Keith Dawkins MD FRCP FACC FSCAIKeith Dawkins MD FRCP FACC FSCAIChief Medical OfficerChief Medical OfficerSenior Vice PresidentSenior Vice PresidentBoston Scientific CorporationBoston Scientific Corporation

Boston ScientificBoston ScientificProgramme UpdateProgramme Update

London – January 26, 2011London – January 26, 2011

Conflicts of InterestConflicts of Interest

EmployeeBoston Scientific Corporation

StockholderBoston Scientific Corporation

Element Stent Platform

Next Generation DES

BSC Structural Heart ProgrammeSadra Lotus™ Valve

Atritech Watchman Device

Element Stent PlatformElement Stent Platform

Geometry designed for drug delivery

Four stent modelsConsistent surface-to-artery ratios

Apex™ balloonBi-component balloonMultilayer

Platinum Chromium AlloyThin strutsRadio-opaqueLow recoilHigh radial strength

Platinum Chromium Platinum Chromium (Element Stent)(Element Stent)

ChromiumChromium18%18%

PlatinumPlatinum**

33%33%

IronIron37%37%

NickelNickel9%9%

ManganeseManganese0.05%0.05%

MolybdenumMolybdenum2.6%2.6%

**Platinum fully incorporated in the alloy (not coating)Platinum fully incorporated in the alloy (not coating)

Comparative Radial StrengthComparative Radial StrengthR

adia

l Fo

re (

New

tons/

mm

)R

adia

l Fo

re (

New

tons/

mm

)

Xience VXience V EndeavorEndeavorXience PrimeXience Prime CypherCypher Taxus LibertéTaxus Liberté Taxus ElementTaxus Element

Cobalt ChromeCobalt Chrome Stainless SteelStainless SteelPlatinumPlatinumChromeChrome

Platinum Chrome has 36% less Recoil than Cobalt Chrome

Comparative Stent RecoilComparative Stent RecoilPerc

en

t (%

) R

eco

ilPerc

en

t (%

) R

eco

il

Xience VXience V EndeavorEndeavor Xience PrimeXience Prime CypherCypher Taxus LibertéTaxus Liberté Taxus ElementTaxus Element

Cobalt ChromeCobalt Chrome Stainless SteelStainless SteelPlatinumPlatinumChromeChrome

Platinum Chrome has 70% more Radial Strength than Cobalt Chrome

Taxus LibertéTaxus Liberté

Ste

nt S

trut T

hickn

ess (µ

m)

Ste

nt S

trut T

hickn

ess (µ

m)

Taxus ExpressTaxus Express Taxus ElementTaxus Element

Avera

ge B

end C

ycl

es

Avera

ge B

end C

ycl

es

befo

re F

ract

ure

(m

illio

n)

befo

re F

ract

ure

(m

illio

n)

Fracture Resistance (Bend Fracture Resistance (Bend Fatigue)Fatigue)

Taxus Element has Thinner Struts Taxus Element has Thinner Struts andand Higher Fracture Resistance Higher Fracture Resistance

306x306x

Comparative Drug LoadComparative Drug LoadD

rug W

eig

ht

(μg)*

PromusPromusElementElement

CypherCypher EndeavorEndeavorResoluteResolute

BioMatrixBioMatrixBioFreedomBioFreedom

*Drug Load 3.0 x 18mm stent*Drug Load 3.0 x 18mm stent

PLATINUM QCA Trial in PerspectivePLATINUM QCA Trial in PerspectiveLa

te L

oss

(m

m)

Late

Loss

(m

m)

SPIRITSPIRITFirstFirst

SPIRITSPIRITFirstFirst

PLATINUMPLATINUMQCAQCA

SPIRITSPIRITIIII

SPIRITSPIRITIIIIII

Increasing Time to Follow-upIncreasing Time to Follow-up

N=23N=23 N=237N=237 N=301N=301 N=73N=73 N=20N=20

6mths6mths 6mths6mths 8mths8mths 9mths9mths 12mths12mths

Promus Element Stent

Promus/Xience Stent

EuroInterv 2010 (in press)EuroInterv 2010 (in press)

