cause a thrombus, distalembolization or may migrate from the site of implant down the arterial lumen.Appropriate sizing of the stent to the vessel is required to reduce the possibility ofstent migration. In the event of thrombosis of the expanded stent, thrombolysisand PTA should be attempted. • In the event of complications such as infection,pseudoaneurysm or fistulization, surgical removal of the stent may be required.• Overstretching of the artery may result in rupture and life-threatening bleeding.• Balloon angioplasty of the carotid bifurcation may initiate transienthemodynamic instability consisting of bradycardia or hypotension. Appropriatepharmacologic therapy must be immediately available.PRECAUTIONS:Through non-clinical testing, the Carotid WALLSTENT MonorailEndoprosthesis (Carotid WALLSTENT Endoprosthesis) has been shown to be MRIsafe at field strengths of 3.0Tesla or less, and a maximum whole body averagedspecific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MRI exposure.TheCarotid WALLSTENT Endoprosthesis should not migrate in this MRI environment.Non-clinical testing has not been performed to rule out the possibility of stentmigration at field strengths higher than 3.0Tesla. MRI at 3.0Tesla or less may beperformed immediately following the implantation of the Carotid WALLSTENTEndoprosthesis. MR image quality may be compromised if the area of interest isin the exact same area or relatively close to the position of the stent. MR imageartifact has been evaluated at 1.5Tesla only.ADVERSE EVENTS: Death due to any cause • Life-threatening condition (e.g.,stroke) • Persistent or significant disability/incapacity • Any event resulting in anunscheduled in-patient hospitalization or prolongation of existing hospitalization>72 hours post index procedure • Any event requiring intervention, except forcomorbid scheduled events, which are scheduled and planned during the follow-

up period • Congenital abnormality or birth defect. • Serious adverse events havebeen coded using the Medical Dictionary for Regulatory Activities (MedDRA™)version 5.0 and are presented by System Organ Class and PreferredTerm asfollows: • BLOOD AND LYMPHATIC SYSTEM DISORDERS include events such asanemia. • CARDIAC DISORDERS include events such as angina, arrhythmias,cardiac failure congestive and myocardial infarction. • EYE DISORDERS includeevents such as retinal infarction. • GASTROINTESTINAL DISORDERS includeevents such as gastrointestinal hemorrhage and retroperitoneal hemorrhage.• GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS includeevents such as death, multi-organ failure and pyrexia. • HEPATOBILIARYDISORDERS include events such as cholelithiasis. • INFECTIONS ANDINFESTATIONS include events such as pneumonia, sepsis and urinary tractinfection. • INJURY, POISONING AND PROCEDURAL COMPLICATIONS includeevents such as hip fracture and stent occlusion. • INVESTIGATIONS include eventssuch as blood creatinine increased and neurological examination abnormal.• METABOLISM AND NUTRITION DISORDERS include events such as dehydrationand hyperglycemia. • MUSCULOSKELETAL AND CONNECTIVETISSUEDISORDERS include events such as arthritis and pain. • NEOPLASMS BENIGN,MALIGNANT AND UNSPECIFIED (INCLUDING CYSTS AND POLYPS) includeevents such as carcinomas, lung cancer and neoplasms. • NERVOUS SYSTEMDISORDERS include events such as cerebral hemorrhage, cerebrovascularaccident, convulsions, dizziness, syncope and transient ischemic attack.• PSYCHIATRIC DISORDERS include events such as confusion, depression andmental status changes. • RENAL AND URINARY DISORDERS include events suchas renal failure and impairment. • REPRODUCTIVE SYSTEM AND BREASTDISORDERS include events such as vaginal hemorrhage. • RESPIRATORY,THORACIC AND MEDIASTINAL DISORDERS include events such as chronicobstructive airway disease, dyspnea, pulmonary fibrosis and respiratory failure.• SKIN AND SUBCUTANEOUSTISSUE DISORDERS include events such as skinulcer. • SURGICAL AND MEDICAL PROCEDURES include events such as aorticvalve replacement, arterial stent insertion, carotid endarterectomy, coronary arterysurgery and revascularization, and hip arthroplasty. • VASCULAR DISORDERSinclude events such as hematoma, hemorrhage, hypertension, hypotension,peripheral revascularization and vascular pseudoaneurysm.POTENTIAL ADVERSE EVENTS: Abrupt vessel closure • Additional interventionalor surgical treatment (e.g., stenting or carotid endarterectomy) • Allergic reactions(including to antiplatelet agents, contrast medium or stent materials) • Aneurysm• Angina/coronary ischemia • Arrhythmia • Arteriovenous fistula • Bacteremia orsepticemia • Bleeding • Bradycardia • Cerebral vascular event such as edema• Cerebral ischemia/transient ischemic attack • Congestive heart failure (CHF)• Death • Detachment and/or implantation of a component • Emboli (air, tissue,plaque, thrombus, device or other) • Fever • Filter thrombosis/occlusion• Hematoma • Hemorrhage • Hyperperfusion syndrome • Hypotension/hypertension • Hypotonia • Infection • Ischemia/infarction of tissue or organ• Myocardial Infarction (MI) • Pain • Pseudoaneurysm • Renal failure/insufficiency• Restenosis of stented segment • Seizure • Severe unilateral headache • Stentembolization • Stent/filter entanglement or damage • Stent migration • Stentmalposition • Stent thrombosis/occlusion • Stroke/cerebrovascular accident (CVA)• Vessel injury/dissection/perforation/rupture/trauma • Vessel occlusion orthrombosis • Vessel spasm or recoil.CAUTION: Federal law (USA) restricts this device to sale by or on the order of aphysician.

FILTERWIRE EZ™ EMBOLIC PROTECTION SYSTEMPrior to use, please see the complete “Directions for Use” for more informationon Indications, Contraindications, Warnings, Precautions, Adverse Events andOperator's Instructions.INDICATIONS FOR USE:The FilterWire EZ Embolic Protection System isindicated for use as a guide wire and embolic protection system to contain andremove embolic material (thrombus/debris) while performing angioplasty andstenting procedures in coronary saphenous vein bypass grafts and carotidarteries.The diameter of the vessel at the site of filter loop placement should bebetween 3.5mm and 5.5mm. •The safety and effectiveness of this device as anembolic protection system has not been established in the cerebral vasculature,peripheral vessels other than carotid arteries, or in treating native coronaries,including acute myocardial infarction.CONTRAINDICATIONS: Patients with severe allergy to heparin. • Patients withbleeding diathesis or other disorders which limit the use of anticoagulanttherapy.WARNINGS: Only physicians thoroughly trained in percutaneous, intravasculartechniques and procedures should use the FilterWire EZ System. •The safetyand effectiveness of coronary drug-eluting stents (DES) when used with embolicprotection devices has not been established. •The safety and effectiveness ofthe FilterWire EZ System has not been demonstrated with carotid stents otherthan the Carotid WALLSTENT® Monorail® Endoprosthesis System. • Avoid using

