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ST. JUDE MEDICAL
2016 ANALYST AND
INVESTOR MEETING February 5, 2016
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WELCOME AND OPENING REMARKS Mike Rousseau, President and CEO
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This presentation contains forward-looking statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the
expectations, plans and prospects for the Company, including potential clinical successes , reimbursement
strategies, anticipated regulatory approvals and future product launches, and projected revenues, margins,
earnings and market shares. The statements made by the Company are based upon management’s current
expectations and are subject to certain risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company’s control and the risk factors and other cautionary
statements described in the Company’s filings with the SEC, including those described in the Risk Factors
and Cautionary Statements sections of the Company’s Annual Report on Form 10 -K for the fiscal year ended
January 3, 2015 and Quarterly Report on Form 10-Q for the fiscal quarter ended October 3, 2015. The
Company does not intend to update these statements and undertakes no duty to any person to provide any
such update under any circumstance.
The Company will be using non-GAAP financial measures (e.g., constant currency sales growth, adjusted net
earnings, etc.) in this presentation. Investors should consider non-GAAP measures in addition to, and not as a
substitute for, financial performance measures prepared in accordance with GAAP. For a reconciliation of our non-
GAAP financial measures to our GAAP results, please see the Company’s Current Report on Form 8-K furnished
January 27, 2016.
FORWARD-LOOKING STATEMENTS AND DISCLOSURES
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8:00AM Driving Growth Through Innovation
Mike Rousseau, President and Chief Executive Officer
Thoratec Integration: A Priority for 2016
Rachel Ellingson, V.P., Corporate Strategy
Heart Failure: Medical Technology Leadership
Eric Fain, M.D., Group President
John O’Connell M.D., Medical Director, Mechanical Circulatory Support and V.P., Medical Affairs
Panel for Q&A
~10:00AM Break
Atrial Fibrillation: Platform and Pipeline for Global Innovation Leadership
Phil Ebeling, V.P. and Chief Technology Officer
Traditional CRM: A Path to Recovery in the U.S.
Eric Fain M.D., Group President
Neuromodulation: Building the Most Comprehensive Portfolio
Keith Boettiger, Senior V.P. & General Manager, Chronic Pain & Movement Disorder Therapies
Cardiovascular: Products to Watch in 2016
Phil Ebeling, V.P. and Chief Technology Officer
Panel and Q&A
12:00PM Meeting Ends
AGENDA
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QUOTE GUIDE QUOTE GUIDE
QUOTE GUIDE QUOTE GUIDE
OUR COMMITMENT TO CUSTOMERS
Target expensive epidemic disease states by surrounding the patient
care continuum with innovative products that offer clinical and
economic advantages
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Growth
Heart Failure Low/Mid SD
Atrial Fibrillation Low-teens
Neuromodulation Mid/High SD
Traditional CRM Flat
Cardiovascular High-single/Low-teens
OUR MARKETS FOR 2016 EXCEED $23 BILLION IN SIZE AND ARE
GROWING MID SINGLE DIGITS*
>$4B
>$2B
>$4B
~$7B
>$6B
Atrial Fibrillation Neuromodulation
Heart Failure Traditional CRM
Cardiovascular
All dollar market sizes are based on estimated revenues
St. Jude Medical market estimates
* Excludes the impact from currency
Low/Mid SD- Low to middle single digit percent growth
Low-teens - Low teens percent growth
Mid/High SD-Middle to high single digit percent growth
High-single/Low-teens percent growth
Flat ~0%
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Atrial Fibrillation (AF): We understood early on that ultimately curing AF would require a “tool box” approach
Over time, we have created the most comprehensive product portfolio in the industry
Heart Failure: We are on the front lines of developing the multi-billion dollar heart failure device market
We are uniquely able to offer products that improve patient care – from early symptoms to advanced heart failure,
regardless of type
The recent acquisition of Thoratec adds the market leading portfolio of left ventricular assist devices
Neuromodulation: We are the global innovation leader with a portfolio that spans the continuum of care for chronic
pain patients
STJ proprietary SCS Burst therapy* provides superior pain relief vs. tonic for overall, trunk, and limb pain
STJ’s proprietary Dorsal Root Ganglion therapy* is superior to tonic relief for targeted pain syndromes
SURROUNDING DISEASE STATES
7 *Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
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BULLET GUIDE BULLET GUIDE Healthcare remains a largely fee-for-service market
Economic incentives need to change for providers to truly transition to fee-for-value
Industry needs to address both ends of the spectrum
We are living this paradigm with technologies like CardioMEMS/Fractional Flow Reserve (FFR)
We are working with customers during this transition to provide tailored solutions
Markets around the world are evolutionary not revolutionary when it comes to the paradigm shift
from fee-for-service to fee-for-value
ADDRESSING AN EVOLVING HEALTHCARE LANDSCAPE
FFS = fee-for-service / FFV = fee-for-value
FF
S
FF
V
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9
In 2012 we saw: our markets changing, hospitals consolidating, payment models
transitioning, pricing pressures mounting
How can STJ compete and win in that environment?
Target expensive epidemic disease states and deliver innovation to transform treatment in
those markets
Surround patient care continuum with products that offer clinical and economic advantages
Provide solutions to our customers that address their needs in an evolving healthcare
landscape
And transition from a highly decentralized structure to ONE SJM (end of 2012)
Agility being critically important
Resources must be optimized across organization
OUR DECISION TO EVOLVE OUR STRUCTURE
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Aligned priorities ensure global organization focused on the right things
Shared resources across our organization – able to make decisions based on company-wide goals
rather than individual division goals
Faster decision making and ability to course correct – agility is critically important
Operating leverage through global supply chain
Drives increased collaboration and communication without expense of traditional business silos
Cultural alignment – employees working together to achieve our vision and mission
Integration as a competitive advantage
Selling divisions can focus on selling – organized the way customers make purchasing decisions
Contracting resources within selling teams across cardiovascular service line
OUR STRUCTURE SUPPORTS OUR STRATEGY
Functional Centers of
Excellence Geographic and Key
Accounts Sales Teams
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Atrial Fibrillation:
Addressed ablation catheter gap and now adding a highly competitive advanced mapping
system with a full set of tools
EnSite Precision* – 18 months from development to launch
FlexAbility SE Catheters**
Neuromodulation:
Transformed neuromodulation business through internal investment and acquisitions by
reallocating significant resources
Launching most comprehensive portfolio in 2016
Heart Failure:
Identified challenges in treatment paradigm and invested resources to become medical
technology leader
HeartMate LVAD / CardioMEMS opportunities in 2016; MultiPoint™ Pacing*** for non-
responders
ONE SJM – MANY BENEFITS
*510K pending
**PMA-S pending
****Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
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2016 GOALS
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Establish U.S. reimbursement for CardioMEMS nationwide
Successfully integrate our Thoratec acquisition
Execute the plan for recovery in U.S. CRM
Successfully launch key products to drive sales growth
Where we focus…We win
SETTING MEASURABLE GOALS IN 2016
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We have clear evidence that pulmonary artery pressure-guided heart failure management is
superior to clinical assessment alone
Recent The Lancet publication: 48% reduction in HF hospitalizations at 31 months
CMS established new technology add-on and pass-through pathway payments
We have submitted our application to CMS for a National Coverage Determination
We will also continue to work with national private payers and regional MACs
Our commercial experience has continued to demonstrate strong patient benefits and there is
tremendous support from the implanting community
Clinical evidence continues to grow and outcomes are as good as – or better than – those observed in
CHAMPION
ESTABLISH U.S. REIMBURSEMENT FOR CARDIOMEMS
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Thoratec represents the largest acquisition in the history of St. Jude Medical
Added the broadest portfolio of mechanical circulatory support devices to treat the full
range of clinical needs for patients suffering from advanced heart failure
Integration team and priorities were established early
Appointed an executive sponsor, dedicated senior leader and cross-functional team to ensure
stability within both organizations
Continued business momentum demonstrated with revenue growth and clinical study
execution
A TOP PRIORITY FOR ST. JUDE MEDICAL
HeartMate 3™ System*
HeartMate PHP™ System*
15 *Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
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Upcoming launches will fill product gaps as well as deliver technology advancements
Allow STJ to compete at the premium tier of contract negotiations
Enhanced AF, HF and CRM portfolios provide unique opportunities when contracting with
customers
First half of 2016:
Assurity MRI™ Pacemaker* in the U.S.
