Patients - St. Jude Medical

Transcription

St. Jude Medical 2011
Investor Conference
February 4, 2011
Welcome and Opening Remarks
Dan Starks, Chairman, President and CEO
Forward-Looking Statements
The presentations throughout this meeting contain 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, anticipated regulatory approvals and
future product launches, and projected revenues, margins, earnings,
market sizes 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
Quarterly Report on Form 10-Q for the fiscal quarter ended October 2,
2010. The Company does not intend to update these statements and
undertakes no duty to any person to provide any such update under any
circumstance.
3
Agenda
8:00 a.m.
Overview of St. Jude Medical’s 2011 growth program.
Dan Starks, Chairman, President and Chief Executive Officer
We are bringing major new growth drivers to our CRM business.
Eric Fain, President, Cardiac Rhythm Management Division
William Abraham, M.D., F.A.C.P., F.A.C.C., F.E.S.C.
Panel for Q&A
10:00 a.m.
Break
DBS and migraine will be significant new growth drivers for our neuromodulation business.
Chris Chavez, President, Neuromodulation Division
Our AF business will sustain its growth with a strong cycle of new products.
Jane Song, President, Atrial Fibrillation Division
Gerhard Hindricks, M.D., Ph.D.
Panel for Q&A
Noon
Break and lunch buffet
Our cardiovascular business has meaningful new growth drivers in the structural heart and vascular
markets.
Frank Callaghan, President, Cardiovascular Division
Gregory P. Fontana, M.D.
Panel for Q&A
2:15 p.m.
Meeting Ends
Overview of St. Jude Medical’s 2011
Growth Program
5
Our Starting Point Is Credibility
 We did what we said we would do in 2010.
6
We said we expected to deliver 7%-11% sales
growth.*
 We delivered 10% sales growth.
* See slides 6, 7, and 8-25 from STJ’s 2010 investor conference.
7
We said we made corrections to our U.S. CRM
business during the second half of 2009 and
had entered 2010 on track to at least hold or
gain U.S. CRM share.*
 We gained approximately 3 points of U.S. ICD
share and 1 point of U.S. pacemaker share.
* See slide 23 from STJ’s 2010 investor conference.
8
We said we were well positioned to hold or gain
share in all major markets.*
 CRM grew 10% and gained share.
 AF increased 13% and held or gained share.
 Neuromodulation grew 15% and gained share.
 CVD increased 8% and held or gained share.
9
We said we were on track to deliver 12% - 14%
growth in EPS for 2010.*
 We delivered 24% growth in adjusted EPS.
10
We said we had a strong balance sheet and
cash flow to repurchase stock or fund
disciplined acquisitions as appropriate.*
 We purchased LightLab Imaging and AGA Medical.
 We repurchased $300 million of stock in addition to
stock repurchases tied to our acquisition of AGA.
11
We said STJ’s 2010 growth program included
significant focus and investment to leverage
EPS growth longer term.*
 We have completed our new facilities in Costa Rica and
Malaysia and already are shipping product. Due to
volume, gross margin improvement in 2011 related to
these facilities will be modest but will provide continued
improvement in 2012 and beyond.
 Improvements to supply chain and productivity of
customer service functions are underway.
 We expect these initiatives to reduce total costs by over
$100 million annually in future years.
12
We said STJ’s 2010 growth program included
significant focus and investment to accelerate sales
growth long-term.*
 We entered 2011 with over 14 initiatives to accelerate
our long-term sales growth.
 Q-4 results confirm that we are making good progress
delivering on these initiatives. Sales growth
accelerated during the quarter in all four of our major
business franchises.
 I will focus the remainder of my time on a review of our
initiatives to accelerate sales growth.
13
Cardiac Rhythm Management Sales
14
We restored growth to our U.S. CRM business
during 2010.
15

U.S. ICD sales grew 15% in Q-4 and 14% for full year
2010.

We are on track to gain approximately 4 points of ICD
market share in the U.S. over the next 4 to 6 years due
to a tailwind created by replacement market dynamics.

We have a strong pipeline of new ICD products
scheduled to launch in the U.S. in 2011. As a leading
indicator, international ICD sales that included these
products were up 21% constant currency during Q-4.
We are bringing a major new growth driver to our
CRM business.
16

During 2010, we completed a transaction with CardioMEMS that
gives us an exclusive option to purchase the company after FDA
approval of key technology.

The CardioMEMS CHAMPION trial showed a 39% reduction in
heart failure hospitalizations during an average follow-up duration
of 15 months.

This technology can be combined with our CRT systems for heart
failure patients and become a new billion dollar growth opportunity
following global market release and full development of the market.

Scheduled for limited launch in Europe in 2011 and in the U.S. in
2012.
Neuromodulation Sales
17
During Q-4, we began to launch our Eon Mini line of
spinal cord stimulators in Japan.
18

The success of our Eon Mini product line in the U.S.
and in Europe gives us confidence we can gain a
significant share of the spinal cord stimulation market in
Japan.

We expect additional growth from expanding the spinal
cord stimulation markets in China, India, Brazil, and in
other underpenetrated countries.
We are entering the market for deep brain
stimulation (DBS) for patients suffering from
Parkinson’s disease.

Full commercial launch in Europe began during Q-4 for
our Brio rechargeable deep brain stimulator, our Athena
DBS clinical programmer, and a complete line of
proprietary leads and accessories.

We plan to publish favorable data from our U.S. pivotal
trial during the first half of 2011.

We are second to enter the market and expect to gain
meaningful share.
19
During 2011, we expect to receive CE mark and
enter the market for neuromodulation in patients
who suffer from certain forms of migraine.
20

We will be first to market.

Market development will take time, but we expect our
migraine business to become a significant new growth
driver long term.
We are continuing to advance our neuromodulation
program for patients suffering from treatment
resistant depression.
21

In the U.S. we have completed the first phase of our
pivotal trial and are negotiating with FDA regarding the
second phase.

In Europe, we are evaluating whether existing clinical
data is sufficient to support a CE mark application.
Atrial Fibrillation Sales
22
We continue to strengthen our AF growth franchise.
23

International sales of AF products increased
approximately 15% constant currency during Q-4 and
are a leading indicator for the growth we expect as we
launch international products in the U.S.

Our first MediGuide enabled cath lab is on line in
Europe. This technology has the potential to become a
“game changer.”

AF market growth is being supported by new ESC
guidelines (September 2010), new AHA/HRS guidelines
(December 2010), the CABANA trial (ongoing), and by
continuous improvement in technology.
Cardiovascular Sales
24
We are entering the $500 million market for
pericardial stented tissue valves.
25

We began full commercial launch of our Trifecta line of
pericardial stented tissue valves in Europe during Q-4.

We expect full commercial launch in the U.S. by the
middle of 2011.

Early clinical response is encouraging and consistent
with our expectation that our Trifecta line of stented
tissue valves can become a major new growth driver.
We are preparing to enter the transcatheter aortic
valve implant (TAVI) market via our internal
development program.
26

We expect to launch both our transfemoral and our
transapical TAVI systems in Europe by the first half of
2013.

These systems are next generation technologies which
are expected to be fully competitive at the time of
market release.
We are preparing to enter the percutaneous mitral
valve repair (PMVR) market via an internal
development program.
27

This market can be as large as the TAVI market.

We expect to launch our PMVR system in Europe by
the end of 2013 or early 2014.
We are leaders in the fast growing market for
fractional flow reserve (FFR) guided therapy for
stenting patients with multi-vessel disease.
28

Two year data from our FAME landmark clinical trial
confirms comparative effectiveness with both clinical
and economic metrics.

We are continuing to expand this market with our FAME
II trial, ongoing product improvements, and conventional
market development programs.

We expect FFR measurement to become standard of
care and a significant growth driver for STJ.
During 2010 we entered the $500 million market for
intravascular imaging with our acquisition of
LightLab Imaging.
29

We have launched the first and only optical coherence
tomography (OCT) product line on the market in
Europe, Japan and in the U.S.

We are integrating our FFR technology into our OCT
hardware platform and expect strong synergy between
both new growth drivers.