power injection in the cerebral circulation. Filter safety and effectiveness hasnot been tested with power injection. • Failure to follow recommended devicepreparation and delivery instructions may result in air embolism. • Introduceand advance devices slowly to prevent air embolism or trauma to thevasculature. • Do not attempt to move the protection wire without observingthe resultant tip response. • All distal wire tips have the potential to causevessel injury. Confirm that the wire tip is free within the vessel. • Do not useexcessive force when attempting to cross the lesion with the FilterWire EZSystem. • Observe all protection wire movement in the vessel underfluoroscopic imaging. • Always keep the open filter loop distal to a deployedstent. Pulling the filter loop into the stent area may lead to entanglement withthe stent and possible filter loop detachment. • Ensure that the protectionwire is stabilized throughout the procedure. Failure to stabilize the protectionwire could lead to inadvertent movement of the filter resulting in protectionwire entanglement and/or delay in the procedure. • Do not pull excessively onthe protection wire or the EZ Retrieval Sheath to avoid filter membrane tears,filter loop detachment or other protection wire damage.ADVERSE EVENTS: Possible adverse effects include, but are not limited to,the following: • Angina • Bleeding complications • Bradycardia or arrhythmias,including ventricular fibrillation or tachycardia • Congestive heart failure• Damage to or dislocation of the implanted stent(s) • Death • Detachmentand/or implantation of a component of the system • Drug reaction, allergicreaction to contrast media, medications or device materials • Emergentsurgery • Embolization of air, tissue, thrombus or other embolic debris • Endorgan ischemia, vessel thrombosis or spasm • Hypotension/hypertension• Infection (local or systemic) • Myocardial infarction • No-reflow resultingfrom reduced blood flow through the FilterWire EZ™ System filter • Puncturesite complications (i.e., vessel occlusion, hemorrhage, hematoma,pseudoaneurysm or arteriovenous fistula) • Renal insufficiency, kidney failure,hematuria • Stroke/cerebrovascular accident (CVA), transient ischemic attack(TIA) or seizure • Vessel damage, dissection, occlusion, aneurysm, perforation,rupture or injury.CAUTION: Federal law (USA) restricts this device to sale by or on the order ofa physician.

ACCULINK is a trademark of Abbott Cardiovascular Systems, Inc. Precise andPrecise Pro RX are trademarks of Cordis Corp. Protégé is a trademark of ev3Peripheral, Inc. Xact is a trademark of MedNova Ltd.

Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760-1537www.bostonscientific.comwww.carotid.com

To order product or formore information, contactcustomer service at1.888.272.1001.© 2008 Boston Scientific Corporationor its affiliates. All rights reserved.

USPV4035.108.0 OCT08

ProductandClinicalInformation

DesignedforDeliverability

RadiopaqueandReconstrainable†

TheCarotidWALLSTENT®Endoprosthesisfeaturesahighly

flexible,low-profilestentdeliverysystemdesignedtoprovideexcellenttrackingthroughtortuousanatomy.

•Uniquebraidedconstructiondesignedtopromoteexcellentstentflexibility**

•Low-profilesystemallows5For6Fguidesheathcompatibility

•Multiplelengthsanddiametersforvaryinglesionsizes

RXACCULINK®

CarotidStentCarotid

WALLSTENT®

Endoprosthesis

140

120

100

80

60

40

20

0

gm

Xact®

CarotidStentPreciseProRX

®

CarotidStent

DeliveryForce:Benchtestthatmeasurestheaverageforcerequiredtonavigatethroughabenchtopmodeloftortuosity.Smallervalue=lessforcerequired.

DeliveryForceBenchTestResults**

Radiopacity:BenchtestthatillustratesthevisibilityofastentunderC-armunderneathsimulatedtissue.

ThedesignoftheCarotidWALLSTENTEndoprosthesisisintendedtofacilitateaccuratestentplacementwithhighradiopacityandtheuniqueabilitytobereconstrained.

•Inbenchtestingagainstothercurrentlyavailablecarotidstents,CarotidWALLSTENTEndoprosthesiswasshowntobeoneofthemostradiopaquestents**

•Radiopaquemarkersontheinnershaftandretractableoutersheathofthedeliverysystemaredesignedtoaidinstentpositioning

•Uniquecatheterconstructionisengineeredtoallowthestenttobereconstrainedwhendeployedlessthan50%

TheCarotidWALLSTENTEndoprosthesisisindicatedforuseineligiblepatientswithipsilateralorbilateralcarotidarterydisease.

TheprimaryendpointoftheBEACHTrialwasone-yearmorbidityandmortality.††

21.8

71.982.9

122.6

Xact®

CarotidStentRXACCULINK

®

CarotidStent

CarotidWALLSTENT®

EndoprosthesisPrecise

®Rx

CarotidStentProtégé

®

CarotidStent

10

8

6

4

2

0 %ofPatien

tPopulatio

n

0.9%0.2%

4.5%

1.6%

5.6%

1.6%2.5%

8.9%

BEACHTrialResults‡

Non-Q-WaveMI

Q-WaveMI

StrokeDeath

Peri-Procedural

MorbidityandMortality

LateNeurological

Death

LateIpsilateral

Stroke

Morbidityand

Mortality

24-Hour30-Day31-360Days

1Year

Product Information

CatalogNumber Unconstrained

Diameter*

(mm)

UnconstrainedLength*

(mm)Vessel

Diameter(mm)

ImplantedLength(mm)

VesselDiameter

(mm)

ImplantedLength(mm)

Delivery Catheter Compatibility

OuterDiameter(F/mm)

GuidingSheath

Minimum I.D.(F/inches)

GuidingCatheter

Minimum I.D.(F/inches)

WorkingLength

(cm)

71-90071-90171-90271-90371-90471-90571-906

6888101010

22212936243137

5777999

30304050304050

4666888

36364862364959

Stenttent

Representative Length Adjustments

5.0/1.67 135 5.0/0.073 7.0/0.073

5.9/1.97 135 6.0/0.086 8.0/0.086

*Unconstrained stent diameter selected should be 1mm-2mm larger than the largest vessel to be stented.

The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. C-codesare used for hospital outpatient device reporting for Medicare and some private payers.

Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice.

