WATCHMAN Left Atrial Appendage Closure Device Investor...

1

WATCHMAN™

Left Atrial Appendage Closure Device

Investor Update

March 15, 2015

2 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015

Safe Harbor for Forward-Looking Statements

This presentation contains forward-looking statements within the meaning of Section

27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of

1934. Forward-looking statements may be identified by words like “anticipate,”

“expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These

forward-looking statements are based on our beliefs, assumptions and estimates using

information available to us at the time and are not intended to be guarantees of future

events or performance. If our underlying assumptions turn out to be incorrect, or if

certain risks or uncertainties materialize, actual results could differ materially from the

expectations and projections expressed or implied by our forward-looking statements.

Factors that may cause such differences can be found in our most recent Form 10-K

and Forms 10-Q filed or to be filed with the Securities and Exchange Commission

under the headings “Risk Factors” and “Safe Harbor for Forward-Looking Statements.”

Accordingly, you are cautioned not to place undue reliance on any of our forward-

looking statements. We disclaim any intention or obligation to publicly update or revise

any forward-looking statements to reflect any change in our expectations or in events,

conditions, or circumstances on which they may be based, or that may affect the

likelihood that actual results will differ from those contained in the forward-looking

statements.

3

Joe Fitzgerald Executive Vice President and President,

Rhythm Management

Kenneth Stein, M.D. Chief Medical Officer,

Rhythm Management


WATCHMAN™ Left Atrial Appendage Closure Device

FDA Approved!

• First-of-its-kind device

• New option for U.S. patients

• Extensively studied:

• over 2,400 patients

• ~6,000 patient years of follow-up

• Registered in 75 countries

• Over 10,000 implants worldwide


WATCHMAN™ Device Global Market Opportunity

~15 million patients with atrial fibrillation

~7.5 million with CHADS2 ≥ 2

~2.5 million target patients

~50,000 procedures /

year

~50% with CHADS2 score ≥ 2

~2-4% annual prevalence

penetration

~$500M Source: BSC Estimates

~30-40% have reasons to seek alternative

global market opportunity by 2019


*OAT = Oral Anticoagulant Therapy; **NOAC = Novel Oral Anti-Coagulant

1 Go AS. et al, Heart Disease and Stroke Statistics—2013 Update: A Report From the American Heart Association. Circulation. 2013; 127: e6-e245

2 Jani, et al. Uptake of Novel Oral Anticoagulants in Patients with Non-Valvular and Valvular Atrial Fibrillation: Results from the NCDR-Pinnacle Registry. ACC 2014

3 Connolly, S. NEJM 2009; 361:1139-1151 – 2 years f-up (Corrected)

4 Patel, M. NEJM 2011; 365:883-891 – 1.9 years f-up, ITT

5 Granger, C NEJM 2011; 365:981-992 – 1.8 years f-u

6 BSC Estimates

WATCHMAN™ Device U.S. Market Opportunity

• 5 million Americans with atrial fibrillation, 50% with CHADS2 ≥ 21

• ~40% of patients indicated for OAT* do not take an OAT of any kind2

• >20% of patients in NOAC** trials discontinued drug within 2 years3,4,5

• Competitive device with stroke indication unlikely for at least 4 years


WATCHMAN™ Device Indications for Use

The WATCHMAN Device is indicated to reduce the risk of

thromboembolism from the left atrial appendage in patients with non-

valvular atrial fibrillation who:

– Are at increased risk for stroke and systemic embolism based on

CHADS2 or CHA2DS2-VASc scores and are recommended for

anticoagulation therapy;

– Are deemed by their physicians to be suitable for warfarin; and

– Have an appropriate rationale to seek a non-pharmacologic

alternative to warfarin, taking into account the safety and effectiveness

of the device compared to warfarin

8 Boston Scientific Confidential – WATCHMAN Left Atrial Appendage Closure Device Investor Update – March 15, 2015

WATCHMAN™ Device Patient Selection Considerations

– a history of major bleeding while

taking therapeutic anticoagulation

therapy

– the patient’s prior experience with

oral anticoagulation (if

applicable),

– a medical condition, occupation,

or lifestyle placing the patient at

high risk of major bleeding

secondary to trauma.