MRI labeling for existing ICD’s in Japan
MRI safe Ellipse™ ICD approved on February 2, 2016
Second half of 2016:
Nanostim™ Leadless Pacemaker*
MultiPoint™ Pacing*, advanced diagnostics, next generation Confirm™ insertable cardiac
monitor**
OUR PATH TO RECOVERY IN CRM BEGINS WITH UPCOMING LAUNCHES
16 *Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE
**Product not available for sale; remains in development
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SIGNIFICANT INVESTMENT IN FUTURE INNOVATION
Notable 2016 Investments:
Portico™ IDE trial: Over 1,200
randomized subjects*
Heartmate PHP™ Shield II trial: 425
patients*
Initiate Amplatzer Amulet IDE study
Initiate EnligHTN Renal Denervation IDE
study
Dual chamber leadless pacing
development work
Next-generation LVAD technology
Next-generation Confirm™ insertable
cardiac monitor**
Portico™ Transcatheter Aortic Valve
EnligHTN™ multi-electrode renal
denervation system
Nanostim™ leadless pacemaker
Confirm™ Insertable Cardiac Monitor
17 *Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
**Product not available for sale; remains in development
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INCREASING SHAREHOLDER VALUE
Intensify our FOCUS by surrounding disease states
Heart Failure, Atrial Fibrillation, Neuromodulation
Prioritizing programs and resources to surround care continuum
Continue to invest in INNOVATION to raise standards of care
Innovation leadership is our competitive advantage
Leverage CRM technology portfolio and expertise
Further develop ONE SJM CULTURE to mobilize employees
In support of our mission; driving productivity, commitment and teamwork
Strengthen EXECUTION and grow markets and sales
Product launches, market development and operating leverage
Deliver on EXPECTATIONS of our stakeholders
Doing what we say we are going to do
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THORATEC INTEGRATION:
A PRIORITY FOR 2016 Rachel Ellingson, V.P., Corporate Strategy
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Together as one company, we offer patients and physicians the most
comprehensive portfolio of products across the heart failure (HF) care
continuum
Expand the reach of left ventricular assist devices (LVADs) for advanced
stage HF
Integrate our technologies for improved therapy options
Leverage our global presence and enter new markets
Together we will lead the industry in heart failure management
BUILDING THE WORLD LEADER IN HEART FAILURE MANAGEMENT
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Full integration of Thoratec within the STJ global structure
The integration team is focused on:
Collaboration
Momentum
Organization
Culture
Speed
INTEGRATION GUIDING PRINCIPLES
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Maintain business momentum and leverage STJ’s expertise in HF, size and
distribution network as quickly as possible
Drive revenue growth through scale and by offering customers the broadest
portfolio of HF products
Deliver exceptional customer experience
Drive innovation leadership and doing so more efficiently through STJ
technology platform capabilities
Leverage cost and productivity synergies through integrated operations,
distribution and infrastructure
Implement “One St. Jude Medical” for organizational design and cultural
alignment
Identify and grow top talent across the business
INTEGRATION PRIORITIES
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Cultural alignment is a critical success factor in any merger or acquisition
St. Jude Medical and Thoratec have a shared commitment to:
Patients
Customers
Delivering innovation to save and improve lives
Our cultures have many areas of alignment – we expect to grow stronger
together by leveraging our differences
CULTURAL ALIGNMENT
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Revenue diversification and broader scale to our heart failure program
Business momentum continues with Q4 revenue beating expectations
Significant progress on cross-training sales and clinical resources
Revenue and cost synergies overachieving deal model
Provides incremental operating leverage and significant accretion in 2016 estimated
to be approximately $0.20 per share
Operational improvements
Manufacturing optimization and site consolidation
Joint cross-functional integration team in place and performing well
Functional integration plans have been developed
All employees reporting in “One St. Jude Medical” structure
PROGRESS
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Q1 2016 Executing functional
integration plans; key infrastructure
milestones
October 8
Acquisition completed;
Integration kick-off
First 60 Days
One STJ reporting; 2016 AOP
developed; Key site decisions made
Mid-2016 Fully functioning as
an integrated business
INTEGRATION CADENCE
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HEART FAILURE: MEDICAL
TECHNOLOGY LEADERSHIP Eric Fain, M.D., Group President
John O’Connell M.D., Medical Director, Mechanical
Circulatory Support and V.P., Medical Affairs
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HEART FAILURE – THE MARKET
71% 7%
2%
20%
CRT-D
CRT-P
CMEMS
LVAD
2016 Market Revenue >$4B
Market Growth*: Low to mid-single digits
* excludes the impact from currency
All dollar market sizes are based on estimated revenues
2016* Market Growth Expectations
WW: 2%-4%
U.S.: 3%-4%
Intl: 2%-3%
Market dynamics impacting the heart
failure market in 2016:
Destination therapy continues to be
primary growth driver WW for VADs
Establishing reimbursement for remote
hemodynamic monitoring
Continued shift in global markets to CRT,
increase in de novo mix, and premiums
for new technologies
~$300 million worldwide CRT-P
market growing in the high-single
digits
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HEART FAILURE BURDEN1,2
26M HF sufferers globally3
15M Europeans
5.1M Americans suffer from HF
>650,000 new HF diagnoses each year
1 in 2 HF patients die in 5 years
Burden on the U.S. healthcare system is high
2.8M office and emergency department visits each year
1.0M HF hospitalizations each year
Leading cause of hospitalizations among patients >65 years old
Class III and IV HF patients represent ~75% of hospitalizations4,5
Every 30 seconds, someone is hospitalized for HF
U.S. in particular focused on new approach to reduce hospitalizations
and improve outcomes
Heart Failure is a growing and expensive public health issue
of HF patients
die in 5 years1
50% 5.1M
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New York Heart Association (NYHA) Classification
II III IV
Intervention
or
Procedure
Percent of
Symptomatic
HF Population
48%
~12.5M patients†
39%
~10.1M patients†
13%
~3.4M patients†
Percent of HF
Admissions
20%
~200,000 admissions‡
44%
~440,000 admissions‡
32%
~320,000 admissions‡
Cardiac Resynchronization Therapy (CRT)
CardioMEMS™ HF
System
LVAD: Short and Long Term
HEART FAILURE THERAPY CHARACTERIZED BY THREE PRIMARY
DEVICE INTERVENTIONS1,2,3
†Based off 26M patients WW3 ‡Based on 1M U.S. admissions
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SUSTAINING LEADERSHIP IN CRT
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STJ QUADRIPOLAR INNOVATION SET THE NEW STANDARD OF CARE:
SUBSTANTIATED BY 100K+ IMPLANTS & 130+ PUBLICATIONS
Finding Citation
97% implant success rate6
40.8% risk reduction in LV lead related events7
19% improvement in responder rates at 12 months7
44% relative reduction in non-responders7
$2,197 patient cost savings at 180-days post implant8
18% reduction in mortality9 2014
2014
2014
2014
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Problem Statement
Non-responders remain a significant issue
even with advances in CRT technology
Cannot identify non-responders at implant
Solution: MPP provides an additional set of non-
invasive tools -- pacing from two locations on a single
lead to optimize and tailor CRT therapy
Tailor effective therapy
Improve outcomes for complex HF patients
Salvage non-responders or create super-responders
New Advanced Quadripolar Pacing Options**
Supplemental lead shapes for optimal placement*
Auto VectSelect Quartet™ Multivector Testing
MULTIPOINT™ PACING (MPP)*
THE NEXT GENERATION IN QUADRIPOLAR TECHNOLOGY
* Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE
** WW launch beginning in 1H 2016 32
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-4%
-2%
0%
2%
Q4'12 Q1'13 Q2'13 Q3'13 Q4'13
Growing body of evidence and real-
world experience continue to build
60 abstracts/publications to date
Experience in international markets an
analog for U.S. opportunity
Driver for share capture
Continued mix shift (now > 50% of CRT
with ASP premium in markets where
available)
Available in both CRT-D and CRT-P
Expect U.S. launch 2H 2016
MORE-CRT MPP Study:
Investigating conversion of non-
responders by MPP (~1,800 patients)
Expect to complete enrollment 1H 2016
MULTIPOINT PACING*: STJ INNOVATION FOLLOWING IN THE
FOOTSTEPS OF QUADRIPOLAR TECHNOLOGY
MDT quad
approval
STJ MPP approval
Finding Citation
Improved acute hemodynamic
response10-13
Increased Ejection Fraction14
Improved reverse remodeling15
19% improvement in responder rates at 12-
months16
44% relative reduction in non-responders16
Improved NYHA class17
Converted non-responders to responders17
STJ CRT-D Unit Share Shift: EMEA
33 * Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE
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ADVANCING HF STANDARD OF CARE
WITH CARDIOMEMS
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CURRENT BEST PRACTICE PROVEN TO BE INEFFECTIVE ACROSS
NEARLY 5,000 PATIENTS
Trial N Parameter Monitored/
Clinician Interaction
Impact on HF
Hospitalization Citation
TEN-HMS18 426 Signs/symptoms, daily weights,
BP, nurse telephone support None
TELE-HF19 1,653 Signs/symptoms, daily weights None
TIM-HF20 710 Signs/symptoms, daily weights None
INH21 715 Signs/symptoms, telemonitoring,
nurse coordinated DM None
BEAT-HF22 1,437
Pre-D/C HF education, regularly
scheduled telephone nurse
coaching & remote monitoring of
weight, BP, HR, signs/symptoms
None
Total 4,941
2010
2011
2005
2015
2012
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CARDIOMEMS IS DIFFERENT: IT ENABLES TREATING PATIENTS
BEFORE THEY EXHIBIT SYMPTOMS
Graph adapted from Adamson PB, et al. Curr Heart Fail Reports, 2009.