Carotid WALLSTENT®

Monorail® Endoprosthesis

Closed Cell Design

The closed cell design of the Carotid WALLSTENTEndoprosthesis is intended to provide increasedscaffolding for optimal lesion coverage and asmooth inner lumen.

• The Carotid WALLSTENT Endoprosthesis demonstratedthe smallest free cell area* when compared with theleading carotid stents in bench tests**

• Closed cell design engineered to providea smooth inner lumen

Ease of use andclosed cell design

The closed cell Carotid WALLSTENT Endoprosthesis has been engineered tocombine a unique stent design with minimal free cell area* and a highly flexible,easy-to-use delivery system.

Xact®

Carotid StentCarotid

WALLSTENT®

Endoprosthesis

12

10

8

6

4

2

0

mm

2

PrecisePro RX®

Carotid StentRX ACCULINK®

Carotid Stent

Free Cell Area* BenchTest Results**

*Free Cell Area: Measures the average area (mm2)within the perimeter of connecting struts. Smaller number = smaller free cell area.**Testing performed on Carotid WALLSTENT Endoprosthesis 8mm x 21mm, Precise Pro RX 8mm x 40mm, RX ACCULINK 7-10mm x40mm, Xact 7-9mm x 40mm. Bench test results may not necessarily be indicative of clinical performance. Test results shown are formodels deemed most typically selected for placement in common carotid artery with a reference diameter of <8mm. Other modelswere also tested and yielded similar results. N=3. Data on file.

†Please note that reconstrainment and repositioning are subject to specific limitations. Please refer to Directions for Usecautions and warnings for additional information.

††See back page for additional information about the BEACHTrial.‡Patients may have had more than one event.

1.12.5

6.0

11.2

CarotidWALLSTENT®

Monorail®

Endoprosthesis

CarotidWALLSTENT®

Monorail®

Endoprosthesis

DeliverableClosedCellDesign

BEACHTRIALTrialDesign:Multi-center,prospective,single-armstudy.N=747,Roll-InGroupN=189,BilateralGroupN=78,PivotalGroupN=480(symptomatic≥50%stenosisN=112;asymptomatic≥80%stenosisN=368).47U.S.clinicalsitesparticipatedinthestudy.TrialObjective:Toevaluatetheoutcomesofpatientswithcarotidarterystenosisathighriskforcarotidendarterectomy(CEA)usingtheCarotidWALLSTENTMonorailEndoprosthesisandtheFilterWireEX

®and

FilterWireEZ™EmbolicProtectionSystems.

One-YearMorbidityandMortality:•Non-Q-wavemyocardialinfarctionwithinthe24hoursfollowingcarotidstenting

•Peri-procedural(≤30days)death,stroke,Q-wavemyocardialinfarction

•Lateipsilateralstrokeordeathduetoneurologiceventsfrom31daysuptoandincluding12-monthfollow-up

Peri-ProceduralMorbidityandMortality:•Non-Q-waveMIthrough24hourspostprocedureanddeath,strokeandQ-waveMIthrough30dayspostprocedure

CAROTIDWALLSTENT®MONORAIL®ENDOPROSTHESIS

INDICATIONS:TheCarotidWALLSTENTMonorailEndoprosthesis(CarotidWALLSTENTEndoprosthesis),usedinconjunctionwiththeBostonScientificembolicprotectionsystem,isindicatedforthetreatmentofpatientsathighriskforadverseeventsfromcarotidendarterectomyduetoeitheranatomicorcomorbidconditionswhorequirecarotidrevascularizationinthetreatmentofipsilateralorbilateralcarotidarterydiseaseandmeetthefollowingcriteria:•Patientswithneurologicalsymptomsand≥50%stenosisofthecommon,internalcarotidarteryand/orthebifurcationbyultrasoundorangiogramORpatientswithoutneurologicalsymptomsand≥80%stenosisofthecommon,internalcarotidarteryand/orthebifurcationbyultrasoundorangiogram,AND•Patientswithareferencevesseldiameterwithintherangeof4.0mmand9.0mmatthetargetlesion.CONTRAINDICATIONS:TheCarotidWALLSTENTEndoprosthesisiscontraindicatedforusein:•Patientsinwhomanticoagulantand/orantiplatelettherapyiscontraindicated•Patientswithseverevasculartortuosityoranatomythatwouldprecludethesafeintroductionofaguidecatheter,sheath,embolicprotectionsystemorstentsystem•Patientswithuncorrectedbleedingdisorders•Lesionsintheostiumofthecommoncarotidartery.GENERALWARNINGS:RefertotheDirectionsforUsesuppliedwithanyinterventionaldevicestobeusedinconjunctionwiththeCarotidWALLSTENTEndoprosthesisfortheirintendeduses,contraindicationsandpotentialcomplications.•ThesafetyandefficacyoftheCarotidWALLSTENTEndoprosthesishavenotbeendemonstratedwithembolicprotectiondevicesotherthantheFilterWireEZ™System.•RiskofdistalembolizationmaybehigheriftheCarotidWALLSTENTEndoprosthesiscannotbeusedinconjunctionwithanembolicprotectionsystemduringthecarotidstentingprocedure.•Thelong-termperformanceoftheCarotidWALLSTENTEndoprosthesishasnotbeenestablished.•Stentingacrossamajorbifurcationmayhinderorpreventfuturediagnosticortherapeuticprocedures.•Inpatientsrequiringtheuseofantacidsand/orH2-antagonistsbeforeorimmediatelyafterstentplacement,oralabsorptionofantiplateletagentssuchasaspirinmaybeadverselyaffected.•TheimplantationoftheCarotidWALLSTENTEndoprosthesisshouldbeperformedonlyunderfluoroscopicobservationwithradiographicequipmentprovidinghigh-resolutionimages.•NeveradvancetheCarotidWALLSTENTEndoprosthesiswithouttheguidewireextendingfromthetip.•DonotadvancetheCarotidWALLSTENTEndoprosthesisagainstsignificantresistance.•TheCarotidWALLSTENTEndoprosthesisshouldbeoversizedinrelationtothearterydiameterby1mmto2mmtopreventmigration.•DonotreleasetheCarotidWALLSTENTEndoprosthesisifunusualforceisrequired;insuchasituationuseanotherdevice.•NeveradvanceapartiallydeployedCarotidWALLSTENTEndoprosthesisdistally.•ReconstrainmentandrepositioningoftheCarotidWALLSTENTEndoprosthesisshouldbestrictlyavoidedwhenthepartiallydeployedCarotidWALLSTENTEndoprosthesisisalreadyincontactwiththeplaqueofthestenosis.•Useofthisdeviceinpatientswithhypersensitivitytocobalt,chromium,iron,nickelormolybdenummayprovokeanallergicreaction.•Avoidusingpowerinjectioninthecerebralcirculation.•Implantingastentmayleadtodissectionofthevesseldistaland/orproximaltothestentandmaycauseacuteclosureofthevessel,requiringadditionalintervention(carotidendarterectomy,furtherdilatation,orplacementofadditionalstents).Thestentmaycauseathrombus,distalembolizationormaymigratefromthesiteofimplantdownthearteriallumen.Appropriatesizingofthestenttothevesselisrequiredtoreducethepossibilityofstentmigration.Intheeventofthrombosisoftheexpandedstent,thrombolysisandPTAshouldbeattempted.•Intheeventofcomplicationssuchasinfection,pseudoaneurysmorfistulization,surgicalremovalofthestentmayberequired.•Overstretchingofthearterymayresultinruptureandlife-threateningbleeding.•Balloonangioplastyofthecarotidbifurcationmayinitiatetransienthemodynamicinstabilityconsistingofbradycardiaorhypotension.Appropriatepharmacologictherapymustbeimmediatelyavailable.PRECAUTIONS:Throughnon-clinicaltesting,theCarotidWALLSTENTMonorailEndoprosthesis(CarotidWALLSTENTEndoprosthesis)hasbeenshowntobeMRIsafeatfieldstrengthsof3.0Teslaorless,andamaximumwholebodyaveragedspecificabsorptionrate(SAR)of2.0W/kgfor15minutesofMRIexposure.TheCarotidWALLSTENTEndoprosthesisshouldnotmigrateinthisMRIenvironment.Non-clinicaltestinghasnotbeenperformedtoruleoutthepossibilityofstentmigrationatfieldstrengthshigherthan3.0Tesla.MRIat3.0TeslaorlessmaybeperformedimmediatelyfollowingtheimplantationoftheCarotidWALLSTENTEndoprosthesis.MRimagequalitymaybecompromisediftheareaofinterestisintheexactsameareaorrelativelyclosetothepositionofthestent.MRimageartifacthasbeenevaluatedat1.5Teslaonly.ADVERSEEVENTS:Deathduetoanycause•Life-threateningcondition(e.g.,stroke)•Persistentorsignificantdisability/incapacity•Anyeventresultinginanunscheduledin-patienthospitalizationorprolongationofexistinghospitalization>72hourspostindexprocedure•Anyeventrequiringintervention,exceptforcomorbidscheduledevents,whicharescheduledandplannedduringthefollow-