PLATINUM QCA Trial (IVUS)PLATINUM QCA Trial (IVUS)Incomplete Stent Apposition (ISA)Incomplete Stent Apposition (ISA)

Performance Goal (SPIRIT III: Promus/Xience)Performance Goal (SPIRIT III: Promus/Xience)

Post-ProcedurePost-ProcedureISAISA

Late-AcquiredLate-AcquiredISAISA

LateLateISAISA

Inco

mple

te S

tent

Apposi

tion (

ISA

) (%

)In

com

ple

te S

tent

Apposi

tion (

ISA

) (%

)

p<0.001p<0.001Promus Element Stent

Promus/Xience Stent

EuroInterv 2010 (in press)EuroInterv 2010 (in press)

All Death, MI, TVRAll Death, MI, TVR 1.0% (1)1.0% (1) 1.0% (1)1.0% (1)

All DeathAll Death 0.0% (0)0.0% (0) 0.0% (0)0.0% (0)

Myocardial InfarctionMyocardial Infarction 0.0% (0)0.0% (0) 0.0% (0)0.0% (0)

Q-waveQ-wave 0.0% (0)0.0% (0) 0.0% (0)0.0% (0)

Non–Q-waveNon–Q-wave 0.0% (0)0.0% (0) 0.0% (0)0.0% (0)

Target Vessel RevascularizationTarget Vessel Revascularization 1.0% (1)1.0% (1) 1.0% (1)1.0% (1)

Target Lesion RevascularizationTarget Lesion Revascularization 1.0% (1)1.0% (1) 1.0% (1)1.0% (1)

Target Lesion FailureTarget Lesion Failure** 1.0% (1)1.0% (1) 1.0% (1)1.0% (1)

Stent Thrombosis Stent Thrombosis (ARC Def/Prob)(ARC Def/Prob) 1.0% (1)1.0% (1) 1.0% (1)1.0% (1)

30 Days30 Days 12 Mths12 Mths

PLATINUM QCA TrialPLATINUM QCA TrialClinical Results Clinical Results (N=100)(N=100)

**Ischemia-driven TLR, or MI/cardiac death related to the target vesselIschemia-driven TLR, or MI/cardiac death related to the target vessel

(All events occurred in the same patient)(All events occurred in the same patient) EuroInterv 2010 (in press)EuroInterv 2010 (in press)

PLATINUMPLATINUM

QCAQCA

PLATINUM WH, SV, LLPLATINUM WH, SV, LL

12M TLF12M TLF

Non-inferiorityNon-inferiority

Single ArmSingle Arm

20 (US & Japan)20 (US & Japan)

102102

Long LesionLong Lesion

12M TLF12M TLF

Historical PROMUS Stent Data from Historical PROMUS Stent Data from SPIRIT TrialsSPIRIT Trials

Non-inferiorityNon-inferiority

Single ArmSingle Arm

20 (US & Japan)20 (US & Japan)

9494

Small VesselSmall Vessel

12M TLF12M TLF

PROMUS StentPROMUS Stent

PROMUS Element StentPROMUS Element Stent

Non-inferiorityNon-inferiority

1:1 Randomized,1:1 Randomized,

Single BlindSingle Blind

160 (Worldwide)160 (Worldwide)

1,5321,532

WorkhorseWorkhorse

10 (IC)10 (IC)# of Sites# of Sites

100100# of Patients# of Patients

30 day cardiac 30 day cardiac eventsevents

Primary Primary EndpointEndpoint

N/AN/AControl StentControl Stent

N/AN/ASuccess Success CriteriaCriteria

PROMUS Element PROMUS Element StentStentTest StentTest Stent

Single ArmSingle ArmTrial DesignTrial Design

Trial/SubtrialTrial/Subtrial

PLATINUM Clinical Program PLATINUM Clinical Program PROMUSPROMUS® ® ELEMENTELEMENT™™ Stent in Stent in de novo de novo lesionslesions