Only CardioMEMS HF System enables proactive management of patients
before visible symptoms, shown to reduce HF hospitalizations by 37%23
STJ proprietary
solution
PA
Pressure
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CARDIOMEMS HF SYSTEM EVIDENCE CONTINUES TO GROW
33 KEY PUBLICATIONS/ABSTRACTS AND COUNTING
37% Reduction in HF
hospitalizations at average
15-month follow-up20
48% Reduction in HF hospitalizations
when control group has access
to PA pressure monitoring21
Durability of treatment group
in absence of nurse
communications21 31
50% Reduction in heart failure
hospitalizations within HFpEF
population at average 18-
month follow-up22
Reduction in 30-day heart
failure readmissions in
Medicare population23 78%
53% Survivability improvement of
HFrEF treatment group
compared to guideline directed
medical therapy (GDMT) and
ICD/CRT therapy25
2010
2015
2015
2014
2014
2015 MO
NT
HS
37
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Heart failure with reduced ejection fraction (HFrEF; EF<40%)
~50% of total HF population (~13M WW)
Indicated for guideline determined medical therapy, ICD, and/or CRT therapies
Heart failure with preserved ejection fraction (HFpEF; EF>40%)
~50% of total HF population (~13M WW)
Underlying root causes not well understood,
no consensus GDMT
No solutions previously proven
prior to CardioMEMS
HF hospitalization rates equal to or
higher than HFrEF patients
CardioMEMS hemodynamic-guided HF therapy
is the 1st strategy to improve outcomes in HFpEF
Estimated at NNT = 2
HFpEF: ADDRESSING A LARGE UNDERSERVED HF POPULATION
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Clinical outcomes have been as good or better than observed in CHAMPION*
Training approach and integration into HF clinics has been validated in real world
Learning to proactively manage to pressure versus reactively responding to symptoms
or weight /blood pressure changes
New workflow
Manageable weekly review of trends
Replaces traditional non-reimbursable activities for clinicians such as regular and
patient-initiated phone calls, unscheduled clinic and ER visits and addressing symptomatic
patients
The reality of HF penalties29
Facilities with higher readmission rates now incur up to a 3% reduction in total Medicare
payments
Less than 25% of hospitals subject to the Hospital Readmissions Reduction Program
performed well enough on the CMS' 30-day readmission program to face no penalty
CARDIOMEMS IN THE “REAL WORLD”
39 *Interviews with doctors regarding specific results. Results may vary
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Reimbursement headwinds not atypical for new technologies
Favorable reimbursement at national level (NTAP and TAPTS)
Challenges at the local Medicare Access Carrier (MAC) level being addressed
and supported by new longer term data and publications
Novitas
Draft Local Coverage Determination (LCD) pending review of open comments
Expect decision 1Q 2016
First Coast Service Options (FCSO)
Reconsideration application for previous negative LCD submitted December 2015 and was
accepted January 2016
Expect decision 1Q 2016
IMPROVING REIMBURSEMENT TO ACHIEVE STANDARD OF CARE
40
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Pursuing CMS National Coverage Determination (NCD)
Initiated discussions with CMS in October 2015
Submitted NCD draft in December 2015
Submitted formal NCD application January 29, 2016
NCD applies nationally to all Medicare beneficiaries and supersedes any LCDs
Possible outcomes: Coverage, No coverage, Coverage with Evidence Development (CED)
CED provides coverage while additional data is collected to continue developing the evidence base
Common mechanism used by CMS to provide coverage for new technologies (e.g., TAVR, TMVR and LAA)
Expected Timeline/Process*
CMS NATIONAL COVERAGE DETERMINATION
NCD
Submitted
1/29/16
JAN
CMS
Decision
to Accept
Request
<FEB-MAR
End of
Public
Comment
Period
(30 days)
<OCT
Proposed
Decision
Released
(6 months from
acceptance)
End of
Public
Comment
Period
(30 days)
<SEP
Final Decision
Released
(within 60 days of
end of comment
period)
<DEC <MAR-APR
*Optional HTA or MEDCAC meeting adds ~3 months, but considered unlikely (not done for TAVR, TMVR or LAA)
2016 2017
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NEAR-TERM EVOLUTION OF CARDIOMEMS PLATFORM:
MERLIN.NETTM 9.0
Merlin.net Website myMerlinTM application EHR Integration
Patient receives medication
updates via smartphone app
Designed for both iPhone and
Android use
Bi-directional communication for
patient acknowledgement or
escalation
Further automates communication
with patient
Further eliminates/reduces phone
calls while documenting interventions
Technology-enabled prescription
adjustments
Medication updates electronically
pushed to patient’s smartphone
CardioMEMS notifications displayed
in EHR system directly
Allows CardioMEMS discrete data to
be selectively integrated into practice
EHR
Enables single site login within EHR
and Merlin.net to further streamline
workflow and leverage practice
system of record 42
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Our goal is to be the innovation and solution leader in HF
SUMMARY
Cardiac Resynchronization
Therapy (CRT) CardioMEMS HF System
Left Ventricular Assist
Devices (LVADs)
Product, Patient and Customer Synergies for Managing Heart Failure
CardioMEMS + CRT in Merlin.net
CardioMEMS-guided CRT programming & CardioMEMS-guided LVAD
Contracting across HF care pathway
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HEART FAILURE: MECHANICAL
CIRCULATORY SUPPORT John O’Connell M.D., Medical Director, Mechanical
Circulatory Support and V.P., Medical Affairs
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45
2,500
5,000
76% 93% 69% 66%
2014 2015 (est) 2013 2012
Notes:
(1) In the U.S. excludes HVAD stocking units prior to 2015.
(2) Excludes PVAD and market participants other than Thoratec and Heartware.
(3) U.S.- Q4’14 excludes a 53rd week for THOR
(4) OUS-Q4’14 excludes a 53rd week for THOR
HEARTMATE 3TM OFFERS NEAR-TERM OPPORTUNITY
FOR SHARE CAPTURE IN INTERNATIONAL MARKETS
5,000
2,500
0
2014 2015 (est) 2012 2013
42% 47% 47% 40%
HeartMate(HM)
HTWR
U.S. Market (Units) International Market (Units)
HM 3 offers opportunity for
share capture OUS
HM exited 4Q 2015 with ~73% share
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46
GROWTH DRIVEN BY TREMENDOUS BENEFITS OF THERAPY
0%
25%
50%
75%
100%
Baseline 6 Months
Bridge to Transplantation at 6 Months
0%
25%
50%
75%
100%
Baseline 2 Years
Destination Therapy at 2 Years
Improvement in NYHA Functional Class Over Time30
Could not
complete 345 m
average
Only 16% could complete
pre implant
94% could complete
post implant
Bridge-to-Transplantation Six-Minute Walk Test (6MWT)31,32
NYHA IV
NYHA III
NYHA II
NYHA I
Can’t Walk Can Walk
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HEARTMATE IITM IMPROVED ADVERSE EVENT RATES
Device RelatedInfection
Bleeding RequiringSurgery
Pump Replacement Isc Stroke Hem Stroke Hemolysis Thrombus
Trial PAS
0.06
0.031
0.47
0.22 0.07
0.052
0.024
0.06
0.024 0.027
0.23
0.09
0.057
0.026
Events/pt-year
Note: 3x scale difference for Device infection and Bleeding requiring surgery compared to others
Jorde, Khushwaha, Tatooles, et al. JACC 2014
Destination Therapy Trial vs. Post Approval Study (PAS)
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HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM IS
THE MOST WIDELY USED AND EXTENSIVELY STUDIED LVAD
Strong body of evidence
> 22,000 patients implanted
> 1,300 patient clinical trial (BTT & DT)
Extensive post-market study experience
with highly challenging patient populations
> 720 published, peer-reviewed articles
Reliability demonstrated by
> 2,000 patients at 3+ years of
support (longest >10 years)
Benefits continue to improve
over time
68% 73% 74%
Trial CAP PostApproval
68% 74%
85%
Trial CAP PostApproval
Bridge-to-
Transplant33
Destination
Therapy34
1-Year Survival Rates
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HEARTMATE 3 WITH FULL MAGLEVTM TECHNOLOGY FURTHER
STRENGTHENS COMPETITIVE POSITION
Design objectives
Reduced adverse events
Compact size for less invasive surgical
approaches
Return of pulsatility into continuous flow profile
Full support (flow) up to 10L/minute at lower
pump speeds
Large and consistent gaps allow for thorough
washing and avoidance of blood trauma (shear)
Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE. 49
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0.50
0.60
0.70
0.80
0.90
1.00
0 1 2 3 4 5 6
Perc
en
t S
urv
ival
Months
Estimated SHFM
HM3 actuarial survival
92%
78%
Estimated hazard ratio for the HM3 = 0.34
P = 0.0093
HeartMate 3 reduced the 6-month mortality risk by 66%
6-MONTH HEARTMATE 3* RESULTS IN IMPROVED SURVIVAL VS.