upperiod•Congenitalabnormalityorbirthdefect.•SeriousadverseeventshavebeencodedusingtheMedicalDictionaryforRegulatoryActivities(MedDRA™)version5.0andarepresentedbySystemOrganClassandPreferredTermasfollows:•BLOODANDLYMPHATICSYSTEMDISORDERSincludeeventssuchasanemia.•CARDIACDISORDERSincludeeventssuchasangina,arrhythmias,cardiacfailurecongestiveandmyocardialinfarction.•EYEDISORDERSincludeeventssuchasretinalinfarction.•GASTROINTESTINALDISORDERSincludeeventssuchasgastrointestinalhemorrhageandretroperitonealhemorrhage.•GENERALDISORDERSANDADMINISTRATIONSITECONDITIONSincludeeventssuchasdeath,multi-organfailureandpyrexia.•HEPATOBILIARYDISORDERSincludeeventssuchascholelithiasis.•INFECTIONSANDINFESTATIONSincludeeventssuchaspneumonia,sepsisandurinarytractinfection.•INJURY,POISONINGANDPROCEDURALCOMPLICATIONSincludeeventssuchashipfractureandstentocclusion.•INVESTIGATIONSincludeeventssuchasbloodcreatinineincreasedandneurologicalexaminationabnormal.•METABOLISMANDNUTRITIONDISORDERSincludeeventssuchasdehydrationandhyperglycemia.•MUSCULOSKELETALANDCONNECTIVETISSUEDISORDERSincludeeventssuchasarthritisandpain.•NEOPLASMSBENIGN,MALIGNANTANDUNSPECIFIED(INCLUDINGCYSTSANDPOLYPS)includeeventssuchascarcinomas,lungcancerandneoplasms.•NERVOUSSYSTEMDISORDERSincludeeventssuchascerebralhemorrhage,cerebrovascularaccident,convulsions,dizziness,syncopeandtransientischemicattack.•PSYCHIATRICDISORDERSincludeeventssuchasconfusion,depressionandmentalstatuschanges.•RENALANDURINARYDISORDERSincludeeventssuchasrenalfailureandimpairment.•REPRODUCTIVESYSTEMANDBREASTDISORDERSincludeeventssuchasvaginalhemorrhage.•RESPIRATORY,THORACICANDMEDIASTINALDISORDERSincludeeventssuchaschronicobstructiveairwaydisease,dyspnea,pulmonaryfibrosisandrespiratoryfailure.•SKINANDSUBCUTANEOUSTISSUEDISORDERSincludeeventssuchasskinulcer.•SURGICALANDMEDICALPROCEDURESincludeeventssuchasaorticvalvereplacement,arterialstentinsertion,carotidendarterectomy,coronaryarterysurgeryandrevascularization,andhiparthroplasty.•VASCULARDISORDERSincludeeventssuchashematoma,hemorrhage,hypertension,hypotension,peripheralrevascularizationandvascularpseudoaneurysm.POTENTIALADVERSEEVENTS:Abruptvesselclosure•Additionalinterventionalorsurgicaltreatment(e.g.,stentingorcarotidendarterectomy)•Allergicreactions(includingtoantiplateletagents,contrastmediumorstentmaterials)•Aneurysm•Angina/coronaryischemia•Arrhythmia•Arteriovenousfistula•Bacteremiaorsepticemia•Bleeding•Bradycardia•Cerebralvasculareventsuchasedema•Cerebralischemia/transientischemicattack•Congestiveheartfailure(CHF)•Death•Detachmentand/orimplantationofacomponent•Emboli(air,tissue,plaque,thrombus,deviceorother)•Fever•Filterthrombosis/occlusion•Hematoma•Hemorrhage•Hyperperfusionsyndrome•Hypotension/hypertension•Hypotonia•Infection•Ischemia/infarctionoftissueororgan•MyocardialInfarction(MI)•Pain•Pseudoaneurysm•Renalfailure/insufficiency•Restenosisofstentedsegment•Seizure•Severeunilateralheadache•Stentembolization•Stent/filterentanglementordamage•Stentmigration•Stentmalposition•Stentthrombosis/occlusion•Stroke/cerebrovascularaccident(CVA)•Vesselinjury/dissection/perforation/rupture/trauma•Vesselocclusionorthrombosis•Vesselspasmorrecoil.CAUTION:Federallaw(USA)restrictsthisdevicetosalebyorontheorderofaphysician.