We can integrate IVUS and other technology into this
platform if appropriate.
We are leaders in the emerging market for left atrial
appendage (LAA) closure in patients suffering from
AF.
30

The National Institute for Clinical Excellence (NICE) in
the U.K. issued a guidance in 2010 supporting the
comparative effectiveness of LAA occlusion in patients
with AF.

Full commercial launch is underway in Europe with
encouraging clinical response.

This market will create synergy with our AF growth
platform and has the potential to become a new billion
dollar growth driver.
We are leaders in the emerging market for patent
foramen ovale (PFO) closure in patients who suffer
from cryptogenic stroke.
31

In Europe, we have full commercial release, significant
product advantage, and clear market leadership.

Our U.S. pivotal trial is underway with over 800 patients
enrolled in an event driven trial design.

Our RESPECT trial is different than NMT’s CLOSURE I
trial with respect to trial design, patient selection, and
reliability of device performance.
We have a leading position in the market for
repairing ASD’s, VSD’s, and other structural heart
defects with minimally invasive catheter technology.
32

This is another franchise we acquired through the AGA
transaction.

Our market share is over 80%.

We expect to generate significant new market growth
through STJ’s global reach in Brazil, China, India, and
other large potential markets that are dramatically
underpenetrated.
We are the leaders with next generation technology
to block or redirect flow through blood vessels with a
vascular plug instead of with surgical clips or
embolic coils.
33

This is the fastest growing portion of the portfolio we
acquired through the AGA transaction.

AVP I and AVP II are on the market in the U.S. We
expect to launch AVP IV by mid-2011 and combine
these products with our introducer and Angio-Seal
business to create critical mass in the interventional
radiology lab.
We are preparing to enter the hypertension market
with a proprietary system designed to ablate nerves
within the renal artery.
34

Significant IP is in process.

Device design and animal work have been completed.

We expect to enter the market in Europe before the end
of 2013.
We are preparing to enter the stent graft market for
patients who suffer from thoracic aortic aneurysms
(TAA), and ultimately, abdominal aortic aneurysms
(AAA).
35

We expect to enter the TAA market in Europe before
the end of 2013.

Our technology is based on braided nitinol technology
we acquired through our acquisition of AGA.
Summary of new growth drivers.
Impacting 2011 and beyond
1.
2.
3.
4.
5.
6.
CardioMEMS***
Eon-mini/new geographies**
DBS Parkinson’s**
Migraine***
MediGuide/new ablation systems***
Trifecta**
* Market potential exceeds $250 million.
** Market potential exceeds $500 million.
*** Market potential exceeds $1 billion.
36
7.
8.
9.
10.
11.
12.
FFR**
OCT**
LAA***
PFO stroke***
ASD/VSD*
Vascular plugs
Summary of new growth drivers.
Impacting 2013 and beyond
13. TAVI***
14. PMVR***
15. Renal denervation***
16. DBS depression***
17. TAA/AAA***
18. PFO migraine***
The total market potential for these 18 new growth drivers exceeds
$14 billion.
*** Market potential exceeds $1 billion.
37
Conclusions
38

We have a balanced portfolio of major new growth
drivers to support our goal of returning to sustained,
double-digit growth in sales.

We have clear visibility into ongoing EPS leverage.

We have a strong balance sheet and cash flow to
continue to repurchase stock and fund disciplined
acquisitions as appropriate.

STJ’s program for superior long-term growth is robust
and on track.
We are bringing major new growth drivers to
our CRM business
Eric S. Fain, M.D., President, Cardiac Rhythm Management Division
CRM Market Dynamics
 Approximately $12 billion market in 2011
 Expect overall constant currency WW market growth
to remain in the low single digits
 St. Jude Medical growth story is not dependent on
market growth
 Our CRMD growth plan is driven primarily through:
– Replacement tailwind (should produce 4 points of market
share gain over the next 4-6 years)
– Share capture
– New key growth drivers
41
2010: Another Year of Industry Best Product Flow
Technology and innovation leadership in all segments
ICD
CRT
Pacemakers
Leads
DF-4 Durata
Fortify ICD
Unify CRT-D
Accent / Anthem®
Automaticity
Unlock
Remote Care
Merlin.net® Patient
Care Network 4.6
QuickFlex® µ
Merlin® PSA
CPS Direct® SL II
42
Overview of CRMD Platforms
CRMD Growth Platforms
Core
Differentiation
Continued Share
Capture
43
ST
Monitoring
Multi
Electrode
CRT
MediGuide
Continued Share
Capture and Market
Growth
Hemodynamic
Management
of HF
Core
Differentiation
Core Differentiation
Focused on targeted opportunities to meet market needs and take share
MRI Compatibility
1H 2011 (Int’l)
2H 2011 (U.S. IDE)
 Focus on minimal scanning
restrictions
 Improved workflow with MRI
Activator
 Recent CMS decision limits
market impact in U.S.
44
Inappropriate Shock
Therapy Reduction
CorVue™
Congestion Monitoring
Mid-2011 (WW)
2H 2011 (U.S.)
 ShockGuard™ optimized
programming
(98.5% IAT free @ 1 yr)
 Multi-vector thoracic
impedance measurements
 Currently available on
Unify/Fortify devices in
international markets
Core
Differentiation
Core Differentiation
ShockGuard™ Optimized Programming1
 Enhanced Nominal Settings
SJM ACT Registry ShockGuard Analysis
 Based on retrospective analysis
of ACT registry patients
 Complements existing
Unify/Fortify ATP during charge
and TWOS filter enhancements
 Shock reduction compares
favorably to published
Protecta data
 98.5% inappropriate
shock free at 1 year follow-up
 Available via software update
for all Unify® and Fortify® family devices
upon approval
1Data
45
from abstract submission to HRS 2011
40.7%
Reduction
80.3%
Reduction
57.1%
Reduction
ST
Monitoring
ST Monitoring
 Success in our international markets:
 Fully launched in Europe and Japan
 Significant traditional HV mix
 Significant double digit % price premium
 Opportunity to develop the market and
differentiate innovative SJM technologies
 Strong interest from academic centers and
referring cardiologists
 Will begin a large-scale U.S. IDE clinical
trial (>5,000 patients, 200 centers) in 2011
to evaluate the clinical benefits of ST
Monitoring
 Accent ST to be launched in international
markets by mid-2011
 Several applications (ACS, HF, VT/VF)
under investigation for demonstrating direct
clinical benefits
46
Accent™ ST
Fortify™ ST
Multi
Electrode
CRT
Multi Electrode CRT
Promote Quadra/Quartet Lead:
Revolutionizing CRT Pacing
 First and only Quadripolar
CRT-D system
 Opportunity for rapid growth in the
segment with our lowest share position
 Minimize tradeoffs between most stable
lead position and best pacing site
 Reduce complications from high
thresholds and phrenic nerve stimulation
 Multiple electrodes allow more options
for optimal pacing site
 Studies have shown significant
outcomes benefits of basal over
apical LV pacing1
47
1Singh,
JP, HRS 2010 Late-Breaking Clinical Trials "Left Ventricular Lead Position and
Clinical Outcomes: Findings from MADIT-CRT"
Multi
Electrode
CRT
Multi Electrode CRT
Independent, prospective study (N=45) demonstrated the benefits
of the Quartet quadripolar LV lead over bipolar LV leads1:
Implant Efficiency:


Freedom from Revision or Reprogramming
Bipolar: 21.7% patients required lead
repositioning (including change to a different
lead model) to avoid PNS
Quadripolar: only 4.5% patients required lead
repositioning to avoid PNS
Post-Implant LV Lead Complications:


1
48
Bipolar: 8.7% patients had LV lead
complications requiring reoperation and
surgical revision; 1 additional patient was
pending resolution
Quadripolar: No patients required reoperation
Forleo, G.B. et al. Left ventricular pacing with a new quadripolar transvenous lead for CRT: early
results of a prospective comparison with conventional implant outcomes, Heart Rhythm 2011
Jan; 8(1):31-7. doi: 10.1016/j.hrthm.2010.09.076.
Multi
Electrode
CRT
Multi Electrode CRT
 Very successful European launch of our Promote Quadra
system:
 >90 new CRT accounts opened since launch
 CRT-D growth rate approximately 3 times
the overall market growth in Q3’10
 Double digit percentage ASP increase
 Positive lead handling feedback
 No significant training requirements
 U.S. Launch of Quadra expected in mid-2011
 Expect adoption to be even faster
 Launch with downsized Unify Quadra
 Exclusive market position for multiple years
 Creating a new standard of care for CRT
 Continued leadership beyond 2011 with next generation
MultiPoint Pacing
49
MediGuide
MediGuide
 Opportunity to establish a new standard
of practice for CRM implants
 Unique value propositions for CRT
implanters:
 Reduction of X-ray exposure
 Reduction of implant time in complex
cases
 Improved visualization of venous
anatomy for higher implant success
rate in target vessel
 Future expandability into other CRM
procedures
 Integral to our Arrhythmia Management
Strategy and the “EP lab of the future”
 Available: ~1H 2012 (WW)
50
MediGuide
MediGuide
 Substantial number of CRT implants still
have prolonged fluoroscopy exposure
times
 Unlike an ablation procedure, the
implanter stands next to the radiation
source during a CRT case
 6-7x exposure compared to femoral
position1
 Annual occupational limits may be
exceeded in as few as 50 CRT
procedures/year
 Even sub-threshold exposures result in
noticeable increase of the chance of lifetime cancer2
 Fluoroscopy exposure is a growing
concern among many implanters and
patients
 FDA initiative to reduce radiation exposure
from imaging equipment and define
benchmarks and accreditation standards
for healthcare facilities3
1 N.
51
Theocharopoulos et al, Br J Radiol 2004; 79:644
L. Venneri et al, Am Heart J 2009; 157: 118
3 FDA White Paper: :Initiative to reduce Unnecessary Radiation Exposure from Medical
2
Imaging, February 2010
Hemodynamic
Management
of HF
Hemodynamic Management
of Heart Failure
The Opportunity: Heart Failure Hospitalizations
 An Unmet Clinical Need
 In the U.S., 1.1M HF hospitalizations annually; readmission rate of 25% and 50% at
30 days and 6 months, respectively
 Patients with preserved EF (EF>35%) or “diastolic HF” represent ~45% of the Class
III HF patients and have limited/no current tools to help with their management 1
 Large Patient Population (~$4-5 Billion Market Opportunity)
 All Class III HF patients with a previous hospitalization
 Diastolic population (EF>35%)
 Systolic population (EF<35%, no QRS restrictions)
US / EU Heart Failure
Total Prevalence
13.3 Million 2
Annual US/EU Hospitalizations
Class III HF
445K
Hemodynamic Monitoring
Patient Potential
445K Annually in U.S./EU
53
1: Solomon et al, Circulation 2005; 112: 3738-3744
2: AHA Heart Disease & Stroke Statistics, 2010 Update
HF Hospitalizations: Huge Financial Burden
 U.S. annual Medicare costs of ~$37B for HF hospitalizations with ~$17.4B of
costs for readmissions within 30 days
 Beginning in October 2012 (2013 FY) CMS may begin imposing penalties on
hospitals with excessive HF hospitalizations based on data collected the
previous year with penalties applied to all inpatient Medicare payments
 Private payers are expected to follow
 Methods to address this issue are currently limited
Example: Penalty for a Hospital receiving $25M in Medicare Payments*
800,000
700,000
600,000
500,000
3%
$750,000
400,000
2%
$500,000
300,000
200,000
100,000
1%
$250,000
0
2013
54
2014
*Assumes hospital’s HF readmissions exceeded HF readmission penalty rate each year
2015
Available Solutions Have Not Demonstrated
Effectiveness
 Weight, BP and Symptoms – Recent large, landmark
telemonitoring studies (Tele-HF, TIM-HF) have
demonstrated no benefit in monitoring these parameters to
reduce HF hospitalizations
 BNP – (PRIMA Study) guided identification of patients at
risk for HF events, but showed no significant reduction in
HF-related admissions.
 Device-Based Impedance Diagnostics – May be useful for
identifying patients that may be at higher risk for a HF
hospitalization, but have not demonstrated a reduction in
HF-related hospitalizations (PARTNERS-HF Study)
55
Tele-HF: Chaudry et.al, NEJM, 2010
TIM-HF: Koehler et al, Eur J. Heart Failure, 2010
PRIMA: Eurlings et al, Am Coll Card, 2010
PARTNERS-HF: Whellan et al, J Am Coll Card, 2010
The Solution:
Direct Hemodynamic Monitoring for HF Management
CHAMPION Trial
 CardioMEMS Pulmonary Artery Pressure (PAP) management system 1
 39% reduction in HF hospitalization during follow-up of 15 months
 Improvements in PAPs, proportion of patients hospitalized, days alive out
of hospital, and QOL
Chronic hemodynamic monitoring allows early, reliable detection and
provides clinically actionable insight
Physiological Progression of ADHF
Pressure Changes Occur Before Other Indicators
Impedance
Changes
Pressure Changes
-30
56
Days Preceding Hospitalization
Adapted from Adamson PB Curr Heart Fail Reports 2009;6:287
1: St. Jude Medical has an exclusive option to acquire CardioMEMS
Weight Changes
And HF Symptoms
Hospitalization
0
The Solution:
CardioMEMS Pulmonary Artery Pressure (PAP) System
CardioMEMS
PAP Sensor
CardioMEMS PAP Data Flow: Parallel to CRM Device Data Flow
Patient takes
pressure
measurement
57
Pressure downloaded
to an at-home device
Data uploaded to
a HF Portal
Physician reviews
pressure measurements on
HF Portal
SJM Will Provide a Complete and Integrated Solution
for HF Patient Management
HF Physician/Cardiologist
 Manage HF Patients
 Refer for CRM Devices
 Implant PAP Sensor
 Utilize Web-based CRM
Device and PAP Data
Electrophysiologist
HF
ClassClass
III HFIIIPatient
Patient
Interventional Cardiologist
 Refer for CRM Devices
 Utilize Web-based CRM Device and PAP Data
58
 Implant and Manage CRM Devices
 Utilize Web-based CRM Device
and PAP Data
Merlin.net: Leveraging Synergies Between CRM and PAP
Physicians want a single integrated website
for patient data
→ Only SJM Merlin.net
Market Implications
 HF physicians/cardiologists will more
actively influence CRM device brand
choices
 SJM positioned for accelerated share
capture with technology leadership of
Quadpole and PAP
 SJM CRM devices are expected to ‘pull
through’ PAP devices
 PAP will ‘pull through’ SJM CRM devices
 ‘Branded referrals’ for SJM de novo
 ‘Branded referrals’ for competitor
replacements
 Increased management tools of PAP plus
CRT may increase device penetration
59
Reimbursement: Favorable to Hospitals and Physicians
 DRG Assignment
 Current assignment DRG 261 ~$9,000
 Anticipate reassignment to DRG 264 (October 2011) ~$14,000
 Potential for additional New Technology Add-On Payment
 Estimated Physician Implant Reimbursement ~$800
 Hospital-based remote monitoring reimbursement
 Technical + Professional Fee ~$2,300 per year
60
Hemodynamic
Management
of HF
CardioMEMS: A Platform Technology






DynamicRx for patient self-management
AAA product (FDA approved and commercially available)
CRT device optimization (e.g., AV/VV timing, cardiac output)
LVAD optimization
Pulmonary hypertension management
Uncontrolled/resistant hypertension management
DynamicRx
61
Hemodynamic
Management
of HF
Opportunity Summary





