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Keith Dawkins MD FRCP FACC FSCAI Chief Medical Officer Senior Vice President Boston Scientific Corporation PowerPoint Presentation
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Boston Scientific Programme Update. Keith Dawkins MD FRCP FACC FSCAI Chief Medical Officer Senior Vice President Boston Scientific Corporation. London – January 26, 2011. Conflicts of Interest. Employee Boston Scientific Corporation Stockholder Boston Scientific Corporation.

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slide1

Boston Scientific

Programme Update

Keith Dawkins MD FRCP FACC FSCAI

Chief Medical Officer

Senior Vice President

Boston Scientific Corporation

London – January 26, 2011

conflicts of interest
Conflicts of Interest
  • Employee
    • Boston Scientific Corporation
  • Stockholder
    • Boston Scientific Corporation
slide3
Element Stent Platform
  • Next Generation DES
  • BSC Structural Heart Programme
    • Sadra Lotus™ Valve
    • Atritech Watchman Device
element stent platform
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

platinum chromium element stent
Platinum Chromium (Element Stent)

Chromium

18%

Nickel

9%

Platinum*

33%

Molybdenum

2.6%

Iron

37%

*Platinum fully incorporated in the alloy (not coating)

Manganese

0.05%

comparative radial strength
Comparative Radial Strength

Radial Fore (Newtons/mm)

Xience V

Endeavor

Cypher

Taxus Liberté

Taxus Element

Xience Prime

Platinum

Chrome

Stainless Steel

Cobalt Chrome

Platinum Chrome has 36% less Recoil than Cobalt Chrome

comparative stent recoil
Comparative Stent Recoil

Percent (%) Recoil

Xience V

Endeavor

Xience Prime

Cypher

Taxus Liberté

Taxus Element

Platinum

Chrome

Stainless Steel

Cobalt Chrome

Platinum Chrome has 70% more Radial Strength than Cobalt Chrome

fracture resistance bend fatigue
Fracture Resistance (Bend Fatigue)

306x

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

comparative drug load
Comparative Drug Load

Drug Weight (μg)*

Promus

Element

Cypher

Endeavor

Resolute

BioMatrix

BioFreedom

*Drug Load 3.0 x 18mm stent

platinum qca trial in perspective
PLATINUM QCA Trial in Perspective

Promus Element Stent

Promus/Xience Stent

Late Loss (mm)

N=23

N=237

N=301

N=20

N=73

SPIRIT

First

SPIRIT

II

SPIRIT

III

PLATINUM

QCA

SPIRIT

First

6mths

6mths

8mths

9mths

12mths

Increasing Time to Follow-up

EuroInterv 2010 (in press)

platinum qca trial ivus incomplete stent apposition isa
PLATINUM QCA Trial (IVUS)Incomplete Stent Apposition (ISA)

Promus Element Stent

Promus/Xience Stent

Performance Goal (SPIRIT III: Promus/Xience)

p<0.001

Incomplete Stent Apposition (ISA) (%)

Post-Procedure

ISA

Late-Acquired

ISA

Late

ISA

EuroInterv 2010 (in press)

platinum qca trial clinical results n 100
PLATINUM QCA TrialClinical Results (N=100)

30 Days

12 Mths

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

(All events occurred in the same patient)

EuroInterv 2010 (in press)

platinum clinical program promus element stent in de novo lesions
PLATINUM Clinical Program PROMUS® ELEMENT™Stent in de novo lesions

PLATINUM WH, SV, LL

PLATINUM

QCA

Trial/Subtrial

Workhorse

Small Vessel

Long Lesion

# of Patients

1,532

94

102

100

# of Sites

160 (Worldwide)

20 (US & Japan)

20 (US & Japan)

10 (IC)

Trial Design

1:1 Randomized,

Single Blind

Single Arm

Single Arm

Single Arm

Success Criteria

Non-inferiority

Non-inferiority

Non-inferiority

N/A

Test Stent

PROMUS Element Stent

PROMUS Element Stent

Control Stent

PROMUS Stent

Historical PROMUS Stent Data from SPIRIT Trials

N/A

Primary Endpoint

12M TLF

12M TLF

12M TLF

30 day cardiac events

slide15

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
the burden of stent thrombosis
The Burden of Stent Thrombosis...