FILTERWIREEZ™EMBOLICPROTECTIONSYSTEM

Priortouse,pleaseseethecomplete“DirectionsforUse”formoreinformationonIndications,Contraindications,Warnings,Precautions,AdverseEventsandOperator'sInstructions.INDICATIONSFORUSE:TheFilterWireEZEmbolicProtectionSystemisindicatedforuseasaguidewireandembolicprotectionsystemtocontainandremoveembolicmaterial(thrombus/debris)whileperformingangioplastyandstentingproceduresincoronarysaphenousveinbypassgraftsandcarotidarteries.Thediameterofthevesselatthesiteoffilterloopplacementshouldbebetween3.5mmand5.5mm.•Thesafetyandeffectivenessofthisdeviceasanembolicprotectionsystemhasnotbeenestablishedinthecerebralvasculature,peripheralvesselsotherthancarotidarteries,orintreatingnativecoronaries,includingacutemyocardialinfarction.CONTRAINDICATIONS:Patientswithsevereallergytoheparin.•Patientswithbleedingdiathesisorotherdisorderswhichlimittheuseofanticoagulanttherapy.WARNINGS:Onlyphysiciansthoroughlytrainedinpercutaneous,intravasculartechniquesandproceduresshouldusetheFilterWireEZSystem.•Thesafetyandeffectivenessofcoronarydrug-elutingstents(DES)whenusedwithembolicprotectiondeviceshasnotbeenestablished.•ThesafetyandeffectivenessoftheFilterWireEZSystemhasnotbeendemonstratedwithcarotidstentsotherthantheCarotidWALLSTENT

®Monorail

®EndoprosthesisSystem.•Avoidusing

powerinjectioninthecerebralcirculation.Filtersafetyandeffectivenesshasnotbeentestedwithpowerinjection.•Failuretofollowrecommendeddevicepreparationanddeliveryinstructionsmayresultinairembolism.•Introduceandadvancedevicesslowlytopreventairembolismortraumatothevasculature.•Donotattempttomovetheprotectionwirewithoutobservingtheresultanttipresponse.•Alldistalwiretipshavethepotentialtocausevesselinjury.Confirmthatthewiretipisfreewithinthevessel.•DonotuseexcessiveforcewhenattemptingtocrossthelesionwiththeFilterWireEZSystem.•Observeallprotectionwiremovementinthevesselunderfluoroscopicimaging.•Alwayskeeptheopenfilterloopdistaltoadeployedstent.Pullingthefilterloopintothestentareamayleadtoentanglementwiththestentandpossiblefilterloopdetachment.•Ensurethattheprotectionwireisstabilizedthroughouttheprocedure.Failuretostabilizetheprotectionwirecouldleadtoinadvertentmovementofthefilterresultinginprotectionwireentanglementand/ordelayintheprocedure.•DonotpullexcessivelyontheprotectionwireortheEZRetrievalSheathtoavoidfiltermembranetears,filterloopdetachmentorotherprotectionwiredamage.ADVERSEEVENTS:Possibleadverseeffectsinclude,butarenotlimitedto,thefollowing:•Angina•Bleedingcomplications•Bradycardiaorarrhythmias,includingventricularfibrillationortachycardia•Congestiveheartfailure•Damagetoordislocationoftheimplantedstent(s)•Death•Detachmentand/orimplantationofacomponentofthesystem•Drugreaction,allergicreactiontocontrastmedia,medicationsordevicematerials•Emergentsurgery•Embolizationofair,tissue,thrombusorotherembolicdebris•Endorganischemia,vesselthrombosisorspasm•Hypotension/hypertension•Infection(localorsystemic)•Myocardialinfarction•No-reflowresultingfromreducedbloodflowthroughtheFilterWireEZ

™Systemfilter•Puncture

sitecomplications(i.e.,vesselocclusion,hemorrhage,hematoma,pseudoaneurysmorarteriovenousfistula)•Renalinsufficiency,kidneyfailure,hematuria•Stroke/cerebrovascularaccident(CVA),transientischemicattack(TIA)orseizure•Vesseldamage,dissection,occlusion,aneurysm,perforation,ruptureorinjury.CAUTION:Federallaw(USA)restrictsthisdevicetosalebyorontheorderofaphysician.

ACCULINKisatrademarkofAbbottCardiovascularSystems,Inc.PreciseandPreciseProRXaretrademarksofCordisCorp.Protégéisatrademarkofev3Peripheral,Inc.XactisatrademarkofMedNovaLtd.

BostonScientificCorporationOneBostonScientificPlaceNatick,MA01760-1537www.bostonscientific.comwww.carotid.com

Toorderproductorformoreinformation,contactcustomerserviceat1.888.272.1001.©2008BostonScientificCorporationoritsaffiliates.Allrightsreserved.

USPV4035.108.0OCT08

Product and Clinical Information

Designed for Deliverability

Radiopaque and Reconstrainable†

The Carotid WALLSTENT® Endoprosthesis features a highlyflexible, low-profile stent delivery system designed to provideexcellent tracking through tortuous anatomy.

• Unique braided construction designed to promote excellentstent flexibility**

• Low-profile system allows 5F or 6F guide sheath compatibility

• Multiple lengths and diameters for varying lesion sizes

RX ACCULINK®

Carotid StentCarotid

WALLSTENT®

Endoprosthesis

140

120

100

80

60

40

20

0

gm

Xact®

Carotid StentPrecisePro RX®

Carotid Stent

Delivery Force: Bench test that measures the averageforce required to navigate through a bench top model oftortuosity. Smaller value = less force required.

Delivery Force BenchTest Results**

Radiopacity: Bench test that illustrates thevisibility of a stent under C-arm underneathsimulated tissue.

The design of the Carotid WALLSTENT Endoprosthesis is intended to facilitateaccurate stent placement with high radiopacity and the unique ability tobe reconstrained.

• In bench testing against other currently available carotid stents, Carotid WALLSTENTEndoprosthesis was shown to be one of the most radiopaque stents**

• Radiopaque markers on the inner shaft and retractable outer sheath of thedelivery system are designed to aid in stent positioning

• Unique catheter construction is engineered to allow the stent to be reconstrainedwhen deployed less than 50%

The Carotid WALLSTENT Endoprosthesis is indicated foruse in eligible patients with ipsilateral or bilateral carotidartery disease.

