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Keith Dawkins MD FRCP FACC FSCAI Chief Medical Officer Senior Vice President Boston Scientific Corporation Boston Scientific Programme Update London –

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Presentation on theme: "Keith Dawkins MD FRCP FACC FSCAI Chief Medical Officer Senior Vice President Boston Scientific Corporation Boston Scientific Programme Update London –"— Presentation transcript:

1 Keith Dawkins MD FRCP FACC FSCAI Chief Medical Officer Senior Vice President Boston Scientific Corporation Boston Scientific Programme Update London – January 26, 2011

2 Conflicts of Interest Employee Boston Scientific Corporation Stockholder Boston Scientific Corporation

3 Element Stent Platform Next Generation DES BSC Structural Heart Programme Sadra Lotus ™ Valve Atritech Watchman  Device

4 Element Stent Platform Geometry designed for drug delivery Four stent models Consistent surface-to-artery ratios Apex ™ balloon Bi-component balloon Multilayer Platinum Chromium Alloy Thin struts Radio-opaque Low recoil High radial strength

5 Platinum Chromium (Element Stent) Chromium18% Platinum * 33% Iron37% Nickel9% Manganese0.05% Molybdenum2.6% * Platinum fully incorporated in the alloy (not coating)

6 Comparative Radial Strength Radial Fore (Newtons/mm) Xience V Endeavor Xience Prime Cypher Taxus Liberté Taxus Element Cobalt Chrome Stainless Steel PlatinumChrome Platinum Chrome has 36% less Recoil than Cobalt Chrome

7 Comparative Stent Recoil Percent (%) Recoil Xience V Endeavor Xience Prime Cypher Taxus Liberté Taxus Element Cobalt Chrome Stainless Steel PlatinumChrome Platinum Chrome has 70% more Radial Strength than Cobalt Chrome

8 Taxus Liberté Stent Strut Thickness (µm) Taxus Express Taxus Element Average Bend Cycles before Fracture (million) Fracture Resistance (Bend Fatigue) Taxus Element has Thinner Struts and Higher Fracture Resistance 306x

9 Comparative Drug Load Drug Weight (μg) *PromusElementCypherEndeavorResoluteBioMatrixBioFreedom *Drug Load 3.0 x 18mm stent

10 PLATINUM QCA Trial in Perspective Late Loss (mm) SPIRITFirstSPIRITFirstPLATINUMQCASPIRITIISPIRITIII Increasing Time to Follow-up N=23 N=237N=301 N=73 N=20 6mths6mths8mths9mths12mths Promus Element Stent Promus/Xience Stent EuroInterv 2010 (in press)

11 PLATINUM QCA Trial (IVUS) Incomplete Stent Apposition (ISA) Performance Goal (SPIRIT III: Promus/Xience) Post-ProcedureISALate-AcquiredISALateISA Incomplete Stent Apposition (ISA) (%) p<0.001 Promus Element Stent Promus/Xience Stent EuroInterv 2010 (in press)

12 All Death, MI, TVR 1.0% (1) All Death 0.0% (0) Myocardial Infarction 0.0% (0) Q-wave Non–Q-wave Target Vessel Revascularization 1.0% (1) Target Lesion Revascularization Target Lesion Revascularization 1.0% (1) Target Lesion Failure * 1.0% (1) Stent Thrombosis (ARC Def/Prob) 1.0% (1) 30 Days 12 Mths PLATINUM QCA Trial Clinical Results (N=100) * Ischemia-driven TLR, or MI/cardiac death related to the target vessel (All events occurred in the same patient) EuroInterv 2010 (in press)

13 PLATINUMQCA PLATINUM WH, SV, LL 12M TLF Non-inferiority Single Arm 20 (US & Japan) 102 Long Lesion 12M TLF Historical PROMUS Stent Data from SPIRIT Trials Non-inferiority Single Arm 20 (US & Japan) 94 Small Vessel 12M TLF PROMUS Stent PROMUS Element Stent Non-inferiority 1:1 Randomized, Single Blind 160 (Worldwide) 1,532 Workhorse 10 (IC) # of Sites 100 # of Patients 30 day cardiac events Primary Endpoint N/A Control Stent N/A Success Criteria PROMUS Element Stent Test Stent Single Arm Trial Design Trial/Subtrial PLATINUM Clinical Program PROMUS ® ELEMENT ™ Stent in de novo lesions

14 Next Generation DES

15 Next Generation DES Attributes No Stent Thrombosis (‘BMS’ like) No Stent Thrombosis (‘BMS’ like) Shortened DAPT Requirement Low TLR, Low Clinical Symptom Recurrence Reduced Polymer Load Ablumenal Polymer Bioerodable Polymer No Polymer Reduced Drug Load Stent Delivery System Stent Material Thinner Struts Modified Stent Geometry Surface Coating Deliverable, Visible, TrackableConformable TrackableConformable

16 Cost Thrombus Hemorrhage DAPT The Burden of Stent Thrombosis...

17 BSC Next Generation DES SYNERGY Everolimus PLGA Ultrathin Abluminal, Bioerodable Polymer (Rollcoat Technology) Element Bioerodable PLGA polymer is only applied to the abluminal surface of the stent Maximum coating thickness 3 μ m (1/2 dose) and 4 μ m (standard dose)