PREDICTED MEDICAL SURVIVAL USING SEATTLE HF MODEL
*Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE. 50
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HEARTMATE 3** HAS A FAVORABLE ADVERSE EVENT PROFILE
Days 0 – 30
(n=50)
Days 0 – 180
(n=50)
Event #
Pts
%
Pts
#
Events
#
Pts
%
Pts
#
Events
Bleeding 15 30% 19 19 38% 35
Requiring Surgery 6 12% 6 7 14% 8
GI 2 4% 2 4 8% 6
Any Infection 10 20% 14 18 36% 28
Sepsis 4 8% 4 8 16% 8
Driveline 1 2% 1 5 10% 5
Stroke 2 4% 2 6 12% 6
Ischemic 2 4% 2 4 8% 4
Hemorrhagic 0 0% 0 2 4% 2
Neurologic Dysfunction* 2 4% 2 4 8% 4
Right Heart Failure 4 8% 4 5 10% 5
Requiring RVAD 2 4% 2 2 4% 2
Pump Malfunction 0 0% 0 0 0% 0
Pump Thrombosis 0 0% 0 0 0% 0
Hemolysis 0 0% 0 0 0% 0
*TIA, seizures
**Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE. 51
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European limited market release 4Q 2015, full market release by the end of 1Q 2016
CE Mark approved mid-October 2015
30+ centers actively implanting by the end of 2015 (including major German centers)
200+ devices implanted through end of 2015
MOMENTUM 3 U.S. IDE Study (currently enrolling)
Over 1,000 patients at up to 60 U.S. sites (548 enrolled as of January 2016)
Single study design for short and long term use
First 294 patients with six month follow up (enrollment completed in October 2015)
Short-term indication FDA submission expected 2H 2016
First 366 patients with two year follow up (enrollment completed in November 2015)
Approximately 600 additional patients to evaluate Secondary Endpoints
Non-inferiority study randomized 1:1 against HeartMate IITM
Primary Endpoints: Survival on HeartMate 3 support free of stroke or pump replacement
HEARTMATE 3* PROGRAM IS ON-TRACK
*Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE. 52
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St. Jude Medical offers the broadest portfolio of mechanical circulatory support devices to treat the
full range of clinical needs for patients suffering from advanced HF
HeartMate II is the most widely used and extensively studied LVAD on the market
HeartMate 3 is a next generation LVAD with the first fully magnetically levitated compact VAD
MOMENTUM 3 IDE study continues to enroll
First quarter of the European launch was a success
Will complete the full rollout by the end of 1Q 2016
Short-term indication FDA submission 2H 2016
SUMMARY
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54
TITLE GUIDE TITLE GUIDE
SUBHEAD GUIDE SUBHEAD GUIDE
Q&A Panel Moderator:
Mike Rousseau, President and CEO
Panelists:
Phil Adamson, M.D., Medical Director and V.P., Medical Affairs
Eric Fain, M.D., Group President
John O’Connell, M.D., Medical Director, Mechanical Circulatory Support and V.P., Medical Affairs
Don Zurbay, Chief Financial Officer
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BULLET GUIDE BULLET GUIDE
HEADER GUIDE HEADER GUIDE
St. Jude Medical Important Dates in 2016:
First quarter 2016 earnings results conference call: April 20, 2016
Second quarter 2016 earnings results conference call: July 20, 2016
Third quarter 2016 earnings results conference call: October 19, 2016
MID-MORNING BREAK
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ATRIAL FIBRILLATION:
PLATFORM AND PIPELINE FOR
GLOBAL INNOVATION
LEADERSHIP Phil Ebeling, V.P. and Chief Technology Officer
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31%
16%14%
16%
11%8%
4%
EP AblationEP DiagnosticEP Mapping and Recording SystemsCardiac MonitorsAccessICE/OtherLAA Closure
ATRIAL FIBRILLATION (AF) – THE MARKET
2016 Market Revenue >$4B
Market Growth*: Low double digits
*excludes the impact from currency
All dollar market sizes are based on estimated revenues
2016* Market Growth Expectations
WW: 11%-12%
U.S.: 12%-14%
Intl: 9%-10%
Market dynamics impacting the AF market
in 2016:
~2.5% of the diagnosed symptomatic AF
patient population receiving ablation
Strong growth in ablation driven by catheter
ablation and advanced technology adoption
WW ablation procedures projected to reach
almost 950K in 2016 (double digit growth)
Force-sensing catheters quickly becoming
standard of care
Continued steady catheter ablation growth
expected for U.S. patients diagnosed with AF
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ELECTROPHYSIOLOGY (EP) ABLATION MARKET IS ~75%
IRRIGATED/ADVANCED ABLATION
Revenue in Millions
U.S. Catheter Ablation
Procedures estimated to be ~270K in 2016 (8% growth)
In two years over 50% of the U.S. irrigated ablation
catheter market moved to contact force
Market revenue growing at 17% (’13-’16 CAGR)
STJ expects to gain multiple share points in 2016
WW Catheter Ablation
Procedures estimated to be ~950K in 2016 (10% growth)
Market revenue growing at 11% (’13-’16 CAGR)
STJ expects to gain multiple share points in 2016
$0
$1,400
US WW
Estimated 2016 Catheter Ablation Market Size1
Standard Irrigated/Advanced
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INTEGRATED EP PRODUCT PORTFOLIO
WorkMate™ ClarisTM
Recording
System (1.1/1.1.1 software)
***MediGuideTM Technology
17.0 software,
**CRT 2.0 tools, Quadra Excel™
Guidewire, Sensor Enabled™
VantageViewTM System
HD display with add-on tools
***EnSite PrecisionTM
Cardiac Mapping System
TactiCathTM Quartz
Contact Force Ablation Catheter
**TactiCath™
Contact Force Ablation Catheter,
Sensor Enabled™
FlexAbilityTM
Ablation Catheter
*FlexAbility™
Ablation Catheter, Sensor Enabled™
AmpereTM
RF Ablation Generator
Cool PointTM
Irrigation Pump
AgilisTM NxT
Steerable Introducers
SwartzTM
Braided Transseptal Guiding
Introducers
BRKTM
Transseptal Needles
Access and Guidance
Advanced Ablation Recording Mapping
and Navigation Diagnostics and
Visualization
ViewFlexTM and ViewMateTM
Intracardiac Ultrasound
Reflexion™
Spiral Variable Radius Mapping
Catheters
LiveWireTM and InquiryTM
Steerable Catheters
ResponseTM and SupremeTM
EP Catheters
**Advisor™
FL Circular Mapping Catheter,
Sensor Enabled™
**Next Generation Confirm ™
STJ Integrated Lab
Complete Ablation Solution
*PMA under review
**Product not available for sale; remains in development
***510K pending
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FLEXABILITY AND TACTICATH ABLATION CATHETERS
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LOWER AF RECURRENCE AND SHORTER PROCEDURE TIMES USING
CONTACT FORCE1,4
LOWER AF RECURRENCE rate and SHORTER PROCEDURE
TIMES in contact force compared to conventional catheters
was shown in meta-analysis of 8 independent studies
involving 530 patients1
156
173
145
150
155
160
165
170
175
Procedure Times (min)
Contact Force Conventional
35%
46%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
AF Recurrence Rate
P=0.009
P=0.004
Using CF catheters was an INDEPENDENT
PREDICTOR OF PROCEDURAL SUCCESS
evaluating all patients undergoing RF ablation
for paroxysmal or persistent AF (n=721)4
Multivariate
Predictors of AF
Recurrence
HR 95% CI
Persistent AF 2.05 1.48-2.83
LA Volume >40ml/m2 1.42 1.04-1.93
CF Use 0.58 0.42-0.79
BMI 1.04 1.01-1.08
AF Duration (years) 1.07 1.04-1.09
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STJ is the only company to have defined optimal contact force parameters through a robust ,
compelling set of clinical studies
Using optimal contact force parameters with TactiCath catheter decreases rate of repeat ablation5
Using optimal contact force parameters with TactiCath catheter decreases patient cost of care one year
after ablation4
DEFINITION OF OPTIMAL CONTACT FORCE PARAMETERS KEY TO
IMPROVED OUTCOMES, LOWER COST
Optimal Contact Force Rate of Repeat Ablation5 Total Cost per Patient in Year After Ablation6
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TECHNOLOGY ADVANTAGES SUGGEST STJ SHARE
CAPTURE OPPORTUNITY
STJ’s proprietary sensor technology advantages:
Fiber optic sensing allows force to be measured closer to tip where power applied, allow uninhibited use of long
introducer sheath
50Hz sampling rate allows for visualization of transient peaks with cardiac movement and increased real-time
feedback
No calibration required, which may save time and shorten procedures
* Data from the TactiCath catheter are applicable to the TactiCath Quartz catheter as the design modifications made to the Tact iCath catheter were fully verifiable in
bench testing. The concept and working principle of the optical force sensor did not change
TactiCath™ catheter SmartTouch catheter
SmartTouch SF Lateral Contact Force measurements
showed error up to 41.7 g in lateral orientation7
A separate study characterized the contact force accuracy
of the TactiCath™ catheter. Results of this study showed
mean error was ≤ 1 g*8
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STJ ABLATION BUSINESS FUELED BY TACTICATH™ QUARTZ
>7% unit share gain in irrigated advanced ablation
in the U.S. since the launch of TactiCath Quartz9
Momentum continues to build with >350
TactiCath™ Quartz catheter accounts in the U.S.10
TactiCath represents over 50% of STJ’s U.S.
irrigated portfolio11
Expect approval of TactiCath in Japan 2H 2016
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FLEXABILITY™ ABLATION CATHETER RECEIVES PRAISE FOR
HANDLING, TIP PERFORMANCE
STJ irrigated portfolio growth outpaced estimated market growth in Japan by >10
percentage points in 201512
FlexAbility rapidly grew to represent 58% of STJ’s Japan irrigated portfolio within
the first year of launch13
Validated STJ’s next generation handle-shaft combination as the right platform of
the future
Next generation shaft: reliability, accuracy and consistent performance
Advanced handle-shaft combination: Maneuverability with comfort and ease of use
Distinct advantages of unique flexible tip
In recent preclinical work14, the FlexAbility™ ablation catheter showed comparable
lesion sizes to competitive catheters and had:
Significantly lower rate of steam pop when compared to ThermoCool™ SF
Less instances of char when compared to ThermoCool™
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STJ ABLATION SHARE CAPTURE IN 2015 JUST THE BEGINNING
Gained over 4 points of U.S. ablation catheter share
Increased STJ ablation catheter penetration with current NavX users globally
Anticipate continued FlexAbility, TactiCath adoption in approved geographies
Expect approval of TactiCath in Japan 2H 2016
FlexAbility ablation catheter TactiCath Quartz ablation
catheter Ampere RF
generator
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A REVOLUTION IN CARDIAC MAPPING:
AUTOMATED, FLEXIBLE AND PRECISE
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EnSite Precision Module, Sensor EnabledTM*
FlexAbility Ablation Catheter, Sensor
Enabled***
AdvisorTM FL Circular Mapping Catheter, Sensor EnabledTM**
EnSite Precision
Surface Electrode Kit*
EnSite AutoMap* AutoMark* EnSite Precision Software v2.0*
A comprehensive launch of tools and software throughout 2016
ENSITE™ PRECISION CARDIAC MAPPING SYSTEM
*510K pending.
**Product not available for sale; remains in development
***PMA pending review
Excludes China
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EnSite Precision* CARTO Rhythmia
Automated HD Mapping +
TurboMap feature
Flexible Workflow
Clinically validated Contact
Force parameters
Integrated Lab
Automated Lesion Marking
Proven Platform (Used in
100,000’s of procedures)
Fully Integrates Contact Force
Leverage Impedance AND
Magnetics coordinate systems
HOW DOES PRECISION STACK UP AGAINST THE CURRENT
GENERATION SYSTEMS
*510K pending. 69
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Designed for improved system and software ease of use
Anticipate improved data acquisition and speed of
acquisition in everyday use, for all procedure types
Faster decision-making with both positive and negative
morphology matching score15, 16
Faster, more accurate map creation with greater
consistency across cases15, 16
Secondary arrhythmias mapped up to 10x faster with
TurboMap feature
Enhanced VT mapping with automated morphology
matching capability15,16 and automatic catheter ectopy
rejection
NEW SOFTWARE PLATFORM* IS A GAME CHANGER
EnSite™ AutoMap Module, TurboMap Feature
*510K pending 70
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Only system to optimally integrate magnetic and
impedance data
3-D models with CT-scan-like detail – 27x†† higher
point density
Automated lesion marking guidance with the AutoMark
module17
Easily visualize scar tissue – integration
of delayed enhancement MRI imaging17,18
SparkleMap feature enables easy visualization of
voltage pathways on a single map
Customizable dashboard
Tailor patient therapy and streamline workflow
SYSTEM OPTIMIZED FOR TAILORED PATIENT THERAPY*
†† Based on minimum distance allowed between 3-D model points with Precision system versus
previous EnSiteTM VelocityTM system.