The primary endpoint of the BEACHTrial was one-yearmorbidity and mortality.††

21.8

71.982.9

122.6

Xact®

Carotid StentRX ACCULINK®

Carotid Stent

Carotid WALLSTENT®

EndoprosthesisPrecise® RxCarotid Stent

Protégé®

Carotid Stent

10

8

6

4

2

0%ofPatientPopulation

0.9%0.2%

4.5%

1.6%

5.6%

1.6%2.5%

8.9%

BEACH Trial Results‡

Non-Q

-Wav

e MI

Q-Wa

veMI

Stro

keDe

ath

Peri-

Proc

edur

al

Morb

idity

and M

ortal

ity

Late

Neur

ologic

al

Death

Late

Ipsila

teral

Stro

ke

Morb

idity

and

Morta

lity

24-Hour30-Day31-360 Days

1Year

ProductInformation

CatalogNumberUnconstrained

Diameter*

(mm)

UnconstrainedLength

*

(mm)Vessel

Diameter(mm)

ImplantedLength(mm)

VesselDiameter

(mm)

ImplantedLength(mm)

DeliveryCatheterCompatibility

OuterDiameter(F/mm)

GuidingSheath

MinimumI.D.(F/inches)

GuidingCatheter

MinimumI.D.(F/inches)

WorkingLength

(cm)

71-90071-90171-90271-90371-90471-90571-906

6888101010

22212936243137

5777999

30304050304050

4666888

36364862364959

Stenttent

RepresentativeLengthAdjustments

5.0/1.671355.0/0.0737.0/0.073

5.9/1.971356.0/0.0868.0/0.086

*Unconstrainedstentdiameterselectedshouldbe1mm-2mmlargerthanthelargestvesseltobestented.

TheC-codeusedforthisproductisC1876,Stent,non-coated/non-coveredwithdeliverysystem.C-codesareusedforhospitaloutpatientdevicereportingforMedicareandsomeprivatepayers.

Note:BostonScientificisnotresponsibleforthecorrectuseofcodesonsubmittedclaims;thisinformationdoesnotconstitutereimbursementorlegaladvice.

Carotid WALLSTENT®

Monorail® Endoprosthesis Carotid WALLSTENT®

Monorail® Endoprosthesis

Deliverable ClosedCell Design

BEACHTRIALTrial Design: Multi-center, prospective, single-arm study.N=747, Roll-In Group N=189, Bilateral Group N=78, PivotalGroup N=480 (symptomatic ≥50% stenosis N=112;asymptomatic ≥80% stenosis N=368). 47 U.S. clinical sitesparticipated in the study.Trial Objective:To evaluate the outcomes of patients withcarotid artery stenosis at high risk for carotidendarterectomy (CEA) using the Carotid WALLSTENTMonorail Endoprosthesis and the FilterWire EX® andFilterWire EZ™ Embolic Protection Systems.

One-Year Morbidity and Mortality:•Non-Q-wave myocardial infarction within the 24 hoursfollowing carotid stenting

•Peri-procedural (≤30 days) death, stroke, Q-wavemyocardial infarction

•Late ipsilateral stroke or death due to neurologic eventsfrom 31 days up to and including 12-month follow-up

Peri-Procedural Morbidity and Mortality:•Non-Q-wave MI through 24 hours post procedure anddeath, stroke and Q-wave MI through 30 days postprocedure

CAROTIDWALLSTENT® MONORAIL® ENDOPROSTHESISINDICATIONS:The Carotid WALLSTENT Monorail Endoprosthesis (CarotidWALLSTENT Endoprosthesis), used in conjunction with the Boston Scientificembolic protection system, is indicated for the treatment of patients at high riskfor adverse events from carotid endarterectomy due to either anatomic orcomorbid conditions who require carotid revascularization in the treatment ofipsilateral or bilateral carotid artery disease and meet the following criteria:• Patients with neurological symptoms and ≥50% stenosis of the common, internalcarotid artery and/or the bifurcation by ultrasound or angiogram OR patientswithout neurological symptoms and ≥80% stenosis of the common, internalcarotid artery and/or the bifurcation by ultrasound or angiogram, AND • Patientswith a reference vessel diameter within the range of 4.0mm and 9.0mm at thetarget lesion.CONTRAINDICATIONS:The Carotid WALLSTENT Endoprosthesis iscontraindicated for use in: • Patients in whom anticoagulant and/or antiplatelettherapy is contraindicated • Patients with severe vascular tortuosity or anatomythat would preclude the safe introduction of a guide catheter, sheath, embolicprotection system or stent system • Patients with uncorrected bleeding disorders• Lesions in the ostium of the common carotid artery.GENERALWARNINGS: Refer to the Directions for Use supplied with anyinterventional devices to be used in conjunction with the Carotid WALLSTENTEndoprosthesis for their intended uses, contraindications and potentialcomplications. •The safety and efficacy of the Carotid WALLSTENT Endoprosthesishave not been demonstrated with embolic protection devices other than theFilterWire EZ™ System. • Risk of distal embolization may be higher if the CarotidWALLSTENT Endoprosthesis cannot be used in conjunction with an embolicprotection system during the carotid stenting procedure. •The long-termperformance of the Carotid WALLSTENT Endoprosthesis has not been established.• Stenting across a major bifurcation may hinder or prevent future diagnostic ortherapeutic procedures. • In patients requiring the use of antacids and/or H2-antagonists before or immediately after stent placement, oral absorption ofantiplatelet agents such as aspirin may be adversely affected. •The implantation ofthe Carotid WALLSTENT Endoprosthesis should be performed only underfluoroscopic observation with radiographic equipment providing high-resolutionimages. • Never advance the Carotid WALLSTENT Endoprosthesis without theguide wire extending from the tip. • Do not advance the Carotid WALLSTENTEndoprosthesis against significant resistance. •The Carotid WALLSTENTEndoprosthesis should be oversized in relation to the artery diameter by 1mm to2mm to prevent migration. • Do not release the Carotid WALLSTENTEndoprosthesis if unusual force is required; in such a situation use another device.• Never advance a partially deployed Carotid WALLSTENT Endoprosthesis distally.• Reconstrainment and repositioning of the Carotid WALLSTENT Endoprosthesisshould be strictly avoided when the partially deployed Carotid WALLSTENTEndoprosthesis is already in contact with the plaque of the stenosis. • Use of thisdevice in patients with hypersensitivity to cobalt, chromium, iron, nickel ormolybdenum may provoke an allergic reaction. • Avoid using power injection inthe cerebral circulation. • Implanting a stent may lead to dissection of the vesseldistal and/or proximal to the stent and may cause acute closure of the vessel,requiring additional intervention (carotid endarterectomy, further dilatation, orplacement of additional stents).The stent may cause a thrombus, distalembolization or may migrate from the site of implant down the arterial lumen.Appropriate sizing of the stent to the vessel is required to reduce the possibility ofstent migration. In the event of thrombosis of the expanded stent, thrombolysisand PTA should be attempted. • In the event of complications such as infection,pseudoaneurysm or fistulization, surgical removal of the stent may be required.• Overstretching of the artery may result in rupture and life-threatening bleeding.• Balloon angioplasty of the carotid bifurcation may initiate transienthemodynamic instability consisting of bradycardia or hypotension. Appropriatepharmacologic therapy must be immediately available.PRECAUTIONS:Through non-clinical testing, the Carotid WALLSTENT MonorailEndoprosthesis (Carotid WALLSTENT Endoprosthesis) has been shown to be MRIsafe at field strengths of 3.0Tesla or less, and a maximum whole body averagedspecific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MRI exposure.TheCarotid WALLSTENT Endoprosthesis should not migrate in this MRI environment.Non-clinical testing has not been performed to rule out the possibility of stentmigration at field strengths higher than 3.0Tesla. MRI at 3.0Tesla or less may beperformed immediately following the implantation of the Carotid WALLSTENTEndoprosthesis. MR image quality may be compromised if the area of interest isin the exact same area or relatively close to the position of the stent. MR imageartifact has been evaluated at 1.5Tesla only.ADVERSE EVENTS: Death due to any cause • Life-threatening condition (e.g.,stroke) • Persistent or significant disability/incapacity • Any event resulting in anunscheduled in-patient hospitalization or prolongation of existing hospitalization>72 hours post index procedure • Any event requiring intervention, except forcomorbid scheduled events, which are scheduled and planned during the follow-