18 SYNERGY Stent Arterial Wall Current DES Current DES Conformable Durable Polymer SYNERGY DES SYNERGY DES Abluminal Bioerodable Polymer Everolimus + Ultra-thin Bioerodable PLGA Polymer applied to abluminal aspect of a ” stent strut to abluminal aspect of a ” stent strut +6 months

19 SYNERGY Relative Polymer Thickness SYNERGY Polymer (Thickness) E. Coli (Length) Red Cell (Diameter) T. Liberté Polymer (Thickness) Neutrophil (Diameter) Micron (µ) SYNERGY = Minimal Drug + Ultrathin Bioerodable Abluminal Polymer μ

20 Relative Drug Coating Weights l l l l l l l l l l l Bare Metal BioMatrixPromus T. Liberté Coating Weight (Drug + Polymer) (µg/16mm Stent) // Nevo SYNERGY ½DSD

21 Stent Strut Thickness Strut Thickness (inches) EVOLVE Synergy stent strut thickness = ”

22 EVOLVE Trial - Study Flow DesignRandomized (1:1:1), single-blind, non-inferiority Test Devices SYNERGY 56 µg/20mm stent (Low Dose) SYNERGY113 µg/20mm stent ≡ PROMUS Element Control DevicePROMUS Element Sample Size/Sites291 Patients/Up to 35 Sites in Europe, Australia, & NZ Primary Endpoint Composite 30D (death, MI, TLR) In-stent Late 6M Additional Baseline & 6M Lesion TreatmentSingle de novo native coronary artery lesions Lesion Size≤ 28mm in length, RVD ≥2.25mm - ≤3.5mm Principal InvestigatorsIan Meredith & Stephan Verheye

23 Patients (N) EVOLVE Trial - Recruitment UK Investigators Simon Welsh Keith Oldroyd Nick West Adrian Banning Rod Stables

24 Future Growth in Interventional Cardiology is Driven by Segments that are Small Today Worldwide IC Market ($B) * * Core = DES, BMS, DEB, Atherectomy, Balloons, Wires, Access, Imaging, & EPI BSC Internal data $8.3B $10.5B $16.3B +4.8% +8.6%

25 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 = mmHg Vmax = 5.43 m/sec

26 Population Projections Office for National Statistics (2008) Population ≥100 years of Age (%) 699,000 (0.8%)

27 At Least 30% of Patients with Severe Symptomatic Aortic Stenosis are Untreated… Bouma 1999 lung 2003 Pellikka 2005 Charlson 2006 Bach 2009 Spokane (Prelim) Vannan (In press) Under treatment is especially prevalent among patients managed by Primary Care Physicians Modified from Kodali, TCT 2010

28 Euro Heart Survey Factors Associated with the Absence of Aortic Valve Intervention Х2Х2 pOR [95% CI] Age >70 years [ ] LVEF <60% [ ] CHF on Admission [ ] NYHA Class 1-II vs. III-IV [ ] >1 Co-morbidity [ Modified from Kodali, TCT 2010 Eur Heart J 2003;24:

29 TAVI: Procedure Success Percent (%) Meredith, TCT 2009; Avanzas Rev Esp Cardiol 2010;63: Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010 Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010 Leon, N Engl J Med 2010;363: N=62 N=108 N= 66 N=119N=588 N= 460 N= 772 N= 179 PARTNER B

30 TAVI: 30-Day All-Cause Mortality Percent (%) Meredith, TCT 2009; Avanzas Rev Esp Cardiol 2010;63: Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010 Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010 Leon, N Engl J Med 2010;363: N=62 N=108 N= 66 N=119N=588 N= 460 N= 772 N= 179 PARTNER B

31 TAVI: 30-Day Stroke Rate Percent (%) Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010 Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010 Leon, N Engl J Med 2010;363: N= 66 N=119N=588 N= 460 N= 772 N= 179 PARTNER B

32 TAVI: Pooled Monitored Studies Changes in AR Grade with Time Modified from Kodali, TCT % of TAVI Recipients have ≥2+ AR at 24 months Patients (%)

33 TAVI Displacement (Dislocation) 30-Day Mortality (%) p=0.024 Circ Cardiovasc Interv 2010;3: / /212 In an experienced centre, CoreValve dislocation during TAVI occurred in10% of cases and significantly increased peri-procedural risk for severe complications and death DisplacementNo Displacement

34 Sadra Medical Inc Founded 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)

35 The Lotus ™ Valve Pre-loaded Valve 18F Delivery System 23mm & 27mm Diameter Accurate Placement & Repositionable True Retrievability Negligible Aortic Regurgitation Deploy Retrieve Release

36 Atritech Founded in Early commercial company Headquarters Minneapolis MN Acquired by BSC ( January 19, 2011) Watchman  LAA Closure Device (CE-Mark 2005)

37 NEJM 2009;360: 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

38 Conclusions BSC has a robust product pipeline and is midway through a period of transformation (restructuring, acquisitions and divestitures) The SYNERGY stent will build on the ELEMENT stent platform, delivering abluminal everolimus via a bioerodable polymer The Lotus ™ valve and the Watchman  device offer significant diversification and growth opportunities within the BSC core cardiology portfolio


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