Next Next Generation Generation DESDES

Next Generation DES AttributesNext Generation DES Attributes

No StentNo StentThrombosisThrombosis(‘BMS’ like)(‘BMS’ like)

No StentNo StentThrombosisThrombosis(‘BMS’ like)(‘BMS’ like)

Shortened DAPT Shortened DAPT RequirementRequirement

Shortened DAPT Shortened DAPT RequirementRequirement

Low TLR, Low Low TLR, Low Clinical Symptom Clinical Symptom

RecurrenceRecurrence

Low TLR, Low Low TLR, Low Clinical Symptom Clinical Symptom

RecurrenceRecurrence

Reduced Polymer Reduced Polymer LoadLoad

Ablumenal PolymerAblumenal Polymer

Bioerodable PolymerBioerodable Polymer

No PolymerNo Polymer

Reduced Drug LoadReduced Drug Load

Stent Delivery SystemStent Delivery SystemStent MaterialStent Material

Thinner StrutsThinner Struts

Modified Stent Modified Stent GeometryGeometry

Surface CoatingSurface Coating

Deliverable, Visible, Deliverable, Visible, TrackableTrackable

ConformableConformable

Deliverable, Visible, Deliverable, Visible, TrackableTrackable

ConformableConformable

CostCost

ThrombusThrombus

HemorrhageHemorrhage

DAPTDAPT

The Burden of Stent The Burden of Stent Thrombosis...Thrombosis...

BSC Next Generation DESBSC Next Generation DES

SYNERGYSYNERGY

Everolimus

PLGA

Ultrathin Abluminal, Bioerodable Polymer (Rollcoat Technology)

Element

Bioerodable PLGA polymer Bioerodable PLGA polymer is only applied to the is only applied to the abluminal surface of the abluminal surface of the stentstent

Maximum coating Maximum coating thickness 3thickness 3μμm (1/2 dose) m (1/2 dose) and 4and 4μμm (standard dose)m (standard dose)

SYNERGY StentSYNERGY Stent

Arterial Wall

Current DESCurrent DESConformable DurableConformable Durable

PolymerPolymer

SYNERGY DESSYNERGY DESAbluminal BioerodableAbluminal Bioerodable

PolymerPolymer

Everolimus + Ultra-thin Bioerodable PLGA Polymer appliedEverolimus + Ultra-thin Bioerodable PLGA Polymer applied

to abluminal aspect of a 0.0028” stent strutto abluminal aspect of a 0.0028” stent strut

+6 months+6 months

SYNERGY Relative Polymer ThicknessSYNERGY Relative Polymer Thickness

SYNERGYPolymer(Thickness)

E. Coli(Length)

Red Cell(Diameter)

T. LibertéPolymer(Thickness)

Neutrophil(Diameter)

Mic

ron (

µ)

SYNERGY = Minimal Drug + Ultrathin Bioerodable Abluminal PolymerSYNERGY = Minimal Drug + Ultrathin Bioerodable Abluminal Polymer

μ

Relative Drug Coating WeightsRelative Drug Coating Weights

0 50 100 150 200 250 300 350 500 685 1267

l l l l l l l l l l l

Bare

Meta

lB

are

Meta

l

Coating Weight (Drug + Polymer) (µg/16mm Stent)Coating Weight (Drug + Polymer) (µg/16mm Stent)

//// //

½D½D SDSD

Stent Strut ThicknessStent Strut ThicknessStr

ut

Thic

kness

(in

ches)

Str

ut

Thic

kness

(in

ches)

EVOLVE Synergy stent strut thickness = 0.0032”EVOLVE Synergy stent strut thickness = 0.0032”

EVOLVE Trial - Study FlowEVOLVE Trial - Study Flow

Design Randomized (1:1:1), single-blind, non-inferiority

Test DevicesSYNERGY 56 µg/20mm stent (Low Dose)SYNERGY113 µg/20mm stent ≡ PROMUS Element