up period • Congenital abnormality or birth defect. • Serious adverse events havebeen coded using the Medical Dictionary for Regulatory Activities (MedDRA™)version 5.0 and are presented by System Organ Class and PreferredTerm asfollows: • BLOOD AND LYMPHATIC SYSTEM DISORDERS include events such asanemia. • CARDIAC DISORDERS include events such as angina, arrhythmias,cardiac failure congestive and myocardial infarction. • EYE DISORDERS includeevents such as retinal infarction. • GASTROINTESTINAL DISORDERS includeevents such as gastrointestinal hemorrhage and retroperitoneal hemorrhage.• GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS includeevents such as death, multi-organ failure and pyrexia. • HEPATOBILIARYDISORDERS include events such as cholelithiasis. • INFECTIONS ANDINFESTATIONS include events such as pneumonia, sepsis and urinary tractinfection. • INJURY, POISONING AND PROCEDURAL COMPLICATIONS includeevents such as hip fracture and stent occlusion. • INVESTIGATIONS include eventssuch as blood creatinine increased and neurological examination abnormal.• METABOLISM AND NUTRITION DISORDERS include events such as dehydrationand hyperglycemia. • MUSCULOSKELETAL AND CONNECTIVETISSUEDISORDERS include events such as arthritis and pain. • NEOPLASMS BENIGN,MALIGNANT AND UNSPECIFIED (INCLUDING CYSTS AND POLYPS) includeevents such as carcinomas, lung cancer and neoplasms. • NERVOUS SYSTEMDISORDERS include events such as cerebral hemorrhage, cerebrovascularaccident, convulsions, dizziness, syncope and transient ischemic attack.• PSYCHIATRIC DISORDERS include events such as confusion, depression andmental status changes. • RENAL AND URINARY DISORDERS include events suchas renal failure and impairment. • REPRODUCTIVE SYSTEM AND BREASTDISORDERS include events such as vaginal hemorrhage. • RESPIRATORY,THORACIC AND MEDIASTINAL DISORDERS include events such as chronicobstructive airway disease, dyspnea, pulmonary fibrosis and respiratory failure.• SKIN AND SUBCUTANEOUSTISSUE DISORDERS include events such as skinulcer. • SURGICAL AND MEDICAL PROCEDURES include events such as aorticvalve replacement, arterial stent insertion, carotid endarterectomy, coronary arterysurgery and revascularization, and hip arthroplasty. • VASCULAR DISORDERSinclude events such as hematoma, hemorrhage, hypertension, hypotension,peripheral revascularization and vascular pseudoaneurysm.POTENTIAL ADVERSE EVENTS: Abrupt vessel closure • Additional interventionalor surgical treatment (e.g., stenting or carotid endarterectomy) • Allergic reactions(including to antiplatelet agents, contrast medium or stent materials) • Aneurysm• Angina/coronary ischemia • Arrhythmia • Arteriovenous fistula • Bacteremia orsepticemia • Bleeding • Bradycardia • Cerebral vascular event such as edema• Cerebral ischemia/transient ischemic attack • Congestive heart failure (CHF)• Death • Detachment and/or implantation of a component • Emboli (air, tissue,plaque, thrombus, device or other) • Fever • Filter thrombosis/occlusion• Hematoma • Hemorrhage • Hyperperfusion syndrome • Hypotension/hypertension • Hypotonia • Infection • Ischemia/infarction of tissue or organ• Myocardial Infarction (MI) • Pain • Pseudoaneurysm • Renal failure/insufficiency• Restenosis of stented segment • Seizure • Severe unilateral headache • Stentembolization • Stent/filter entanglement or damage • Stent migration • Stentmalposition • Stent thrombosis/occlusion • Stroke/cerebrovascular accident (CVA)• Vessel injury/dissection/perforation/rupture/trauma • Vessel occlusion orthrombosis • Vessel spasm or recoil.CAUTION: Federal law (USA) restricts this device to sale by or on the order of aphysician.