AutoMark Module
SparkleMap Feature
*510K pending
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INITIAL FEEDBACK VERY POSITIVE
Initial cases have been performed as part of a limited market release at 3
centers in Germany starting January 26
The EnSite Precision Cardiac Mapping system* was used in a variety of
procedures including atypical flutter, paroxysmal and persistent AF, and VT
System performance has been excellent through challenging procedure
dynamics such as: multiple patient defibrillations, fluid loading, lengthy
procedures times, and complex arrhythmia diagnosis and treatment
Limited market release is expected to continue in Italy and France in
coming weeks, followed by a full market release in 2Q 2016
Anticipate 510k clearance 1H 2016
“Improvements to model precision, model stability, and
mapping automaticity were significant and have delivered
the next generation of mapping technology to Leipzig.” - Prof. Gerhard Hindricks
EHRA President
EP Director, Heart Center, University of Leipzig
“Improvements to model precision and model stability were
significant. EnSite Precision addressed the concerns that
caused me to stop using EnSite Velocity about two years ago.” - Dr Christopher Piorkowski
EP Director, Heart Center, University of Dresden
“This system is exactly what I hoped it would be. AutoMap is
great. Very fast. Feels like the mapping data is more reliable” - Prof. Isabel Deisenhofer
Head Senior Physician, German Heart Center, Munich
Germany
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AMPLATZER AMULET: LEFT ATRIAL APPENDAGE
73
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BULLET GUIDE BULLET GUIDE We are a veteran in this space with a significant implant base and over
5 years of experience
STJ is the market leader in Europe
Ease of use
Broad size matrix
Complete seal of left atrial appendage
We plan to initiate global IDE Study in 2H 2016
Encouraging, on-going discussions with the FDA and CMS
Randomized clinical trial vs. approved BSX devices
LAA closure is an attractive, emerging opportunity. IDE study expected to begin in 2016
LEFT ATRIAL APPENDAGE (LAA) OCCLUSION
$-
$30
2011 2012 2013 2014 2015
STJ International LAA Revenue
Dollars in millions
*Constant Currency Compounded Annual Growth Rate
Product not available for sale in the U.S.; remains in development 74
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NEXT GENERATION CONFIRM: INSERTABLE
CARDIAC MONITOR
75
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Insertable Cardiac Monitor for Long-Term Arrhythmia Diagnosis
Drive share gains in >$600M market with low double digit growth
Small device size (<1.5cc)
Simple insertion procedure requiring minimal time and resources. Intuitive one-touch programming
Automatic wireless connectivity to Merlin.net
Simplified reports to facilitate monitoring and diagnosis
Expect CE Mark 2H 2016 and FDA clearance 1H 2017
NEXT GENERATION CONFIRM™
Incision and Insertion Tools
Next Generation Confirm Patient App (myMerlin) for iOS & Android
Remote Care (Merlin.net)
Product not available for sale; remains in development. 76
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BULLET GUIDE BULLET GUIDE Only company to offer full Integrated Lab – improving service offerings
Comprehensive training and on-site support
Contract/payment options with full purchase, complement of hardware and disposables
Offering our customers the broadest portfolio of solutions
END TO END EP/AF SOLUTION FROM STJ PROVIDES HOSPITALS,
PURCHASING TEAMS AND CONSUMERS AN ADVANTAGE
Lab Features: EnSite Precision™ cardiac mapping system; VantageView™ HD monitoring system;
ViewMate™ ultrasound console; MediGuide™ technology; WorkMate Claris™ recording system
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AF is one of the best growth stories in MedTech
WW market is expected to be over $4 billion and growing low double digits
STJ continues to have the deepest, broadest and most technologically advanced AF portfolio in the
industry
Demonstrated catheter technology leadership in 2015 with FlexAbility and TactiCath and expect to
continue to take additional ablation catheter share in 2016
STJ continues to see LAA occlusion as an attractive market and expects to begin an IDE study in
2016
Enter the insertable cardiac monitor market and the launch of the EnSite Precision Cardiac Mapping
System offer significant growth opportunities in 2016 and beyond
Market leading technology and most comprehensive EP portfolio
SUMMARY
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TRADITIONAL CRM: A PATH TO
RECOVERY IN THE U.S. Eric Fain, M.D., Group President
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WW TRADITIONAL CRM MARKET DYNAMICS
Market Dynamics
Low, single-digit unit growth offset by
pricing pressure
U.S. ASP pressure partially offset by shift
to CRT, increased de novo mix, and
premium for new technologies
OUS implants steady and positive
Japan bi-annual reimbursement cuts in
2016
49% 51%
Pacemakers (single & dual chamber)
ICDs (single & dual chamber)
2016* Market Growth
WW: flat
U.S.: -3% to -1%
Intl: 0% to 2%
2016 Market Revenue >$6.6B
Market Growth*: Flat
80 * excludes the impact from currency
All dollar market sizes are based on estimated revenues
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A PATH TO CRM SHARE RECAPTURE
Multiple new product launches in 2016 and 2017 that return our CRM business to
technology leadership
Expect to have new MRI labeled device submissions and launches across CRM
product segments in key markets globally
Once approved in the U.S., MultiPoint™ CRT Pacing and Nanostim™ leadless
pacemaker expected to provide competitive advantage in U.S. contracting
Continued growth and leadership in heart failure and AF improve the economics,
investment, and competitiveness of our CRM business
We are uniquely positioned to partner with hospitals by contracting across the
cardiovascular service line
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RETURN TO GLOBAL TECHNOLOGY LEADERSHIP IN CRM
The St. Jude Medical CRM portfolio demonstrates our leadership with innovative technology solutions
1 Launched in EU as part of post market clinical trial 2 IDE study completion in 2016 in United States
Smallest, longest
lasting wireless MRI
Pacemaker
New standard in CRT
pacing
Leadership in leadless technology
High Voltage MRI
portfolio Arrhythmia diagnosis
Assurity MRI™ Pacemaker* Nanostim™ Leadless
Pacemaker* MultiPoint™ Pacing*
MRI labeling for existing Ellipse™
& Fortify Assura™ ICDs, and
Quadra Assura™ CRT-D devices*
EU: Launched
U.S.: 1H’16
JPN: Launched
EU: Launched
U.S.: 2H’16
EU: Launched1
U.S.: 2H’16
EU: Launched
U.S.: 1H’172
JPN: Launching (ICD)
2H’16 (CRT-D)
Next Generation
Confirm™
Insertable Cardiac Monitor*
EU: 2H’16
U.S.: 1H’17
*Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
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1H 2016 U.S. launch of Assurity MRI™ pacer
World’s smallest, longest lasting wireless,
remotely managed, MRI pacemaker
Efficient workflow using the STJ MRI activator
1H 2016 Japan launch of MRI labelled ICD
Backwards compatible to existing device and
lead technology
Expect to see similar share recapture as LV MRI
launch
2H 2016 Japan launch of MRI labelled CRT-D
2016 MRI LAUNCHES WILL PROVIDE CATALYST FOR GROWTH
1H'12 2H'12 1H'13 2H'13 1H'14 2H'14
Pac
emak
er M
arke
t Sha
re
Impact of MRI Pacemaker Labeling
on STJ Share in Japan
Competitive
MRI PM launch
STJ MRI PM
launch
U.S. IDE clinical trial to support MRI labeling for existing HV devices
Enroll patients previously implanted with STJ HV devices
Endpoint based on 30-day follow-up of ~150 patients
Expect IDE completion in 2H 2016, launch in 1H 2017
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Clinical Summary
Over 1,000 Nanostim™ implants worldwide
Leadless II Study results presented at ESC’15 and in NEJM
Building back momentum in Europe with post-market registry
FDA Panel meeting scheduled for February 18, 2016
Expect U.S. launch 2H 2016
Product Characteristics
Smallest introducer size
Demonstrated chronic retrievability
Expect greater longevity than traditional VVI pacers
MRI labeling
Peri-operative complication rates similar to traditional VVI pacers with
absence of long-term adverse events observed
Dual chamber leadless pacing system development continues
to make progress
NANOSTIMTM LEADLESS PACEMAKER*
*Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
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SUMMARY
In 2016 our product cycle is a path to return STJ to technology leadership in CRM and
provide a foundation for sustained growth
Growth and share recapture in our CRM business will be driven by key product
introductions in 2016 including:
Assurity MRI (U.S.)
HV MRI (Japan and U.S. IDE)
MultiPoint Pacing (U.S.)
Nanostim (U.S.)
Next Generation Confirm™ Insertable Cardiac Monitor (OUS)
As momentum continues to grow in our AF and HF franchises, we expect to see increasing
benefit to our traditional CRM franchise as we partner and align with our customers to
address their greatest unmet needs
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NEUROMODULATION: BUILDING
THE MOST COMPREHENSIVE
PORTFOLIO Keith Boettiger, Sr. V.P. & General Manager,
Chronic Pain & Movement Disorder Therapies
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NEUROMODULATION MARKET OVERVIEW
Key Market Dynamics
Market remains underpenetrated
Oral opioid use under scrutiny
(especially U.S.) creating favorable
market conditions for effective, non-drug
therapies
Replacement cycle driving new units
(expect double digit growth of
replacements in U.S.)