Control Device PROMUS Element

Sample Size/Sites291 Patients/Up to 35 Sites in Europe, Australia, & NZ

Primary EndpointComposite safety @ 30D (death, MI, TLR)In-stent Late Loss @ 6M

Additional Analysis IVUS @ Baseline & 6M

Lesion Treatment Single de novo native coronary artery lesions

Lesion Size ≤ 28mm in length, RVD ≥2.25mm - ≤3.5mm

Principal Investigators Ian Meredith & Stephan Verheye

Pati

ents

(N

)Pati

ents

(N

)EVOLVE Trial - RecruitmentEVOLVE Trial - Recruitment

20102010 20112011

UK Investigators

Simon Welsh

Keith Oldroyd

Nick West

Adrian Banning

Rod Stables

Future Growth in Interventional Cardiology is Driven by Segments that are Small Today

Worl

dw

ide IC

Mark

et

($B

)W

orl

dw

ide IC

Mark

et

($B

)

*

*Core = DES, BMS, DEB, Atherectomy, Balloons, Wires, Access, Imaging, & EPI

BSC Internal dataBSC Internal data

$8.3B$8.3B

$10.5B$10.5B

$16.3B$16.3B

+4.8+4.8%%

+8.6%+8.6%

Aortic Stenosis: The Facts…

Untreated Aortic Stenosis has a poor natural history

Many patients are not referred for investigation or treatment

Excellent results for surgical AVR

Superior TAVI results vs. OMT for inoperable patients

Long-term TAVI leaflet durability unknown

Role of TAVI for surgically suitable patients uncertain

Pk Grad = 118.1 mmHg Vmax = 5.43 m/sec

Population Projections Population Projections Office for National Statistics (2008) Office for National Statistics (2008)

Pop

ula

tion ≥

100 y

ears

of

Ag

e (

%)

Pop

ula

tion ≥

100 y

ears

of

Ag

e (

%)

http://www.statistics.gov.uk/downloads/theme_population/NPP2008/NatPopProj2008.pdfhttp://www.statistics.gov.uk/downloads/theme_population/NPP2008/NatPopProj2008.pdf

699,000 (0.8%)699,000 (0.8%)

At Least 30% of Patients with Severe At Least 30% of Patients with Severe Symptomatic Aortic Stenosis are Untreated…Symptomatic Aortic Stenosis are Untreated…

Bouma1999

lung2003

Pellikka2005

Charlson2006

Bach2009

Spokane(Prelim)

Vannan(In press)

Under treatment is especially prevalent among patients Under treatment is especially prevalent among patients managed by Primary Care Physiciansmanaged by Primary Care Physicians

Modified from Kodali, TCT 2010Modified from Kodali, TCT 2010

Euro Heart SurveyEuro Heart SurveyFactors Associated with the Absence of Factors Associated with the Absence of Aortic Valve InterventionAortic Valve Intervention

Х2 p OR [95% CI]

Age >70 years 26.0 0.0001 3.4 [2.1-5.5]

LVEF <60% 14.1 0.0002 2.5 [1.6-4.2]

CHF on Admission 11.6 0.0007 2.8 [1.6-5.1]

NYHA Class 1-II vs. III-IV 6.4 0.01 2.2 [1.2-3.9]

>1 Co-morbidity 6.2 0.01 1.8 [1.1-3.0

Modified from Kodali, TCT 2010Modified from Kodali, TCT 2010Eur Heart J 2003;24:1231-1243Eur Heart J 2003;24:1231-1243

TAVI: Procedure SuccessTAVI: Procedure SuccessPerc

ent

(%)

Perc

ent

(%)

Meredith, TCT 2009; Avanzas Rev Esp Cardiol 2010;63:141-148Meredith, TCT 2009; Avanzas Rev Esp Cardiol 2010;63:141-148Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010

Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010Leon, N Engl J Med 2010;363:1597-1607Leon, N Engl J Med 2010;363:1597-1607

N=62N=62 N=108N=108 N= 66N= 66 N=119N=119 N=588N=588 N= 460N= 460 N= 772N= 772 N= 179N= 179

PA

RTN

ER

B

TAVI: 30-Day All-Cause MortalityTAVI: 30-Day All-Cause MortalityPerc

ent

(%)

Perc

ent

(%)

Meredith, TCT 2009; Avanzas Rev Esp Cardiol 2010;63:141-148Meredith, TCT 2009; Avanzas Rev Esp Cardiol 2010;63:141-148Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010

Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010Leon, N Engl J Med 2010;363:1597-1607Leon, N Engl J Med 2010;363:1597-1607

N=62N=62 N=108N=108 N= 66N= 66 N=119N=119 N=588N=588 N= 460N= 460 N= 772N= 772 N= 179N= 179

PA

RTN

ER

B

TAVI: 30-Day Stroke RateTAVI: 30-Day Stroke RatePerc

ent

(%)

Perc

ent

(%)

Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010

Leon, N Engl J Med 2010;363:1597-1607Leon, N Engl J Med 2010;363:1597-1607

N= 66N= 66 N=119N=119 N=588N=588 N= 460N= 460 N= 772N= 772 N= 179N= 179

PA

RTN

ER

B

TAVI: Pooled Monitored StudiesTAVI: Pooled Monitored StudiesChanges in AR Grade with TimeChanges in AR Grade with Time

Modified from Kodali, TCT 2010Modified from Kodali, TCT 2010

25% of TAVI Recipients have ≥2+ AR at 24 months25% of TAVI Recipients have ≥2+ AR at 24 months

Pati

ents

(%

)Pati

ents

(%

)

TAVI Displacement (Dislocation)TAVI Displacement (Dislocation)30

-Day M

ort

alit

y (

%)

30

-Day M

ort

alit

y (

%)

p=0.024p=0.024

Circ Cardiovasc Interv 2010;3:531-536Circ Cardiovasc Interv 2010;3:531-536

21/212 191/212

In an experienced centre, CoreValve dislocation during TAVI occurred in10% of cases and significantly increased peri-procedural risk for severe complications and death

DisplacementDisplacement No Displacement

Sadra Medical Inc

Founded 2004. Start-up company

Headquarters: Los Gatos CA

Acquired by Boston Scientific (November 19, 2010)

FHU Feasibility Trial (EU) Completed 2010

First Lotus™ Valve: >3 year follow-up

CE-Mark Trial to commence 2011(Australia, Germany, UK)

http://www.sadramedical.comhttp://www.sadramedical.com

The Lotus™ Valve

Pre-loaded Valve

18F Delivery System

23mm & 27mm Diameter

Accurate Placement & Repositionable

True Retrievability

Negligible Aortic Regurgitation

Deploy RetrieveDeploy Retrieve

ReleaseRelease

AtritechAtritech

Founded in 2000. Early commercial company

Headquarters Minneapolis MN

Acquired by BSC ( January 19, 2011)

Watchman LAA Closure Device (CE-Mark 2005)

http://www.atritech.nethttp://www.atritech.net

NEJM 2009;360:2601-2602

LAA occlusion for patients intolerant or unsuitable for warfarin or newer anticoagulants (bleeding risk, poor control)

Watchman implant undertaken by electrophysiologists or interventional cardiologists

Implant as a stand-alone procedure or at the time of AF ablation

Conclusions

BSC has a robust product pipeline and is BSC has a robust product pipeline and is midway through a period of transformation midway through a period of transformation (restructuring, acquisitions and divestitures)(restructuring, acquisitions and divestitures)

The SYNERGY stent will build on the ELEMENT The SYNERGY stent will build on the ELEMENT stent platform, delivering abluminal stent platform, delivering abluminal everolimus via a bioerodable polymereverolimus via a bioerodable polymer

The LotusThe Lotus™™ valve and the Watchman valve and the Watchman device device offer significant diversification and growth offer significant diversification and growth opportunities within the BSC core cardiology opportunities within the BSC core cardiology portfolioportfolio