FILTERWIRE EZ™ EMBOLIC PROTECTION SYSTEMPrior to use, please see the complete “Directions for Use” for more informationon Indications, Contraindications, Warnings, Precautions, Adverse Events andOperator's Instructions.INDICATIONS FOR USE:The FilterWire EZ Embolic Protection System isindicated for use as a guide wire and embolic protection system to contain andremove embolic material (thrombus/debris) while performing angioplasty andstenting procedures in coronary saphenous vein bypass grafts and carotidarteries.The diameter of the vessel at the site of filter loop placement should bebetween 3.5mm and 5.5mm. •The safety and effectiveness of this device as anembolic protection system has not been established in the cerebral vasculature,peripheral vessels other than carotid arteries, or in treating native coronaries,including acute myocardial infarction.CONTRAINDICATIONS: Patients with severe allergy to heparin. • Patients withbleeding diathesis or other disorders which limit the use of anticoagulanttherapy.WARNINGS: Only physicians thoroughly trained in percutaneous, intravasculartechniques and procedures should use the FilterWire EZ System. •The safetyand effectiveness of coronary drug-eluting stents (DES) when used with embolicprotection devices has not been established. •The safety and effectiveness ofthe FilterWire EZ System has not been demonstrated with carotid stents otherthan the Carotid WALLSTENT® Monorail® Endoprosthesis System. • Avoid using

power injection in the cerebral circulation. Filter safety and effectiveness hasnot been tested with power injection. • Failure to follow recommended devicepreparation and delivery instructions may result in air embolism. • Introduceand advance devices slowly to prevent air embolism or trauma to thevasculature. • Do not attempt to move the protection wire without observingthe resultant tip response. • All distal wire tips have the potential to causevessel injury. Confirm that the wire tip is free within the vessel. • Do not useexcessive force when attempting to cross the lesion with the FilterWire EZSystem. • Observe all protection wire movement in the vessel underfluoroscopic imaging. • Always keep the open filter loop distal to a deployedstent. Pulling the filter loop into the stent area may lead to entanglement withthe stent and possible filter loop detachment. • Ensure that the protectionwire is stabilized throughout the procedure. Failure to stabilize the protectionwire could lead to inadvertent movement of the filter resulting in protectionwire entanglement and/or delay in the procedure. • Do not pull excessively onthe protection wire or the EZ Retrieval Sheath to avoid filter membrane tears,filter loop detachment or other protection wire damage.ADVERSE EVENTS: Possible adverse effects include, but are not limited to,the following: • Angina • Bleeding complications • Bradycardia or arrhythmias,including ventricular fibrillation or tachycardia • Congestive heart failure• Damage to or dislocation of the implanted stent(s) • Death • Detachmentand/or implantation of a component of the system • Drug reaction, allergicreaction to contrast media, medications or device materials • Emergentsurgery • Embolization of air, tissue, thrombus or other embolic debris • Endorgan ischemia, vessel thrombosis or spasm • Hypotension/hypertension• Infection (local or systemic) • Myocardial infarction • No-reflow resultingfrom reduced blood flow through the FilterWire EZ™ System filter • Puncturesite complications (i.e., vessel occlusion, hemorrhage, hematoma,pseudoaneurysm or arteriovenous fistula) • Renal insufficiency, kidney failure,hematuria • Stroke/cerebrovascular accident (CVA), transient ischemic attack(TIA) or seizure • Vessel damage, dissection, occlusion, aneurysm, perforation,rupture or injury.CAUTION: Federal law (USA) restricts this device to sale by or on the order ofa physician.

ACCULINK is a trademark of Abbott Cardiovascular Systems, Inc. Precise andPrecise Pro RX are trademarks of Cordis Corp. Protégé is a trademark of ev3Peripheral, Inc. Xact is a trademark of MedNova Ltd.

Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760-1537www.bostonscientific.comwww.carotid.com

To order product or formore information, contactcustomer service at1.888.272.1001.© 2008 Boston Scientific Corporationor its affiliates. All rights reserved.

USPV4035.108.0 OCT08

ProductandClinicalInformation

DesignedforDeliverability

RadiopaqueandReconstrainable†

TheCarotidWALLSTENT®Endoprosthesisfeaturesahighly

flexible,low-profilestentdeliverysystemdesignedtoprovideexcellenttrackingthroughtortuousanatomy.

•Uniquebraidedconstructiondesignedtopromoteexcellentstentflexibility**

•Low-profilesystemallows5For6Fguidesheathcompatibility

•Multiplelengthsanddiametersforvaryinglesionsizes

RXACCULINK®

CarotidStentCarotid

WALLSTENT®

Endoprosthesis

140

120

100

80

60

40

20

0

gm

Xact®

CarotidStentPreciseProRX

®

CarotidStent

DeliveryForce:Benchtestthatmeasurestheaverageforcerequiredtonavigatethroughabenchtopmodeloftortuosity.Smallervalue=lessforcerequired.

DeliveryForceBenchTestResults**

Radiopacity:BenchtestthatillustratesthevisibilityofastentunderC-armunderneathsimulatedtissue.

ThedesignoftheCarotidWALLSTENTEndoprosthesisisintendedtofacilitateaccuratestentplacementwithhighradiopacityandtheuniqueabilitytobereconstrained.

•Inbenchtestingagainstothercurrentlyavailablecarotidstents,CarotidWALLSTENTEndoprosthesiswasshowntobeoneofthemostradiopaquestents**

•Radiopaquemarkersontheinnershaftandretractableoutersheathofthedeliverysystemaredesignedtoaidinstentpositioning

•Uniquecatheterconstructionisengineeredtoallowthestenttobereconstrainedwhendeployedlessthan50%

TheCarotidWALLSTENTEndoprosthesisisindicatedforuseineligiblepatientswithipsilateralorbilateralcarotidarterydisease.

TheprimaryendpointoftheBEACHTrialwasone-yearmorbidityandmortality.††

21.8

71.982.9

122.6

Xact®

CarotidStentRXACCULINK

®

CarotidStent

CarotidWALLSTENT®

EndoprosthesisPrecise

®Rx

CarotidStentProtégé

®

CarotidStent

10

8

6

4

2

0 %ofPatien

tPopulatio

n

0.9%0.2%

4.5%

1.6%

5.6%

1.6%2.5%

8.9%

BEACHTrialResults‡

Non-Q-WaveMI

Q-WaveMI

StrokeDeath

Peri-Procedural

MorbidityandMortality

LateNeurological

Death

LateIpsilateral

Stroke

Morbidityand

Mortality

24-Hour30-Day31-360Days

1Year

Product Information

CatalogNumber Unconstrained

Diameter*

(mm)

UnconstrainedLength*

(mm)Vessel

Diameter(mm)

ImplantedLength(mm)

VesselDiameter

(mm)

ImplantedLength(mm)

Delivery Catheter Compatibility

OuterDiameter(F/mm)

GuidingSheath

Minimum I.D.(F/inches)

GuidingCatheter

Minimum I.D.(F/inches)

WorkingLength

(cm)

71-90071-90171-90271-90371-90471-90571-906

6888101010

22212936243137

5777999

30304050304050

4666888

36364862364959

Stenttent

Representative Length Adjustments

5.0/1.67 135 5.0/0.073 7.0/0.073

5.9/1.97 135 6.0/0.086 8.0/0.086

*Unconstrained stent diameter selected should be 1mm-2mm larger than the largest vessel to be stented.

The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. C-codesare used for hospital outpatient device reporting for Medicare and some private payers.

Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice.