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Boston Scientific Programme Update Keith Dawkins MD FRCP FACC FSCAI

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Presentation on theme: "Boston Scientific Programme Update Keith Dawkins MD FRCP FACC FSCAI"— Presentation transcript:

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

2 Conflicts of Interest Employee Stockholder
Boston Scientific Corporation Stockholder

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 4

5 Platinum Chromium (Element Stent)
Molybdenum 2.6% Manganese 0.05% Nickel 9% Chromium 18% Iron 37% Platinum* 33% *Platinum fully incorporated in the alloy (not coating)

6 Comparative Radial Strength
Radial Fore (Newtons/mm) Xience V Xience Prime Endeavor Cypher Taxus Liberté Taxus Element Platinum Chrome Cobalt Chrome Stainless Steel 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 Platinum Chrome Cobalt Chrome Stainless Steel Platinum Chrome has 70% more Radial Strength than Cobalt Chrome

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

9 Comparative Drug Load Drug Weight (μg)* Promus Element Cypher Endeavor
Resolute BioMatrix BioFreedom *Drug Load 3.0 x 18mm stent

10 PLATINUM QCA Trial in Perspective
Promus Element Stent Promus/Xience Stent Late Loss (mm) N=23 N=237 N=301 N=73 N=20 SPIRIT First SPIRIT II SPIRIT III PLATINUM QCA SPIRIT First Increasing Time to Follow-up 6mths 6mths 8mths 9mths 12mths EuroInterv 2010 (in press)

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

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

13 PLATINUM Clinical Program PROMUS® ELEMENT™ Stent in de novo lesions
QCA PLATINUM WH, SV, LL 12M TLF Non-inferiority Single Arm 20 (US & Japan) 102 Long Lesion Historical PROMUS Stent Data from SPIRIT Trials 94 Small Vessel PROMUS Stent PROMUS Element Stent 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 Success Criteria Test Stent Trial Design Trial/Subtrial Not from Marketing Deck – Trial design slides taken from recently approved in Int’l deck.

14 Next Generation DES

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

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

17 Ultrathin Abluminal, Bioerodable Polymer (Rollcoat Technology)
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 3μm (1/2 dose) and 4μm (standard dose)

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

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

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

21 Strut Thickness (inches)
Stent Strut Thickness Strut Thickness (inches) Express ” Liberté ” Driver ” Element ” Vision ” Cypher ” Synergy* ” EVOLVE Synergy stent strut thickness = ”

22 EVOLVE Trial - Study Flow
Design Randomized (1:1:1), single-blind, non-inferiority Test Devices SYNERGY 56 µg/20mm stent (Low Dose) SYNERGY113 µg/20mm stent ≡ PROMUS Element Control Device PROMUS Element Sample Size/Sites 291 Patients/Up to 35 Sites in Europe, Australia, & NZ Primary Endpoint Composite 30D (death, MI, TLR) In-stent Late 6M Additional Analysis 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

23 EVOLVE Trial - Recruitment
UK Investigators Simon Welsh Keith Oldroyd Nick West Adrian Banning Rod Stables Patients (N) 2010 2011

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

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)
699,000 (0.8%) Population ≥100 years of Age (%)

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
Х2 p OR [95% CI] Age >70 years 26.0 0.0001 3.4 [ ] LVEF <60% 14.1 0.0002 2.5 [ ] CHF on Admission 11.6 0.0007 2.8 [ ] NYHA Class 1-II vs. III-IV 6.4 0.01 2.2 [ ] >1 Co-morbidity 6.2 1.8 [ Modified from Kodali, TCT 2010 Eur Heart J 2003;24:

29 TAVI: Procedure Success
Percent (%) PARTNER B N=62 N=108 N= 66 N=119 N=588 N= 460 N= 772 N= 179 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:

30 TAVI: 30-Day All-Cause Mortality
Percent (%) PARTNER B N=62 N=108 N= 66 N=119 N=588 N= 460 N= 772 N= 179 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:

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

32 TAVI: Pooled Monitored Studies Changes in AR Grade with Time
Patients (%) 25% of TAVI Recipients have ≥2+ AR at 24 months Modified from Kodali, TCT 2010

33 TAVI Displacement (Dislocation)
30-Day Mortality (%) 21/212 191/212 Displacement No Displacement In an experienced centre, CoreValve dislocation during TAVI occurred in10% of cases and significantly increased peri-procedural risk for severe complications and death Circ Cardiovasc Interv 2010;3:

34 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)

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 2000. Early commercial company
Headquarters Minneapolis MN Acquired by BSC ( January 19, 2011) Watchman LAA Closure Device (CE-Mark 2005)

37 Implant as a stand-alone procedure or at the time of AF ablation
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 NEJM 2009;360:

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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