Stable ASPs despite new competition,
driven by premium price capture for new
technologies
Competition from new entrants driving
market growth as awareness is raised
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2016 Market Revenue >$2.4B
Market Growth*: Mid to high-single digits
67% 8%
2% 23%
Traditional Spinal Cord Stimulation (SCS)
Radio Frequency Ablation (RFA)
Dorsal Root Ganglion (DRG)
Deep Brain Stimulation (DBS)
2016* Market Growth Expectations
WW: 7%-9%
U.S.: 6%-8%
Intl: 8%-10%
* excludes the impact from currency
All dollar market sizes are based on estimated revenues
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TREATING THE CHRONIC PAIN PATIENT
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PATIENTS ENDURE LONG, COMPLICATED PATH
Surgeon (General
Orthopedic) Referral
Diag-
nosis
Treat-
ment
Internal Medicine/GP Non-Interventional Pain
Management Interventional Pain
Management
Non-
Opioids
History
Physical Exam
Spine Surgeon Surgeon
Exercise
Psychologi-
cal Therapy
Physical
Therapy NSAIDS
OTC Meds
History History
Non-
Opioids
Injections Surgery
Exercise
Physical
Therapy
TENS NSAIDS
OTC Meds
NSAIDS
TENS Long Acting
Opioids
Opioids
OTC Meds
Physical
Therapy Exercise
Non-
Opioids
Non-
Opioids
SCS
Trial Pump
EMG
(PM&R)
NSAIDS
Physical
Therapy RFA
Injections
Non-
Opioids
Injections SCS
Implant
Exercise
2nd surgery
Physical
Therapy NSAIDS
OTC Meds
Non-
Opioids Exercise
Physical
Therapy NSAIDS
OTC Meds
3 – 5 Steps
6 mo. – 4 yrs. 2 – 8 Steps
6 mos.– 1 yr. 2 – 8 Steps
6 mos.– 2 yrs. 3 – 8 Steps
2 – 5 yrs 3 – 8 Steps
2– 6 yrs. 3 – 8 Steps
6 mos.– 4 yrs.
Path to treat pain is long and fragmented
Patients often desperate to resolve or reduce pain
Patients typically end at long-term opioid therapy at risk of addiction
Clinical and economic data demonstrate benefits of SCS earlier in the care continuum
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SPINAL CORD
STIMULATION
Burst gaining momentum where
approved*
SUNBURST RCT preliminary
results demonstrate superiority
vs. tonic
Invisible trial system: discreet,
convenient and Burst-enabled
trial experience**
iPod Touch and iPad Mini
leverage familiar iOS for
consumer friendly peripherals
RADIOFREQUENCY
ABLATION (RFA)
~$200M global market
~90% SCS implanters also use
RFA
Full line of RFA products including
generators, electrodes and
cannulae
Marketed in ~70 countries
DRG becoming standard of care for
Complex Regional Pain Syndrome
(CRPS) and peripheral nerve injury
internationally
ACCURATE trial demonstrates
superiority vs. conventional SCS
Estimated CRPS prevalence is 20%
of global market (DRG therapy
uniquely positioned to treat)
Groundswell of clinician excitement
for new technology to treat a poorly
treated patient group
DRG Launch: FDA approval
expected 1H 2016
DRG*
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STJ IS UNIQUELY POSITIONED TO SURROUND THE PAIN PATIENT
*Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
**In selected geographies where approved
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BURST THERAPY IS A PROPRIETARY ADVANCED
WAVEFORM PROVEN TO DELIVER SUPERIOR RESULTS
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In addition to SUNBURST randomized clinical trial, clinical evidence continues to grow:
German observational study shows STJ Burst equal to or better than HF-10 in head-to-head comparison
in 16 FBSS patients (>70% back pain with or without leg pain) randomized and blinded demonstrated 3
key findings1:
1. 100% trial conversion to Burst and 75% trial conversion to HF 10 (2 failures)
2. Both Burst and HF-10 achieved reduction in VAS for back pain that were not significantly different
3. Burst achieved significantly lower VAS for leg pain (p< 0.009)
Expect Burst U.S. approval and launch 2H 2016
WE ARE POISED TO TAKE SHARE WITH PROVEN STJ BURST
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Limited (~10%) market penetration with advanced
waveforms through 2015
STJ and one competitor with advanced waveforms
represent significant market share opportunity
Recent success in Australia demonstrates our
competitive position:
Australia market share leader*
Q1 2015 Pre-BURST: ~24%
Q4 2015 Post-BURST: ~31%
2014 2015 2016
New Waveforms (SCS)
Adv Waveform Penetration Adv Waveform Opportunity
4%
96% 91%
9%
85%
15%
*Based off of revenue, PWC Consortium data Q1 and Q4 2015
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Significantly improved pain outcomes
More than 90% of patients preferred Burst over tonic SCS with better pain relief cited as the primary
reason3-6
Almost 95% of tonic responders experienced a greater reduction in NRS score during Burst
stimulation7
Provided pain relief superior to tonic for overall, trunk, and limb pain6
Demonstrated ability to rescue prior failures
62.5% of non-responders responded to Burst8
Preferred by patients while preserving patient choice
69% of patients preferred Burst (p<0.001) 9
21% of patients still preferred Tonic stimulation and only STJ can provide both options in a single
solution9
Improved workflow
Burst required 50% fewer office visits and lasted 10% as long as regular visits10
GROWING EVIDENCE FOR BURST THERAPY
Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE
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Recharge-Free Platform Invisible Trial MRI
TREATING THE PAIN PATIENT; CREATING PATIENT PREFERENCE
Invisible therapy leading to
patient normalcy
Recharge-free; no patient
burden
First Bluetooth™ enabled
system
First Apple™ iPod touch™
and iPad mini™
programming system
Upgradeable technology
platform
First Bluetooth™-
enabled system
First “on body” trial
system
First Burst & Tonic
Capable EPG
Current state: Head and
extremity MRI
Future state: Full-Body
Conditional MRI
Expect U.S. launch of full-
body MRI in 2H 2016
Improve the patient experience with the Proclaim platform to create preference and
expand patient appetite for SCS trials through improved patient comfort and convenience
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STJ DELIVERING MORE FREEDOM
*Estimates based up daily recharging recommended in Nevro Patient Manual 11052 Rev A (2015-01-16)
Traditional Platforms
Step 1 – Identify IPG location suitable for recharging
Step 2 – Place IPG superficially to facilitate charging
Step 3 – Educate patient on charging
Step 4 – Daily or weekly charging for 1-4 hours (frequency dependent)
Proclaim™ Recharge Free Can be implanted almost ~2x deeper than rechargeable options
Designed to reduce patient burden and discomfort
Saves patient 1,825 hours, or 76 full days of recharging, over IPG options with
recommendations of daily charging in 5 years of use*
Gives patients an opportunity to focus on normal daily activities
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DORSAL ROOT GANGLION THERAPY IS A UNIQUE
SOLUTION FOR TARGETED PAIN SYNDROMES
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Total Knee Replacement
192
122
92
84
37
29 23
15
-10%
0%
10%
20%
30%
40%
50%
60%
-200 0 200 400 600 800 1,000
Ch
ron
ic p
ain
%
Procedures ('000s)
U.S. DRG Market Opportunities ($M)
DRG therapy is designed for focal pain conditions often characterized by nerve injury
Nerve injury is common in the large (and growing) postsurgical pain markets such as hernia, hip and knee
postsurgical pain syndromes
Several physician-initiated studies internationally hold promise to expand indications beyond current labeling
Etiologies are prevalent but poorly treated with current technologies providing a unique opportunity for DRG
therapy
Hernia Surgery
Amputations (lower extremity)
Cardiac Surgery
Mastectomy
Caesarean
Section Total Hip
Replacement Thoracotomy
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DRG STIMULATION EXPANDS THE MARKET
Notes where DRG is well-positioned
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DRG procedure similar to traditional SCS
>400K post-surgical intractable chronic pain patients (U.S. only)11-14
Uses low energy (<10% traditional) with minimal postural effects15
Compared to traditional SCS for patients with chronic lower limb pain
due to CRPS and peripheral causalgia, DRG stimulation provides15:
Sustained and superior pain relief
After 12 months, significantly more DRG stimulation patients achieved pain relief and treatment success
versus control SCS (74.2% vs. 53.0%)
Improved therapeutic targeting
DRG stimulation patients reported better stimulation targeting in their area of pain without extraneous
paresthesia (94.5% vs. 61.2%)
Improved quality of life (QoL) and reduced paresthesia
DRG patients experienced improved QoL measures, psychological disposition and activity levels
After 12 months, more than a third of DRG stimulation patients were experiencing greater than 80% pain
relief with no paresthesia
ACCURATE VALIDATES DRG AS SUPERIOR TO SCS
Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE
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Highly motivated and well-trained sales force
Excellent technical and clinical skills
Demonstrated ability to execute during technology reboot
Proven ability to build partnerships with interventional pain physicians and
sell product portfolio
Long-standing respect among physician community
FIELD SELLING ORGANIZATION PREPARED AND EAGER TO EXECUTE
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DBS OPPORTUNITY
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DEEP BRAIN STIMULATION (DBS) MARKET OPPORTUNITY
6.3M Worldwide
PREVALENCE (no differentiation for race or
culture)
DBS Penetration <1% of the addressable
population have been treated
with DBS <1%
$25B ECONOMIC
IMPACT $25B is the estimated annual
direct and indirect cost of
care for patients with
Parkinson’s disease in the
United States alone
SMALL NUMBER
OF IMPLANTERS ~150 is the number of
surgeons WW who perform
over 50 new cases per year,
~70% academic
150
2016: ~$600M worldwide market with high-single digit to low double-digit growth of
underpenetrated, monopoly market
Stable reimbursement
70% of cases done in less than 100 centers (U.S.)
50% of the market is IPG replacements
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WINNING WITH INNOVATION IN DBS
Patient Peripherals Infinity Platform Directional Lead
User-friendly Apple™
mobile digital devices
First Apple™ iPod
touch™ programming
system
Programming ease-of-
use for physician
App-based Bluetooth®
wireless communication
Competitive headers
First Apple™ iPad
mini™ programming
system
Upgradeable technology
platform
Steer therapy to avoid
stimulating undesirable
areas such as those that
produce side-effects
Reduce current for battery
longevity
Compatible extensible
extension
Platform engineered to fuel patient independence
DBS Global Launch expected 2H 2016 102
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STJ neuromodulation business transformed and positioned to be global technology leader
World-class field selling organization prepared and eager to execute
Only company with a portfolio that surrounds the interventional pain physician and treats chronic pain patients
throughout the continuum of care
Radio frequency ablation
Proprietary SCS Burst waveform with upgradeable capability
Dorsal Root Ganglion (DRG) therapy for targeted pain syndromes
Advanced waveforms show superior results to traditional therapy and only account for ~10% of the market
The ACCURATE study showed that DRG was superior in treating targeted pain syndromes versus tonic
Entering a DBS market that has been starved for innovation for the past 15 years
Directional lead technology as the future standard of care
Devices engineered for patient independence: Apple™ consumer devices and simplified programming
SUMMARY
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CARDIOVASCULAR: PRODUCTS
TO WATCH IN 2016 Phil Ebeling , V.P. and Chief Technology Officer
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CARDIOVASCULAR – THE MARKET
Market Dynamics
Strong double digit TAVR market growth
driven by expansion into lower risk patients
Tissue valves remain the gold standard for
most patients with aortic stenosis
WW market expected to continue to grow low-
single digits
Strong double digit growth in percutaneous
heart pumps
U.S. reimbursement established
PCI optimization market expected to grow
low double digits
Upcoming OCT reimbursement for U.S.
physicians
34%
24% 4%
13%
9%
6% 4% 6%
TAVR Surgical Valves PFO/CHD
PCI Optimization Closure Other
PHP Embolization
2016 Market Revenue >$6B
Market Growth*: High-single to low
double digits
* excludes the impact from currency
All dollar market sizes are based on estimated revenues
2016* Market Growth Expectations
WW: 9%-11%
U.S.: 12%-13%
Intl: 6%-8%
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BULLET GUIDE BULLET GUIDE Significant market opportunity
Strong double digit market growth driven by expansion into
lower risk patients
Consistent, positive physician feedback
Ease of use: prep, delivery, deploy and recapture, profile
Low rate of permanent pacemakers
IDE enrollment ongoing
Strong group of enthusiastic enrolling centers
Competitive trial recently completed enrollment
Exceeded Q4 2015 expectations
Key contracts awarded in Germany, Switzerland, Italy,
Nordics
First full quarter offering full portfolio of valve sizes
Full launch of a comprehensive PorticoTM transcatheter aortic valve size offering in international
markets, and a fully enrolling U.S. IDE provides meaningful growth in 2016
STJ IS AN EMERGING LEADER IN THE TRANSCATHETER AORTIC
VALVE MARKET
$0
$2
$4
2015 2016 2017 2018 2019 2020R
even
ue
(bill
ion
s)
TAVR WW Market (‘15-’20 CAGR: ~18%)
106 *Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE
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A self-expanding, repositionable and retrievable transcatheter
aortic valve**
PORTICO IDE TRIAL UPDATE*
Trial Design:
A prospective, multi-center, randomized-controlled study of TAVR in patients at high or
extreme risk for surgical AVR. 1,206 randomized subjects at 60 U.S. centers.
Portico Devices Studied:
23, 25, 27, 29 mm valves with transfemoral and transaortic/subclavian delivery systems
Control: Commercially available TAVR
Primary Endpoints:
Safety composite (mortality, stroke, bleed, AKI, Vasc Comp) at 30 days
Effectiveness composite (mortality, stroke, > moderate AI) at 1 year
Follow-up: 30 days, 6 months, 1, 2, 3, 4 and 5 years
** Repositionable and retrievable until fully deployed
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Scope:
Features to improve placement accuracy, ease of use, profile and trackability
Further improve paravalvular leak (PVL) performance
Expanded valve size offering (18mm – 30mm annulus size)
Transfemoral/subclavian/transaortic approaches
Product Overview:
Improved positioning accuracy with a stability layer
Improved valve placement with coaxial alignment during delivery
Reduced profile in combination with expandable sheath
Improved handle ease of use and ergonomics
Improved PVL performance with the addition of sealing feature
PORTICO NEXT GENERATION*
**Product not available for sale; remains in development 108
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Trifecta GT valve expected to launch globally in 2016 based off best-in-class hemodynamic
Trifecta platform
TRIFECTA WITH GLIDE TECHNOLOGY *
Tissue Valve Market
Remain the gold standard for most patients with aortic stenosis
WW market expected to continue to grow low-single digits
Trifecta GT
Next generation Trifecta valve
Improved ease of use while maintaining exceptional
hemodynamic performance
Improvement areas include: flexible sewing cuff,
streamlined holder, enhanced radiopacity
Initiate launch in key geographies in 1H'16
Trifecta GT
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PHP addresses a large, growing market and provides meaningful enhancements to competitive
offerings
HEARTMATE PERCUTANEOUS HEART PUMP (PHP)*
*Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
Significant future market opportunity
$300M+ in 2016, strong double-digit CAGR
~15% U.S. PCIs are High Risk
Adequate U.S. reimbursement in place
Disrupts traditional relationship between profile
and flow
Ease of use: prep, delivery, deploy and recapture, profile
Low profile, high flow with stability across the aortic valve
Consistent, positive physician engagement
SHIELD II IDE led by leading physicians
High engagement in study completion
15%
U.S. PCIs (~850k/year)
High Risk
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BULLET GUIDE BULLET GUIDE Trial Design:
Prospective, randomized, multi-center, open-label non-inferiority trial in the U.S. comparing HeartMate PHP to
Abiomed® Impella® 2.5 percutaneous cardiac support system
Trial Objective
Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary
artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high
risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG)
surgery
Scope
Up to 60 sites
425 patients randomized 2:1 (PHP: Impella® 2.5)
IDE Trial is evaluating the use of Heartmate PHP to support patients undergoing a high risk PCI
procedure
HEARTMATE PHP™ SHIELD II TRIAL*
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STJ continues to drive the PCI Optimization market through advancing the standard of care
with OCT and FFR
PERCUTANEOUS CORONARY INTERVENTION (PCI) OPTIMIZATION
PressureWire X* next generation FFR
pressure guidewire with excellent
steerability, wireless connectivity
and designed to be the most
reliable sensor technology
available
OPTIS Mobile brings the value of
Angiographic co-registration to the
OCT and FFR mobile cart system
Continued market opportunity
OCT/FFR market is projected to grow more than 12% (CN) in
2016 to ~$450 million WW
STJ is the leader in technology development
OPTIS Integrated, OPTIS Mobile with Angio Co-Registration,
PressureWire X*
Legacy of strong clinical data providing strong
clinical and economic outcomes
FFR: FAME I, FAME II, FAME III
OCT: ILUMIEN I, ILUMIEN II, ILUMIEN III
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BULLET GUIDE BULLET GUIDE At the October 2015 CPT Editorial Panel meeting, the AMA met and decided specific action relating to the use of OCT
As of Jan 1, 2017, the professional coding to describe use of OCT will fall under CPT codes 92978 and 92979, the same
codes as IVUS
The professional component (physician payment) will now be applicable to both OCT and IVUS (vs. IVUS only)
Clinical utility was supported by the publications on the utilization of OCT for PCI optimization, such as ILUMIEN I and
ILUMIEN II studies
Through STJ’s continued investment in clinical data and strong physician advocacy, improved
reimbursement will begin January 1, 2017
OCT REIMBURSEMENT PLANNED FOR U.S. PHYSICIANS
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Market opportunity: >100,000
patients/year with a cryptogenic stroke
and PFO in the U.S.
AMPLATZER™ PFO Occluder is superior
to medical management in reducing
recurrent cryptogenic ischemic stroke
Collaborating with FDA in preparation for
an FDA Panel Meeting 1H’16
Long-term data recently presented at TCT affirm the clinically meaningful benefit of Amplatzer PFO
closure to reduce the likelihood of recurrent cryptogenic stroke
AMPLATZER PATENT FORAMEN OVALE (PFO) CLOSURE*
*Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
1
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STJ remains committed to renal denervation therapy for hypertension and expects to
commence global IDE in 2016
HYPERTENSION – ENLIGHTN RENAL DENERVATION*
*Not available for sale in the U.S.
Significant future market opportunity
1.2B Worldwide prevalence
STJ preclinical efforts validate concept
Sustained blood pressure reductions in hypertensive swine
model
Provides confidence in treatment effect
STJ expects to begin global IDE in 2016
Sham-controlled, randomized controlled trial
On-going discussions with FDA
Global thought leader steering committee
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HEADER GUIDE HEADER GUIDE
Portico*: Competitive TAVR device provides a meaningful growth engine in 2016
First full quarter of all sizes in Europe exceeded expectations
Expect to continue to accelerate U.S. IDE enrollment
Trifecta GT**: Expected to launch globally in 2016 based off best-in-class
hemodynamic Trifecta platform
Heartmate PHP*: Provides meaningful enhancements to competitive offerings for
high-risk PCI patients
PCI Optimization: Through continued investment in clinical data and strong physician
advocacy, improved reimbursement will begin January 1, 2017
OPTIS Integrated, OPTIS Mobile with Angio Co-Registration, PressureWire X**
Amplatzer PFO Closure*: FDA panel meeting (1H’16)
EnligHTN Renal Denervation**: Committed to renal denervation therapy for
hypertension and expect to commence global IDE in 2016
SUMMARY
*Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
**Caution - NOT APPROVED IN THE UNITED STATES. NOT AVAILABLE IN ALL GEOGRAPHIES.
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TITLE GUIDE TITLE GUIDE
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Q&A Panel Moderator:
Mike Rousseau, President and CEO
Panelists:
Keith Boettiger, S.V.P. & General Manager, Chronic Pain and Movement Disorder Therapies
Allen Burton, M.D., Medical Director, Neuromodulation, Movement Disorders & Pain, and
V.P, Medical Affairs
Phil Ebeling, V.P., Chief Technology Officer
Eric Fain, M.D., Group President
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THANK YOU
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1. Go A, et al. Heart Disease and Stroke Statistics 2013 Update: A Report from the American Heart Association. Circulation. Published online
December 12, 2012.
