NEUROVASCULAR CARDIAC RHYTHM MANAGEMENT ELECTROPHYSIOLOGY INTERVENTIONAL BRONCHOSCOPY GYNECOLOGY UROLOGY

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1 Boston Scientific ELEMENT Drug-Eluting Stent Program Keith Dawkins MD FRCP FACC FSCAI Chief Medical Officer Senior Vice President Boston Scientific Corporation

2 BSC Core Business Coronary Stents 23% CRM 30% Neurovascular 4% Neuromodulation 3% PI 8% Endo 18% IC 12% EP 2% Source: BSC Internal Data

3 Boston Scientific - Advancing patient care across a broad range of medical specialties INTERVENTIONAL RADIOLOGY INTERVENTIONAL CARDIOLOGY PAIN MANAGEMENT NEUROVASCULAR CARDIAC RHYTHM MANAGEMENT ELECTROPHYSIOLOGY GASTROENTEROLOGY INTERVENTIONAL BRONCHOSCOPY ONCOLOGY GYNECOLOGY PERIPHERAL VASCULAR UROLOGY

4 Research & Development Spend ($M) $ (millions) Year Source: BSC Internal Data

5 Why do Interventional Cardiologists use a particular Stent? Sales Marketing Cost Hospital Administrator Safety Competition Data Performance Hospitality

6 PCI Outcomes are Improving with Time Event Rate (%) POBA POBA BMS BMS DES DES (1977) (1985) (1994) (1997) (2003) (2009) Modified from Don Baim (FDA Panel 2006)

7 Requirements of the ideal DES Efficacy Safety Deliverability Cost

8 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

9 TAXUS Stent Design TAXUS Express Diam: mm Stent Designs: 2 (WH + LV) TAXUS Liberté Diam: mm Stent Designs: 3 (SV + WH + LV) TAXUS Element Diam: mm Stent Designs: 4 (SV + SWH + WH + LV) Allows for more consistent drug delivery across diameter range

10 Taxus Express 2 Taxus Liberté Taxus Element

11 Element SV (2.25) Element SWH (2.50,2.75) Element WH (3.00,3.50) Element LV (4.00,4.50) Element Stent Designs

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

13 Stent Nickel Content Nickel Composition (by weight (%) Driver, Endeavor Taxus, Cypher Promus Element MP35N (MDT) Cobalt-ChromeChrome 316L Stainless steel L605 (ABT) Cobalt-ChromeChrome Platinum Chrome Platinum chrome has the lowest Nickel content of the available alloys

14 Comparative Density Density (gm/cc) Stainless Steel (316L) Element Platinum Chrome Cobalt Chromium

15 Comparative Trackability * Force Element Platinum Chromium Cobalt Chromium * Trackability: Measures the ability of the stent delivery system to maneuver through a tortuous artery model. Lower forces indicate increased trackability and greater distal segment flexibility.

16 Comparative Recoil * Percent Stainless steel Element Platinum Chromium Cobalt Chromium * Recoil: The percentage that the stent diameter decreases after balloon deflation. Lower recoil maintains better vessel lumen diameter after the balloon is deflated and withdrawn.

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

18 BSC Two Drug Strategy Paclitaxel Everolimus Element Stent Element Stent Trial Complete N=1488 Trial Complete N=1828

19 BSC Two Drug Strategy Paclitaxel Everolimus Element Stent Direct Drug comparison on the same ELEMENT Platform

20 Next Generation DES

21 Next Generation DES Attributes Deliverable, Visible, Trackable Conformable 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

22 Very Late DES Thrombosis (VLST) 3.0mm x 28mm DES (25 months)

23 Impact of Bleeding on Anti-Platelet Compliance after DES Implantation Bleeding Type Nuisance (85.7%) Internal (13.6%) Alarming (0.7%) Meds Discontinued (%) 10% Nuisance Internal N=837/2360 (32.4%) with bleeding Am J Cardiol 2008;102:

24 BSC Next Generation DES Labcoat Paclitaxel PLA Ultrathin Abluminal, Bioerodable Polymer ( Dot Technology) Liberté Evolution Everolimus PLGA Ultrathin Abluminal, Bioerodable Polymer (Rollcoat Technology) Element

25 Everolimus Release Kinetics 60 SYNERGY Ev Cumulative Release (mg) In vitro KDR In vivo release In vitro KDR In vivo release PROMUS (in vivo) SYNERGY LD Time (days)

26 SYNERGY Stent Bioerodable polymer is only applied to the abluminal surface of the stent Maximum coating thickness 3μm (low dose) and 4μm (high dose)

27 SYNERGY Stent Current DES Conformable Durable Polymer SYNERGY DES Abluminal Bioerodable Polymer +3 months Arterial Wall Everolimus + Ultra-thin thin Bioerodable PLGA Polymer applied to abluminal aspect of a stent strut

28 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 (µg, 16mm Stent) // // //

29 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

30 Stent Strut Thickness Strut Thickness (inches) Cypher Express Liberté Driver Vision Element Synergy

31 BSC Two Drug Strategy Paclitaxel Everolimus Next Generation DES Low Drug Dose, Ablumenal Delivery, Bioerodable Polymer? Short DAPT Trial Complete N=103 Labcoat Liberté SYNERGY Trial to commence Q2 2010

32 EVOLVE Trial - Study Flow Design Test Devices Control Device Sample Size/Sites Primary Endpoint Additional Analysis Lesion Treatment Lesion Size Principal Investigators Randomized (1:1:1), single-blind, non-inferiority SYNERGY 56 µg/20mm stent (Low Dose) SYNERGY113 µg/20mm stent PROMUS Element PROMUS Element 291 Patients/Up to 35 Sites in Europe, Australia, & NZ Composite 30D (death, MI, TLR) In-stent Late 6M Baseline & 6M Single de novo native coronary artery lesions 28mm in length, RVD 2.25mm - 3.5mm Ian Meredith & Stephan Verheye

33 Conclusions: The BSC DES pipeline is robust Unique Two Drug position (Paclitaxel + Everolimus) pursued through the Element Program PERSEUS (Taxus Element) reported at ACC 2010 (LBT), and PLATINUM (Promus Element) Trial at ACC 2011 (QCA/IVUS at TCT 2010) Next generation Promus Element launched in Europe, Middle East, Asia (2010 Q1), Taxus Element in Q SYNERGY, ultrathin abluminal bioerodable polymer loaded stents under clinical evaluation (EVOLVE Trial commences 2010 Q2) Further significant investments in the cardiovascular space anticipated