Thrombus

Cost

DAPT

Hemorrhage

slide17

BSC Next Generation DES

  • Bioerodable PLGA polymer is only applied to the abluminal surface of the stent
  • Maximum coating thickness 3μm (1/2 dose) and 4μm (standard dose)
synergy stent
SYNERGY Stent

SYNERGY DES

Abluminal Bioerodable

Polymer

Current DES

Conformable Durable

Polymer

+6 months

Arterial Wall

Everolimus + Ultra-thin Bioerodable PLGA Polymer applied

to abluminal aspect of a 0.0028” stent strut

synergy relative polymer thickness
SYNERGY Relative Polymer Thickness

Micron (µ)

μ

SYNERGY

Polymer

(Thickness)

E. Coli

(Length)

Red Cell

(Diameter)

T. Liberté

Polymer

(Thickness)

Neutrophil

(Diameter)

SYNERGY = Minimal Drug + Ultrathin Bioerodable Abluminal Polymer

relative drug coating weights
Relative Drug Coating Weights

Bare Metal

Nevo

T. Liberté

BioMatrix

Promus

SYNERGY

½D

SD

//

//

//

l l l l l l l l l l l

0 50 100 150 200 250 300 350 500 685 1267

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

stent strut thickness
Stent Strut Thickness

Strut Thickness (inches)

EVOLVE Synergy stent strut thickness = 0.0032”

Synergy* 0.0029”

Cypher 0.0055”

Express 0.0052”

Element 0.0032”

Liberté 0.0038”

Vision 0.0032”

Driver 0.0036”

slide23

EVOLVE Trial - Recruitment

Patients (N)

2010

2011

future growth in interventional cardiology is driven by segments that are small today
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

aortic stenosis the facts
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 office for national statistics 2008
Population Projections Office for National Statistics (2008)

699,000 (0.8%)

Population ≥100 years of Age (%)

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

at least 30 of patients with severe symptomatic aortic stenosis are untreated
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

euro heart survey factors associated with the absence of aortic valve intervention
Euro Heart SurveyFactors Associated with the Absence of Aortic Valve Intervention

Modified from Kodali, TCT 2010

Eur Heart J 2003;24:1231-1243

tavi procedure success
TAVI: Procedure Success

Percent (%)

PARTNER B

N=62

N= 179

N=108

N= 66

N=119

N=588

N= 460

N= 772

Meredith, TCT 2009; Avanzas Rev EspCardiol 2010;63:141-148

Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010

Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010

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

tavi 30 day all cause mortality
TAVI: 30-Day All-Cause Mortality

Percent (%)

PARTNER B

N=62

N= 179

N=108

N= 66

N=119

N=588

N= 460

N= 772

Meredith, TCT 2009; Avanzas Rev EspCardiol 2010;63:141-148

Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010

Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010

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

tavi 30 day stroke rate
TAVI: 30-Day Stroke Rate

Percent (%)

PARTNER B

N= 179

N= 66

N=119

N=588

N= 460

N= 772

Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010

Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010

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

tavi pooled monitored studies changes in ar grade with time
TAVI: Pooled Monitored StudiesChanges in AR Grade with Time

Patients (%)

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

Modified from Kodali, TCT 2010

tavi displacement dislocation
TAVI Displacement (Dislocation)

p=0.024

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;3:531-536

sadra medical inc
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.com

the lotus valve
The Lotus™ Valve
  • Pre-loaded Valve
  • 18F Delivery System
  • 23mm & 27mm Diameter
  • Accurate Placement & Repositionable
  • True Retrievability
  • Negligible Aortic Regurgitation

Deploy Retrieve

Release

atritech
Atritech
  • 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.net

slide37

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;360:2601-2602

conclusions
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