2. Blecker, S, Paul, M et al. Heart failure-associated hospitalizations in the United States. JACC 2013 61:12 (1259-1267).
3. Lopez-Sendon, J. Heart failure today: A paradigm shift. Medicographia. 2011;33(4):363-9.
4. Costs to treat heart failure expected to more than double by 2030. http://newsroom.heart.org/news/costs-to-treat-heart-failure-expected-to-
more-than-double-by-2030. Accessed April 23, 2014.
5. Hunt SA, Abraham WT, Chin MH, et al. 2009 focus update incorporated into the ACC/AHA 2005 guidelines for the diagnosis and
management of heart failure in adults. Circulation. 2009;119(14):e391-479(e437).
6. Corbisiero R, Beau S, Allison S, et al. Intra-operative efficiency of the Quartet left ventricular lead. Presented during Cardiostim 2014, Nice
France. Session 56-65.
7. Boriani et al., Cardiac resynchronization therapy with a novel quadripolar lead decreases complications at six months: preliminary results of
the MORE-CRT trial, ESC 2014, FP# 887.
8. Graham CM, et al. Comparison of Healthcare Utilization and Hospital Costs for Quadripolar versus Bipolar LV Lead Technologies. HRS
2014. San Francisco, California. May 7-10, 2014.
9. Turakhia M et al. Reduced mortality with quadripolar versus bipolar left ventricular leads in cardiac resynchronization therapy. HRS 2014.
PO01-51. Retrospective data analysis.
10. Thibault, B., Dubuc, M., Khairy, P., Guerra, P.G., Macle, L., Rivard, L., ... Farazi, T.G. (2013). Acute haemodynamic comparison of multisite
and biventricular pacing with a quadripolar left ventricular lead. Europace, 15(7), 984–91.
11. Pappone, C., Calovic Z., Vicedomini, G., Cuko, A., McSpadden, L. C., Ryu, K., . . . Santinelli, V. (2014). Multipoint left ventricular pacing
improves acute hemodynamic response assessed with pressure-volume loops in cardiac resynchronization therapy patients. Heart
Rhythm, 11(3), 394-401.
12. Endrj, M., Ballari, G. P., Goletto, C., Rossetti, G., & Vado, A. (2015). Characterization of ventricular activation pattern and acute
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13. Osca, J., Alonso, P., Cano, O., Andres, A., Melero, J., Sancho-Tello, M. J., & Olague, J. (2015). Multipoint pacing in left ventricle with a
quadripolar lead improves cardiac dyssynchrony and haemodynamics in comparison to conventional pacing. Heart Rhythm, 12(5). pO02-
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14. Forleo, G.B., Santini, L., Potenza, D., Di Stolfo, G., Locatelli, A., Baracca, E., ... Zanon, F. (2015). Impact of multi-point left ventricular
pacing on QRS duration and left ventricular ejection fraction: preliminary results from a multicenter prospective study. Heart Rhythm, 12(5).
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15. Park, S.J., Chun, K., Park, K., On, Y.K., Kim, J.S. (2015). More favorable electrical and mechanical reverse remodeling after cardiac
resynchronization therapy with quadripolar versus conventional bipolar lead. Heart Rhythm, 12(5). AB28-05.
16. Pappone, C., Calovic Z., Vicedomini G., Cuko, A., McSpadden, L. C., Ryu, K., . . . Santinelli, V. (2015). Improving cardiac
resynchronization therapy response with multipoint left ventricular pacing: Twelve-month follow-up study. Heart Rhythm. 12(6):1250-8.
17. Pappone, C., Calovic Z., Cuko, A., McSpadden, L. C., Ryu, K., . . . Santinelli, V. (2015). Multipoint left ventricular pacing provides additional
echocardiographic benefit to responders and non-responders to conventional cardiac resynchronization therapy. European Heart Journal
Supplements, 17(Suppl A), A12-A17."
18. Cleland, J.G,, Louis, A.A., Rigby, A.S., Janssens, U., Balk, A.H,, TENS-HMS Investigators. (2005) Noninvasive Home Telemonitoring for
Patients With Heart Failure at High Risk of Recurrent Admission and Death: The Trans-European Network-Home-Care Management
System (TEN-HMS) study. JACC, 45, 1654-1664.
19. Chaudhry, S. I., Mattera, J. A., Curtis, J. P., Spertus, J. A., Herrin, J., Lin, Z., . . . Krumholz, H. M. (2010). Telemonitoring in patients with
heart failure. The New England Journal of Medicine, 363, 2301-2309.
20. Koehler, F., Winkler, S., Schieber, M., Sechtem, U., Stangl, K., Böhm, M., . . . Telemedical Interventional Monitoring in Heart Failure
Investigators. (2011). Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart
failure: The Telemedical Interventional Monitoring in Heart Failure study. Circulation, 123, 1873-1880.
21. Angermann, C.E.,Stork,S., Gelbrich, G., Faller, H., Jahns, R., Frantz, S., …Ertl,G. (2012). Mode of Action and Effects of Standardized
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Failure (INH) Study. Circ Heart Failure 2012;5;25-35.
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Effectiveness After Transition – Heart Failure Study - Remote Patient Management After Discharge of Hospitalized Heart Failure Patients.
AHA 2015 LBCT.
23. Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner
S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart
failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66.
24. Adamson PB, Abraham WT, Bourge RC, Costanzo MR, Hasan A, Yadav C, Henderson J, Cowart P, Stevenson LW. Wireless Pulmonary
Artery Pressure Monitoring Guides Management to Reduce Decompensation in Heart Failure with Preserved Ejection Fraction. Circ Heart
Fail. 2014.
25. Adamson PB, Abraham WT, Bauman j, Yadav J. Impact of Wireless Pulmonary Artery Pressure Monitoring on Heart Failure
Hospitalizations and All-Cause 30-Day Readmission in Medicare-Eligible Patients with NYHA Class III Heart Failure: Results from the
CHAMPION Trial. AHA. Nov 2014 Circulation , 130, A16744.
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pressure management in heart failure patients with reduced ejection fraction significantly reduces heart failure hospitalizations and
mortality above and beyond background guideline-directed medical therapy. Abstract 902-04 presented at ACC 2015, San Diego,
California.
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artery pressure management in heart failure patients with cardiac resynchronization therapy or implantable cardioverter defibrillator devices
significantly reduces heart failure hospitalizations and mortality above and beyond background guide-directed medical therapy. Abstract
AB37-03 presented at HRS 2015, Boston.
28. Abraham, W.T, Stevenson, L.W., Bourge, R.C., Lindenfeld, J…CHAMPION Trial Study Group. Sustained Efficacy of Pulmonary Artery
Pressure to Guide Adjustment of Chronic Heart Failure Therapy: Complete Follow-Up Results from the CHAMPION Randomised Trial.
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1. Shurrab, M., et al. (2015, May). Impact of contact force technology on atrial fibrillation ablation: a meta-analysis. JAMA 2015; 4e002476
2. Optimal CF cohort defined as those patients where ≥ 90% lesions ≥10 g
3. Non-optimal CF cohort defined as those patients where < 90% lesions ≥10 g
4. Providencia, R., Khoueiry, Z., Bouzeman, A., et al. (2015, May). Contact-force sensing using the SmartTouch and TactiCath catheter: head-
to-headcomparison and benefit on catheter ablation of paroxysmal and persistent atrial fibrillation. Presented at HRS 2015, Boston.
5. Reddy VY, Dukkipati SR, Neuzil P, Natale A, Albenque JP, Kautzner J, Shah D, Michaud G, Wharton M, Harari D, Mahapatra S, Lambert
H, Mansour M. A randomized controlled trial of the safety and effectiveness of a contact force sensing irrigated catheter for ablation of
paroxysmal atrial fibrillation: results of the TOCCASTAR study. Circulation. 10 Aug 2015. DOI: 10.1161/CIRCULATIONAHA.114.014092.
6. Data presented by Moussa Mansour, MD at AF Symposium 2016, Orlando, FL USA
7. Bourier, F., Hessling, G., Ammar-Busch, S., Kottmaier, M., Buiatti, A., Grebmer, C., . . . Reents, T. (2015). Electromagnetic contact-force
sensing electrophysiological catheters: How accurate is the technology? J Cardiovasc Electrophysiol Journal of Cardiovascular
Electrophysiology.
8. Yokoyama, K., Nakagawa, H., Shah, D., Lambert, H., Leo, G., Aeby, N., . . . Jackman, W. (2008). Novel Contact Force Sensor
Incorporated in Irrigated Radiofrequency Ablation Catheter Predicts Lesion Size and Incidence of Steam Pop and Thrombus. Circulation:
Arrhythmia and Electrophysiology, 1(5), 354-362..
9. Q3 2014 to Q4 2015 unit share gain
10. Total of 413 TactiSys units in Q4 2015 in United States
11. Q4 2015 portfolio mix in the United States
12. STJ unit growth of 31% year over year vs. estimated market growth of 19%
13. FY 2015
14. Winterfield, J., Jensen, J., Gilbert, T., Marchlinski, F., Natale, A., Packer, D., . . . Wilber, D. (2015). Lesion Size and Safety Comparison
between the Novel Flex Tip on the FlexAbility Ablation Catheter and the Solid Tips on the ThermoCool and ThermoCool SF Ablation
Catheters. J Cardiovasc Electrophysiol
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mapping procedure. Poster abstract P849. Europace,17(Suppl 3), iii115.
16. Ptaszek, L., Moon, B., Mahapatra, S., & Mansour, M. (2015, Nov). Rapid high density automated electroanatomical mapping using
multiple catheter types. Poster presentation P097. APHRS Scientific Sessions, November 21, 2015, Melbourne
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18. St. Jude Medical. Data on File. Report 90202460.
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2. Stirman, T., Hargett, J., Fontenot, H., and Peichel, D. (2015). Evaluating the Invisible Spinal Cord Stimulation Trial System – Results
from the INSTINCTS Study. NANS 2015.
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6. Courtney P., et. al. Neuromodulation 2015; 18: 361–366.
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