– the presence of indication(s) for

long-term warfarin use, other

than non-valvular atrial fibrillation

– overall medical status

– suitability for percutaneous,

trans-septal procedures

– ability to comply with the

recommended post-WATCHMAN

Device implant pharmacologic

regimen

Rationale for seeking an

alternative to warfarin:

Factors to consider for

WATCHMAN implantation :


WATCHMAN™ Device U.S. Launch Plan

• Cadenced launch to ensure positive patient

outcomes

• Available to clinical study sites and additional,

specialized centers the first year post approval

• Speed of rollout limited by number of qualified

physician trainers and BSC clinical specialists

• Ample supply to meet rollout plan


WATCHMAN™ Device Physician Training Program

Online Training

Phase 1 Phase 2 Phase 3+

Live professional

training with

physician faculty

Cadence of cases

supported by

clinical specialists

and optional

proctoring


WATCHMAN™ Device Reimbursement

• Coding and Payment rates in place: DRG 250 and 251

• Proactively working with CMS and societies on coverage pathway

• Exploring both local and national coverage options

• Applied for New Technology Add-on Payment for 2015

REIMBURSEMENT = Coding + Coverage + Payment Rates


Next Generation Device: WATCHMAN FLX™

• Design enhancements:

• Closed distal end with fluoro marker

• Full recapture & redeployment

• Expanded LAA treatment range

• Conformable frame design

• Expect EU approval, market evaluation, & full launch by Q415

• United States clinical evaluation to start early 2016

Pending CE Mark, not available for sale in the European Economic Area


• FDA approval post market study

• Contra-indicated patients study

• WATCHMAN FLX™ clinical evaluation in the United States

WATCHMAN™ Device Future Studies

14

Vivek Reddy, M.D. Director of the Cardiac Arrhythmia Service

Mount Sinai Medical Center


WATCHMAN™ Device: Addresses Unmet Medical Need

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2011Q1

2011Q2

2011Q3

2011Q4

2012Q1

2012Q2

2012Q3

2012Q4

Total on Oral

Anticoagulation

Warfarin

NOACs

Anticoagulant Use in Patients with

NVAF and CHADS2 ≥ 2

n=25719 n=29194 n=31582 n=36490 n=67102 n=70667 n=70320 n=71396

Source: Jani, et al. Uptake of Novel Oral Anticoagulants in Patients with Non-Valvular and Valvular Atrial Fibrillation: Results from the NCDR-Pinnacle Registry. ACC 2014.


Less Anticoagulation Use in Higher Risk Patients

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5 6

CHADS2 Score

p < 0.001

(n=27,164)

AF

Pati

en

ts U

sin

g

An

tico

ag

ula

tio

n

Anticoagulation Use Declines with

Increased Stroke Risk1

1. Piccini, et al., Pharmacotherapy in Medicare beneficiaries with atrial fibrillation. Heart Rhythm. 2012; 9:1403-1408


OAT Discontinuation and Risk of Major Bleeds

1 Connolly, S. NEJM 2009; 361:1139-1151 – 2 years f-up (Corrected)

2 Patel, M. NEJM 2011; 365:883-891 – 1.9 years f-up, ITT

3 Granger, C NEJM 2011; 365:981-992 – 1.8 years f-u

4 Giugliano, R. NEJM 2013; 369(22): 2093-2104 – 2.8 years follow-up.

Treatment

Study Drug

Discontinuation Rate

Major Bleeding

(rate/year)

Rivaroxaban1 24% 3.6%

Apixaban2 25% 2.1%

Dabigatran3

(150 mg) 21% 3.3%

Edoxaban4

(60 mg / 30 mg) 33 % / 34% 2.8% / 1.6%

Warfarin1-4 17 – 28% 3.1 – 3.6%


• Higher bleeding risk / older patients

• Previous falls or fall risk

• Prior stroke / TIA while on warfarin

• Inability to adhere with pharmacologic therapy

• High risk of injury occupations / activities

WATCHMAN™ Device Patient Candidates

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