Large population and revenue opportunity
Unmet clinical need creating a large financial burden
No other proven solutions
Reimbursement established and favorable
Synergies only available with SJM provide unique
opportunity for share capture
 Exclusive opportunity for multiple years, particularly
in the U.S.
 Platform for near-term growth
62
CRMD Summary
 St. Jude Medical has established itself as
the innovation leader
 Unmatched strength and breadth across all product
segments positions SJM for continued share capture
 New large growth drivers being implemented for nearand long-term impact with particular advantages in CRT
and HF management
 We are well positioned for growth in 2011 and beyond
63
Managing Heart Failure Patients Using a Wireless
Implantable Hemodynamic Monitoring System
William T. Abraham, MD, FACP, FACC, FAHA, FESC
Professor of Medicine, Physiology, and Cell Biology
Chair of Excellence in Cardiovascular Medicine
Director, Division of Cardiovascular Medicine
The Ohio State University
Columbus, Ohio
*U.S. Data: 2009 American Heart Association Heart Disease and Stroke Statistical Update
Background
• Despite current therapies and disease management
approaches, the rate of heart failure hospitalization
remains unacceptably high
 > 1.1 million heart failure hospitalizations annually
 > 20% readmission rate at 1 month; 50% at 6 months
 > $18 billion in annual direct costs
• Current methods for monitoring heart failure patients
have not adequately addressed this issue
• A new approach is needed to lower the rate of
hospitalization in heart failure patients
The Pulmonary Artery Pressure Measurement System*
Catheter-based delivery system
MEMS-based pressure sensor
Home electronics
PA Measurement database
*CardioMEMS Inc., Atlanta, Georgia, USA
Pulmonary Artery Sensor Implantation
• RHC plus selective pulmonary
angiogram
• Right or left PA branch, basal
(lower) lobe, descending branch,
pre-bifurcation
• Vessel Lumen ID: 10 mm (715mm)
• The Sensor and nitinol loops allow
placement in the pulmonary artery
in a distal location without injury to
artery
• Clopidogrel/ASA combination 1
month post-implant or previous
warfarin therapy
Left PA
Lower Lobe
Swan
Balloon
Target
Implant
Site
Pulmonary Artery Sensor Implantation
Video currently playing in
the Conference Hall. We
apologize for any
inconvenience.
Primary Results of the CardioMEMS Heart Sensor Allows
Monitoring of Pressure to Improve Outcomes in NYHA
Class III Heart Failure Patients (CHAMPION) Trial
Objective/Hypothesis
• The objective of the study was to evaluate the safety
and efficacy of the HF Pressure Measurement System in
reducing heart failure (HF)-related hospitalizations in
NYHA class III HF patients
• Primary efficacy was measured by comparing the rate of
HF-related hospitalizations during the 6 months
following implant in the TREATMENT group (standard of
care HF management plus HF management based upon
hemodynamic information obtained from the HF
Pressure Management System) with that of the
CONTROL group (standard of care HF management)
Study Design
• Prospective, multi-center, randomized (1:1), controlled
single-blind clinical trial
 All patients received sensor implant
 Treatment group received traditional HF management guided
by hemodynamic information from the sensor
 Control group received traditional HF disease management
• 550 subjects enrolled at 64 sites in the U.S. between
October 2007 and September 2009
• All subjects were followed in their randomized singleblind study assignment until the last patient reached 6
months of follow-up
Hemodynamic Management
Treatment Group
• Hemodynamic monitoring pressure target values:
 Pulmonary artery systolic pressure 15 – 35 mmHg
 Pulmonary artery diastolic pressure 8 – 20 mmHg
 Pulmonary artery mean pressure 10 – 25 mmHg
• Target pressures were reached using neurohormonal,
diuretic, and/or vasodilator therapies
Major Eligibility Criteria
• NYHA Class III heart failure on optimal/stable drug and device
therapy
• Hospitalized for heart failure within the past 12 months
• No history of recurrent (> 1) PE or DVT
• No GFR <25 ml/min if non-responsive to diuretic therapy or on
chronic renal dialysis
• Not likely to undergo heart transplantation within 6 months
• No congenital heart disease or mechanical right heart valve(s)
• No coagulation disorders or hypersensitivity/allergy to aspirin,
and/or clopidogrel
Endpoints
• Primary Safety Endpoint (at 6 months)
 Freedom from device/system-related complications
 Freedom from HF sensor failure
• Primary Efficacy Endpoint (at 6 months)
 Rate of HF related hospitalizations
• Secondary Endpoints (at 6 months)
 Change in pulmonary artery pressures
 Proportion of subjects hospitalized for HF
 Days alive out of the hospital
 Quality of Life
• Ancillary Analysis
 Rate of HF hospitalization over entire period of follow-up
Patient Disposition
550 Pts
w/ CM Implants
All Pts Take Daily
Readings
26 (9.6%) Exited
<6 Months
15 (5.6%) Death
11 (4.0%) Other
Treatment
270 Pts
Management Based on
Hemodynamics + Traditional Info
Control
280 Pts
Management Based on
Traditional Info
Primary Endpoint: HF Hospitalizations at 6 Months
26 (9.3%) Exited
<6 Months
20 (7.1%) Death
6 (2.2%) Other
Additional Analysis: HF Hospitalizations at All Days (15 Mo. mean F/U)
Multiple Secondary Endpoints
Implant Characteristics
• Total procedure time:
 Mean:
54 minutes
• PA pressures at time of Implant:
 PA Systolic:
 PA Mean:
 PA Diastolic:
45 ± 15 mm Hg
29 ± 10 mm Hg
19 ± 8 mm Hg
Patient Characteristics
Treatment
(n = 270)
Control
(n = 280)
p-Value
61 ± 13
62 ± 13
0.59
Gender (% female)
28
27
0.77
Race (% Caucasian)
73
73
0.92
Ejection Fraction (% ≥ 40%)
23
20
0.53
CRT/CRT-D (%)
34
35
0.72
ICD (%)
33
35
0.59
Diuretic use (%)
92
92
0.99
ACE-I or ARB use (%)
76
79
0.36
Beta-blocker use (%)
90
91
0.66
Age (yrs), mean ± SD
CRT = cardiac resynchronization therapy; ICD = implantable cardioverter-defibrillator
ACE-I = angiotensin-converting enzyme inhibitor; ARB = angiotensin receptor blocker.
Primary Safety Results
Consented
Not Enrolled
(n=25)
Treatment
(n=270)
Control
(n=280)
All
Patients
p-Value
Primary Safety Endpoint:
Device/System Related
Complications at 6 Months
# (%)
2(8)
3 (1.1)
3 (1.1)
8 (1.4)
<0.0001
Primary Safety Endpoint:
Pressure Sensor Failures
at 6 Months
# (%)
0 (0)
0 (0)
0 (0)
0 (0)
< 0.0001
1p-value
2p-value
from exact test of binomial proportions compared to 80% for All Patients
from exact test of binomial proportions compared to 90% for All Patients
1
2
Primary Efficacy Results
Treatment
(n=270)
Control
(n=280)
Relative
Risk
Reduction
83 (0.31)
120 (0.44)
30%
<0.0001
8
153 (0.44)
253 (0.72)
39%
<0.0001
4
Primary Efficacy Endpoint:
HF Related Hospitalizations
Up To 6 Months
# (Rate)
Ancillary Analysis:
HF Related Hospitalizations
Over Entire Randomized Period
# (Annualized Rate)
[Mean F/U: 455±211 (1–931)]
1p-value
from negative binomial regression
NNT = Number Needed to Treat
1
p-Value
NNT
Cumulative HFR Hospitalizations Over Entire
Randomized Follow-Up Period
Cumulative Number of HFR Hospitalizations
260.0
Treatment
Control
240.0
220.0
p < 0.0001 based on
Negative Binomial Regression
200.0
180.0
160.0
140.0
120.0
100.0
80.0
60.0
40.0
20.0
6 Months
15 Months
0.0
0
No. at Risk
Treatment
Control
90
180
270
360
450
540
630
720
810
900
82
67
29
25
5
10
1
0
Days from Implant
270
280
262
267
244
252
210
215
169
179
131
138
108
105
Freedom from HFR Hospitalization or Death (%)
Freedom From First HFR Hospitalization or Death
100.0%
90.0%
80.0%
70.0%
60.0%
50.0%
40.0%
HR = 0.71 (0.55-0.92), p = 0.0086
30.0%
20.0%
10.0%
Treatment
Control
0.0%
0
No. at Risk
Treatment
Control
90
180
270
360
450
540
630
104
80
84
57
62
39
Days from Implant
270
280
226
223
202
186
169
146
130
113
No Adverse Impact on Non-HF Hospitalizations
Hemodynamic monitoring reduced heart failure related hospitalizations
without increasing non-heart failure hospitalizations
Treatment
Control
229
263
83
120
146
143
484
590
153
253
331
337
6 Months
All Cause Hospitalizations
- HFR
Non-HF Hospitalizations
All Days
All Cause Hospitalizations
- HFR
Non-HF Hospitalizations
Secondary Efficacy Results
Treatment
(n=270)
Control
(n=280)
p-Value
Change from Baseline in Mean
Pulmonary Artery Pressure at 6
Months Mean AUC
-156
33
0.008
Subjects Hospitalized for Heart
Failure at 6 Months
# (%)
54 (20)
80 (29)
0.022
Days Alive Outside Hospital at 6
Months
Mean
174.4
172.1
0.022
45
51
0.024
Minnesota Living with Heart Failure
Questionnaire at 6 Months
Mean
AUC PA Mean Change from Baseline
up to 6 Months
100
PA Mean Preasure AUC (mmHg-Days)
80
60
40
20
0
-20
-40
p = 0.0077
-60
-80
-100
-120
-140
-160
-180
-200
Treatment (-155.7 mmHg-Days)
Control (33.1 mmHg-Days)
-220
0
30
60
90
Days from Implant
120
150
180
Heart Failure Medication Changes at 6 months
baseline medications
medication changes up to 6 months
Patients
Patients
Medications
Treatment
(270)
Control
(280)
Treatment
(270)
Control
(280)
Treatment
(2493)
Control
(1076)
ARB
42 (15.6%)
59 (21.1%)
32 (11.9%)
25 (8.9%)
144
0.0003
Ace Inhibitors
170 (63.0%)
173 (61.8%)
98 (36.3%)
65 (23.2%)
68
0.0290
Aldosterone Antagonist
117 (43.3%)
115 (41.1%)
72 (26.7%)
51 (18.2%)
160
0.0027
Beta Blocker
243 (90.0%)
261 (93.2%)
122 (45.2%)
97 (34.6%)
498
<0.0001
Diuretic-Loop
250 (92.6%)
264 (94.3%)
213 (78.9%)
163 (58.2%)
87
<0.0001
Diuretic-Thiazide
48 (17.8%)
51 (18.2%)
94 (34.8%)
57 (20.4%)
51
0.0022
Hydralazine
36 (13.3%)
33 (11.8%)
55 (20.4%)
30 (10.7%)
53
<0.0001
Nitrate
66 (24.4%)
57 (20.4%)
103 (38.1%)
35 (12.5%)
1061
<0.0001
Total
267
280
253
225
2493
1076
9.2±7.5
(270)
7.0
3.8±4.5 (280)
(0.0, 35.0)
(0.0, 38.0)
5.4 incremental medication changes
HF Medication Changes
Mean±StdDev (N)
Median
(Min, Max)
N/A
N/A
N/A
N/A
3.0
P < 0.0001
Efficacy Analysis by Baseline Ejection Fraction
Treatment
(270)
All
Patients
(550)
Control
(280)
# Pts.
(n)
# Hosp.
(n)
Hosp. Rate
(events/
patient-yr)
EF < 40%
208
73
0.36
222
101
0.47
0.0074
EF ≥ 40%
62
10
0.16
57
19
0.33
<0.0001
# Pts.
(n)
# Hosp.
(n)
Hosp. Rate
(events/
patient-yr)
p-value
[1]
[1] P-value from the negative binomial regression (NBR) model.
• These results demonstrate that HF management based on PAP is effective in
reducing HFR hospitalizations in patients with either reduced or preserved LV
function
• This trial represents one of the first successful management strategies to reduce
hospitalization risks for heart failure patients with preserved ejection fraction
Putting It All Together
Pulmonary Artery Pressure
Medication Changes On Basis of Pulmonary Artery Pressure
P<0.0001
Pulmonary Artery Pressure Reduction
P=0.008
Heart Failure Related Hospitalization Reduction
P<0.0001
Quality of Life Improvement
P=0.024
P values for Treatment Vs Control Group
Conclusions
• Heart failure management using the CardioMEMS
pulmonary artery pressure monitoring system resulted in a
significant reduction in HF hospitalizations:
 30% reduction in HF hospitalizations at 6 months
 39% reduction in annualized HF hospitalization rates for the
entire randomized follow-up
 Improvements in PAPs, proportion of patients hospitalized, days
alive out of the hospital, and quality of life
• The CardioMEMS pulmonary artery pressure monitoring
system represents a significant improvement in HF
management for NYHA Class III HF patients
Next Steps (Post-Marketing)
Panel for Q&A
Break
DBS and migraine will be significant new growth
drivers for our neuromodulation business
Chris Chavez, President, Neuromodulation Division
Neuromodulation Offers Multi-Indication Potential
SJM Approved Indications
in US and/or EU
Ongoing SJM Research
95
History of Growth
$410–$435*
$380
$331
$254
$210
$179
$153
$121
$91
$57
$32
$16
$23
$27
$38
$19
1996
1997
1998
1999
2000
2001
(Millions)
96
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011*
* Guidance
Eon Mini™ IPG: A Powerful Source of Growth
Now surrounded by even more innovation!
97
Leading Pain Research and Outcomes
Percentage of Patients Reporting
100.0%
50% or Greater Pain Relief
90.0%
80.0%
70.0%
67.5%
72.6%
70.9%
60.0%
50.0%
40.0%
30.0%
20.0%
10.0%
0.0%
98
Back Pain Relief
Leg Pain Relief
Overall Pain Relief
Sustained Pain Relief at Two Years
Percentage of Patients Reporting
100.0%
50% or Greater Pain Relief
90.0%
80.0%
70.0%
67.5%
72.6%
70.9%
60.0%
50.0%
40.0%
30.0%
20.0%
10.0%
0.0%
99
Back Pain Relief
Leg Pain Relief
Overall Pain Relief
Sustained Patient Satisfaction and Quality of Life
100
Promising Portfolio of New Indications



* CE mark approved in EU.
All others are ongoing clinical research or investigational.
101
Migraine Prevalence and Market Potential
United States
European Union
All Migraine
All Migraine
>30M
>43.2M
Chronic
Migraine
~4M
Severe and
Chronic Migraine
~1.5M
Chronic
Migraine
~7.3M
Severe and
Chronic
Migraine
~2.2M
Population-based estimates calculated from WHO prevalence data and multiple published epidemiology studies.
102
Migraine Treatment Continuum
Specialty
care
sought
Initial
diagnosis
made
Avoidance
Non-specific
drugs
NSAIDs,
acetaminophen
Often leading
to narcotics,
butalbitals
103
Migrainespecific
acute
drugs
Triptans,
ergots
Drug
escalation/
disease
escalation
Prophylactic
drugs
β-Blockers,
Ca-Blockers,
antidepressants,
anticonvulsants
Procedures
Nerve blocks,
BoTox,
stimulator
Prepare for European Migraine Launch
MIGRAINE
 Enrollment and 12-month follow-up
complete
 15 sites, 157 patients




104
Data analysis continuing
Data publication plan in development
CE Mark expected 2H 2011
U.S. regulatory strategy evolving
Migraine Clinical Study Update
 To demonstrate the safety and efficacy
of peripheral nerve stimulation in the
treatment of the pain associated with
chronic migraine headaches
Screen Failures
for a 52-week duration
111
 Patient selection criteria
 >15 headaches/month
 Symptoms refractory to at least 2
acute and 2 prophylactic medications
 Actual patient population
 26 headaches/month
 Alternative therapies tried >5
105
Enrolled
268
Permanently
Implanted
157
Stim On
105
Stim Off
52
12 Weeks
153
52 Weeks
133
Patient Satisfaction—52 Weeks
Were you satisfied with the results of your procedure?
70%
69%
60%
50%
40%
30%
27%
4%
20%
10%
0%
Very Satisfied/
Satisfied
Very Unsatisfied/
Unsatisfied
N=151
106
Unable to
Determine
Deep Brain Stimulation
A New Growth Driver
107
Deep Brain Stimulation
 DBS involves the application of
small electrical pulses to areas of
the brain
 Requires implantation of precisely
localized multi-contact electrodes
into specific targets
 Exact location identified using
anatomical and physiological
targeting
 High-resolution stereotactic
imaging, computer-guided surgical
navigation, and physiological brain
mapping are used to target
108
Global Disease Pool Amenable to DBS
Market Estimated at $390 Million—15% Growth
An Estimated 16 Million Patients
Indications
Parkinson’s Disease
Essential Tremor
Chronic Pain
Depression
600,000
80,000
400,000
12,000,000
Epilepsy
800,000
OCD
200,000
Tourette’s Syndrome
200,000
Dystonia
Internal estimate
109
Potential Patients
8,000
110
Enable Growth With A Strong DBS Product Portfolio
111
Libra™ DBS System Has Impressive Features
Constant Current Control
 Automatically adjusts to changing impedance
High-Capacity Battery
 ~40% more capacity than ActivaPC*
Highly Efficient Leads and Extensions
 Requires less battery power
Low-Profile Extensions
 Thinner and smaller extensions
More Therapy Options
* Data on file.
CE mark approved for commercial distribution in EU. TGA approved for commercial
distribution in Australia
CAUTION: Investigational device limited by U.S. law to investigational use.
112
Brio™ Rechargeable System and Athena™
Programmer: Best-in-Class Pair
Brio system
 Smaller and lighter
 Easier to recharge and maintain




Less sensitive to antenna positioning
Faster recharge rate
Longer time between recharges
10-year claim
 Constant current technology
 Deeper implant depth
Athena programmer
 Easy to use interface
 Color touch screen
 Easy reporting
 Data history/export capability
113
CE mark approved for commercial distribution in EU.
TGA approved for commercial distribution in Australia
CAUTION: Investigational device limited by U.S. law to investigational use.
Parkinson’s Disease Market—Large and Underpenetrated
Global Prevalence
Population expected to double by 20301
4.1 Million1
400,000–800,000 eligible for surgical treatment2
10-20%
80,0003 implanted
1. Dorsey et al, Neurology, 2007
2. American Academy of Neurology Parkinson’s Disease Guidelines
3. Medtronic
114
DBS—Parkinson’s
 Meta-analysis of 471 patients from 38 studies/34 centers concluded bilateral
STN stimulation is effective in the treatment of PD1
 UPDRS motor scores improved with stimulation both on and off medication
 At 12 months, mean improvement in:





Tremor
Rigidity
Bradykinesia
Gait
Postural instability
81%
63%
52%
64%
69%
 Recent randomized controlled trial published in JAMA found DBS to be more
effective than medical management2
 DBS patients gained a mean of 4.6 hours per day of “on time” without
troubling dyskinesia
 Best medical therapy gained 0 hours per day
1. Hamani et al. Bilateral subthalamic nucleus stimulation for Parkinson's disease: a systematic review of the clinical literature. Neurosurgery. 2008 Feb;62 Suppl 2:863-74.
2. Weaver et al. Bilateral Deep Brain Stimulation vs Best Medical Therapy for Patients With Advanced Parkinson Disease. JAMA. 2009;301(1):63-73.
115
Prepare for US PMA Submission
PARKINSON’S
 136 patients, 15 sites
 Enrollment and 12-month
follow-up complete
 Data is strong—will present at
Movement Disorder Society
meeting in June 2011
 PMA preparation in progress
116
How Satisfied Are You?
100%
87.4% 89.6%
91.9%
91.9%
94.8%
95.5%
90%
80%
70%
60%
50%
6 Months
40%
One Year
30%
20%
10%
0%
117
Very Satisfied
or Satisfied
You would
undergo this
procedure again
You would
recommend this
DBS system to
someone else
Depression
 A leading cause of disability in
the world (lost years of
productive life)
 One of the most common
mental illnesses, affecting more
than 21 million Americans each
year
 10% to 30% of the depressed
population does not respond to
treatment. Estimate 12 million
patients worldwide are
candidates for DBS Therapy
 877,000 suicides per year
worldwide
Source: WHO, NIMH 2006, Cadieux
118
Depression Continuum of Care
Source: Journal of Affective Disorders 117 (2009) S26-S43 and S44-S53; Research report: Canadian Network for Mood and Anxiety Treatments (CANMAT) Clinical
guidelines for the management of major depressive disorder in adults. Sections III. Pharmacotherapy and IV. Neurostimulation therapies
119
After Failing Multiple Drugs, Remission Is Unlikely
Remission as a Percent of Population at Treatment Stage
Cumulative Remission Rate = 67%
40%
35%
36.80%
30%
30.60%
25%
20%
15%
13.70%
13.00%
10%
5%
0%
First
Drug
Remission defined as ≤ 5 on QIDS SR16
Source: StarD Study
120
Second
Drug
Third
Drug
Fourth
Drug
Depression Pilot Study Update
 21 patients have completed
1 year; longest implant has
been 4.5 years
− No unexpected AEs occurred
during the study
4/5/6 Months
38%
9%
− No significant declines in
neuropsychological tests
 6 abstracts and posters have
been presented to date
 1-year data submitted for
publication
12 Months
29%
9%
121
53%
responder
non-responder
partial repsonder
62%
responder
non-repsonder
partial responder
BROADEN™ Study
Brodmann Area 25 Deep Brain Neuromodulation Study
A prospective, multi-center,
randomized, placebo-controlled
study to demonstrate the safety
and efficacy of DBS in
Brodmann Area 25 as an
adjunctive treatment for single
or recurrent major depressive
disorder (MDD)
www.BroadenStudy.com
122
DEPRESSION
BROADEN Study
Phase 1 Active Sites
Phase 1 Implants
50
Phase 2 Sites
20
Phase 2 Target Implants
123
3
231
Our AF business will sustain its growth with a
strong cycle of new products
Jane J. Song, President, Atrial Fibrillation Division
Agenda
 Revenue Growth and Market Size Opportunity
 Key Product Launches
 Clinical Studies
126
AFD Revenue Growth
9% - 13%
$900
$800
'05 - '11 CAGR
= 20%-21%
$700
28%
$400
$300
$628
$546
26%
$500
$708
15%
33%
$600
$770
- $800*
13%
$410
$326
$254
$200
$100
$0
2005
2006
2007
2008
Int'l
127
2009
U.S.
2010
2011
*Guidance
2011 Worldwide Market Size
Market Growth: 11% - 13%
Conv Recording, $120 Surgical Ablation
Devices, $145
Introducers and
Accessories, $220
Advanced
Mapping, $430
ICE/Other, $175
EP Ablation
Catheters, $640
EP Diagnostic
Catheters, $490
Total Market Revenue = $2.2 billion
STJ AF Revenue = $770 - $800 million
STJ AF Share = 35% - 36%
128
Monetary values in millions (unless noted)
AFD Product Portfolio
Access and
Guidance
129
Diagnostics and
Visualization
Advanced
Mapping
Advanced
Ablation
Complementary
Technologies
Key Product Launches
2011 Key Product Launches
 Agilis ES™ Steerable Sheath with visualization electrodes
 Inquiry™ AFocus II™ Mapping Catheter
 Safire BLU™ and Therapy™ Cool Path™ Bi-directional Ablation Catheters (U.S.)
 Safire BLU™ Duo Ablation Catheter (U.S.)
 Therapy™ Cool Flex™ Ablation Catheter (EU)
 Contact Safire BLU™ Duo and Therapy™ Cool Path™ Duo Ablation Catheters
(EU)
 ViewMate™ Z Ultrasound ICE Systems
 VantageView™ System
 EnSite Velocity™ v.3.0 Software Module
 EnSite Courier™ v.2.0 Software Module
 EP WorkMate™ Recording System v.5.0
131
Agilis ES™ Steerable Sheath with
Visualization Electrodes
 Used with the EnSite Velocity™ System
 Shows sheath and ablation catheter in 3D
mapping without the use of fluoroscopy
 Estimated H1 ‘11 – EU/U.S.
Steerable Versus Non-Steerable Sheath Technology in AF Ablation: A Prospective Randomized Study.
Piorkowski C, Eitel C, Rolf S, Bode K, Sommer P, Gaspar T, Kircher S, Wetzel U, Parwani AS, Boldt LH,
Mende M, Bollmann A, Husser D, Dagres N, Esato M, Arya A, Haverkamp W, Hindricks G.
1 University of Leipzig, Heart Center, Leipzig, Germany
CONCLUSIONS: AF catheter ablation using a manually controlled steerable sheath for catheter
navigation resulted in a significantly higher clinical success rate, with comparable complication rates and
with a reduction in peri-procedural fluoroscopy time. Clinical Trial Registration-URL:
http://www.clinicaltrials.gov. Unique identifier: NCT00469638.
132
Uni/Bi-Directional Irrigated Ablation Catheters
Safire BLU Duo and Therapy
Cool Path Duo Ablation Catheters
 More efficient irrigated tip with
12 holes
 Results in lower tip temperature
Safire BLU and
 New technology, high performance
Therapy Cool Path
shaft for improved reach and
 Uniform cooling tip
maneuverability
 Bi-directional deflection
 High performance shaft for  Available – EU / Estimated H2 ‘11 – U.S.
improved reach and
maneuverability
 Estimated H1 ‘11 – U.S.
133
Advanced Ablation –
Therapy Cool Flex Catheter
(uni-directional)
 Flexible, fully irrigated tip
 Preferential irrigation for
lower temperatures
 Efficient at low flow rates
 Estimated H1 ‘11 – EU / H2 ‘11
– IDE U.S.
EnSite Contact™ Technology
 Electrical Coupling Index (ECI) gives
proximity of tissue to tip contact
 Continuous, effective even during RF
energy application
 Contact-enabled premium irrigated
ablation catheters (via EEPROM)
 Displays on EnSite Velocity
 Tip beacon, meter, wave form
 Estimated H1 ‘11 – EU / H2 ‘11 IDE –
U.S.
ECI indicates tip
“far” from tissue
134
ECI indicates tip
“close” to tissue
ECI indicates tip
“far” from tissue
ViewMate™ Z Ultrasound ICE Systems
 Fully contained ZONARE hardware system
 Real-time image guidance and
visualization of anatomical structure
 Improved image/fidelity isolation box
 Next-generation transducer with
better image clarity
 Improved catheter with new control
handle (Agilis-style)
135
VantageView™ System
 State-of-the-art, integrated
imaging solution
 56” monitor with up to
eight displays
 Consolidates and eases
visualization of multiple outputs
 Streamlines work flow
136
MediGuide Implementation
MediGuide Implementation
 MediGuide/Siemens small flat-panel Artis Zee





gMPS II System
NTA start (Leipzig)
Additional EU Centers NTA
U.S. Centers NTA
EU/U.S. LMR
Approved
H2 ‘10
~H1 ‘11
~H2 ‘11
~H1 ‘12
 MediGuide enabled catheters
 Decapolar mapping catheter
 Safire BLU Duo/CP Duo BiD
 Safire BLU
Approved
~H2 ‘11 – EU
~H1 ‘12 – U.S.
 MediGuide Velocity software
 Integration with Velocity v3.0
138
~H2 ‘11 – EU
Fully Integrated MediGuide, Velocity, EP WorkMate, and VantageView System
139
Clinical Studies
Clinical Research Studies
St. Jude Medical has made significant investments in clinical research
studies:
 Clinical Development:
 CABANA - Atrial fibrillation ablation as first line therapy
 EAST - Early stroke prevention trial
 AFEQT - Atrial fibrillation specific Quality of Life assessment
 IDE Studies:





FLAIR - Atrial flutter
IRASE AF - Atrial fibrillation (endocardial)
CONVERT AF - Atrial fibrillation (epicardial)
FLEXION - Atrial flutter
CONTACT - Tissue sensing
 Phase V Studies:
141




Cease VT - Ventrical tachycardia
Magic AF - Atrial fibrillation CFAE ablation
Star AF - Atrial fibrillation
Other physician initiated studies
AFEQT (Atrial Fibrillation Effect on Quality of Life)
The AFEQT questionnaire is a reliable and
responsive measure of quality of life. Specifically for
patients living with atrial fibrillation. It is the first
questionnaire to be developed and validated on
atrial fibrillation patients.
Key Features:
 Validated questionnaire, patient derived with expert
clinical input
 Easy to use format with 20 questions on a 7 point
Likert scale
 Evaluates HRQoL across three domains:
 Symptoms
 Daily activities: validated/responsive
 Treatment concerns
AFEQT
overall
AFEQT
overall
SF-36
MCS
Symp.
Check
list
AFS
S
GAD 7
0.6
0.5
0.7
0.8
0.5
Change in AFEQT Score
25
SF-36
PCS
20
15
10
No
symptom
Mild
Sympto
m
Moderate
Symptom
Severe
Sympto
m
0.6
0.5
0.7
0.8
5
0
Change
frombaseline
baselineatatMo
Mo3 3
Change from
Development and validation of the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire in Patients with Atrial Fibrillation.
John Spertus, Paul Dorian, Rosemary Bubien, Steve Lewis, Donna Godejohn, Matthew RReynolds, Dhanunjaya R. Lakkireddy, Alan P.
Wimmer, Anil Bhandari and Caroline Burk. Circ Arrhythm Electrophysiol . Published online December 15, 2010; DOI:
10.1161/CIRCEP.110.958033
IRrigated Ablation System Evaluation for AF (IRASE AF) IDE
 Purpose:
To establish safety and efficacy of Duo
Ablation System for the Paroxysmal AF
1:1 Randomization
 Design:
 Multicenter, prospective randomized trial,
non-inferior pivotal IDE
 Principal investigator: Andrea Natale, M.D.
 324 patients, 40 centers
 Randomized against Thermo Cool
ThermoCool
Safire BLU Duo
 Endpoint:
 PVI acute success
 Efficacy: Freedom from AF 3-12 months
 Safety: SAE composite
 Estimated completion of enrollment: H1 ‘12
143
6 hole Irrigated Tip
12 hole Irrigated Tip
CONcomitant eValuation of Epicor left atRial Therapy for AF
(CONVERT AF) IDE
 Purpose:
To establish safety and efficacy of Epicor LP Cardiac Ablation System for surgical
elimination of permanent AF during concomitant open-heart procedures
 Design:
 Multicenter, non-randomized, historical control
 Create an epicardial box lesion off pump
on a beating heart
 Principal investigators:
Mark Groh, M.D., Vibhu Kshettry, M.D.
 116 patients, 20 sites
 Estimated completion of enrollment: H1 ‘12
144
Physician Initiated Studies - Ongoing Studies/Publications
145
Interventional Electrophysiology:
Chances, challenges and visions
Gerhard Hindricks, MD
University of Leipzig
- Heart Center Dept. of Electrophysiology
Interventional Electrophysiology: chances, challenges and visions
Catheter ablation over Europe 2007 - 2011
300000
250000
200000
150000
100000
50000
0
2007
2008
2009
2010
2011
Prevalence of atrial fibrillation
(USA 1990-2050)
Miyasaka et al, Circulation 2006
Catheter ablation of cardiac arrhythmias at HZL
2000
1800
1600
SKM
1400
Amount
VT
1200
EAT
AVN
1000
AVRT
AF
800
A-Fla
600
AVNRT
400
200
0
1998
1999
2000
2001
2002
2003
2004
Year
2005
2006
2007
2008
2009
2010
Catheter ablation of cardiac arrhythmias at HZL
2000
1800
1600
SKM
1400
Amount
VT
1200
EAT
AVN
1000
AVRT
AF
800
A-Fla
600
AVNRT
400
200
0
1998
1999
2000
2001
2002
2003
2004
Year
2005
2006
2007
2008
2009
2010
Target arrhythmias for interventional electrophysiology
• atrial fibrillation
– 1-2% general population
– 25% of all strokes are due to AF
– often disabling symptoms
– difficult to treat with antiarrhythmic drugs
• ventricular tachycardia
– fastest growing patient segment
– ablation is curative for idiopathic VT
– life saving in incessant VT
– may reduce morbidity and mortality in post MI VT
Technical and technological needs I
• catheter manipulation technologies
– stabilize ablation catheter
– access to difficult mapping sites
– improved lesion induction
• tissue-to-electrode contact assessment
- facilitates lesion induction
- reduces procedure time
- improves lesion durability
- may reduce recurrence rates
- may reduce risks
Technical and technological needs II
• innovative ablation catheter electrodes
– facilitate lesion induction
– reduce procedure time
– improves lesion durability
• tools to reduce treatment risks
- esophageal temperature monitoring
• novel navigation technologies
- improve precise catheter navigation
- reduce fluoroscopy time
- may be widely applied in electrophysiology
beyond electrode catheter navigation
Catheter ablation of AF over Europe 2007 - 2011
80000
60000
40000
20000
0
2007
2008
2009
2010
2011
Industry data / projections
Prevalence of atrial fibrillation
(USA 1990-2050)
Miyasaka et al, Circulation 2006
Interventional Electrophysiology: catheter ablation of atrial fibrillation
AF catheter ablation: areas of development
Ablation strategies
- segmental PV isolation
- circumferential PV ablation
- defragmentation
- ...
- individually tailored lesion sets
Clinical experience
Technologies
- improve catheter stability
- measure catheter contact
- improve energy delivery
- improve in-vivo orientation
Scientific data
Reconstruction of PV anatomy
Video currently
playing in the
Conference Hall.
We apologize for any
inconvenience.
Image integration to guide catheter ablation
Video currently
playing in the
Conference Hall.
inconvenience.
Image integration to guide catheter ablation
Video currently
playing in the
Conference Hall.
inconvenience.
Relevance of stable catheter access
LAA
LUPV
MA
LAA
LUPV
MA
LLPV
RLPV
The “concept”
LLPV
RLPV
The “reality”
Interventional Electrophysiology: innovative catheter navigation technology
Mapping/Navigation with steerable sheath
RAO 30°
Video currently
playing in the
Conference Hall.
inconvenience.
LAO 60°
Steerable Sheath: Prospective randomized study
• August 2007 – October 2009; 2 centers in Germany, 10 operators
• 123 AF patients (79 paroxysmal, 44 persistent)
• 1:1 randomization to ablation with/without steerable sheath
• Procedural endpoint:
Paroxysmal AF: Circumferential PV isolation
Persistent AF: + Box lesion, + MA line
• Follow-up with serial 7-day-holter (post ablation, 3 months, 6 months)
• Primary endpoint:
Freedom from AF/MRT after 6 months (on Holter and clinically)
• Secondary endpoints:
Safety, Procedural data
Piorkowski et al, Circulation A+E 2011, in press
Steerable Sheath: Prospective randomized study
ablation with steerable sheath
% patients with freedom from arrhythmia
ablation with non-steerable sheath
Univariable Analysis
Multivariable Analysis
Variable
Hazard Ratio (CI)
Pvalue
Hazard Ratio (CI)
Pvalue
Gender
2.029 (0.943; 4.367)
0.070
---
--
AF history
1.004 (0.999; 1.008)
0.091
---
--
Type of AF
2.366 (1.096; 5.106)
0.028
---
--
Type of sheath
2.8 (1.296; 6.049)
0.009
2.837 (1.197; 6.723)
0.018
20
Complete PVI
0.320 (0.116; 0.877)
0.027
---
--
10
Early recurrence1
2.289 (1.029; 5.091)
0.042
---
--
p=0.004
p=0.007
90
80
70
60
50
40
30
0
after 3 months
after 6 months
Piorkowski et al, Circulation A+E 2011, in press
Interventional Electrophysiology: innovative contact sensing technology
Approaches to objectively measure “contact”
• mechanical contact technologies
– fiber optic pressure sensing system
– magnetic sensor technology
• electrical contact technology
– ECI – assessment of local tip-tissue impedances
Conceptual aspects of catheter contact
Force
Electrical
contact
Holmes et al., JCE 2010
Sensitivity, specificify and PPV of TST
Piorkowski et al., JCE 2009
Electrical contact assessment
Video currently
playing in the
Conference Hall.
inconvenience.
Interventional Electrophysiology: novel ablation electrode designs
Evolving catheter tip technologies for RF delivery
Cool Flex
• 4 mm, 7 Fr
goal:
• flexibletip-tissue
tip with variable
• improved
contact slits
• homogenous
cooling in contact
• 4 distal holes
• adjustment of flow towards tissue
What's next? Cool Flex
Cool Flex: more contact @ similar force
Contact area = .001675 in2
Contact area = .004281 in2
Cool Flex: Multicenter Evaluation
• 22 patients with AF
• RF settings:
40 W, 15 ml/h, 48°C
• RF ablation time:
19±5 min
(50% reduction)
• Procedure time:
105±42 min
(25% reduction)
• no charring, popping, tamponade
Videos currently playing in the Conference Hall.
We apologize for any inconvenience.
Interventional Electrophysiology: improving safety
AF catheter ablation – complications at Heart Center Leipzig
JCE 2009, in press
AF catheter ablation – complications at Heart Center Leipzig
JCE 2009, in press
 A catheter with three circular temperature
sensors was placed in the esophagus of
the sedated patient
 visualized on NavX and fluoroscopy
 Re-adjusting energy and/or irrigation flow
rate in case of intraesophageal
temperature rise above 40 ° C
 Post interventional gastroscopy to assess for alterations of the esophagus
Alteration of the esophageal mucosa
Case Examples
day 1
 Food cessation
 Intravenous proton pump inhibitors
 Intravenous antibiotics for 2 days
 4 days after the ablation procedure healing was observed in all pts.
day 4
Interventional Electrophysiology: catheter ablation of cardiac arrhythmias
AF catheter ablation: areas of development
Ablation strategies
- segmental PV isolation
- circumferential PV ablation
- defragmentation
- ...
- individually tailored lesion sets
Clinical experience
Technologies
- improve catheter stability
- measure catheter contact
- improve energy delivery
- improve in-vivo orientation
Scientific data
Non-fluoroscopic catheter navigation visualized in cine loops
Current technologies for catheter navigation
• fluoroscopy
• non-fluoroscopic systems
- magnetic sensing
- impedance -based
• echocardiography
- ICE
• fluoroscopy
- magnetic sensing
- impedance -based
- ICE
• 2D visualization
• 2/3D-visualization
• fluoroscopy
- magnetic sensing
- impedance -based
- ICE
• fluoroscopy
- magnetic sensing
- impedance -based
- ICE
Medical positioning system (gMPS)
• gMPS (medical positioning system) / Mediguide
• magnetic navigation system
- transmitter
- magnetic sensor(s)
- data processing unit
• data communication with
- Siemens AXIOM fluoroscopy
- NavX EP work station
3D electromagnetic field
integrated into the
fluoroscopy detector
miniaturized sensor
technology
1mm
0.27mm
integration with
3D cardiac mapping
system (NavX)
The location box defines
the space where sensors S
can be precisely located
R S
A reference sensor R
attached to the patients chest
fully compensates respiratory
movement and patient movement
gMPS catheter navigation: first in human experience
• animal studies for system validation
• 52 patients undergoing diagnostic
electrophysiological study or catheter ablation
- diagnostic (n= 5)
- AVNRT / AVRT (n= 3)
- typical flutter (n= 11)
- AF ablation (n= 33)
• magnetic sensors built in 6F decapolar electrode
catheter (Livewire SJM)
• Mediguide “stand alone” set-up
gGMPS: cine loop acquisition
Video currently playing in the Conference Hall.
gMPS: Catheter positioning
gMPS: Multiple catheter visualization
gMPS: Catheter position validation
gMPS: Catheter positioning catheter manipulation
gMPS: Rhythm and rate compensation
gMPS: Patient movement compensation
gMPS: Left atrial catheterization
gMPS: Left atrial applications
Interventional Electrophysiology: cardiac resynchronization therapy
CRT for the treatment of heart failure
• cardiac resynchronization therapy (CRT)
– reduces hospitalization
– morbidity
– mortality
– improves QoL
• CRT implantation
- is (at times) challenging
- needs significant amount of fluoroscopy
- requires precise lead placement
gMPS: CS / CRT applications
Panel for Q&A
Break for Lunch
Our cardiovascular business has meaningful
new growth drivers in the structural heart and
vascular markets
Frank Callaghan, President, Cardiovascular Division
Introduction
In the recent past, our ~$1B cardiovascular business has
been encumbered by the low-growth market segments it
has traditionally served
 Mechanical and porcine heart valves
 Vascular closure
Through internal R&D investment and strategic acquisitions,
we have assembled a pipeline of new growth drivers which
will provide years of double-digit growth in revenue and
operating profit
 Vascular
 Structural heart
202
Vascular
In the Vascular segment, our pipeline will leverage existing
call points in Interventional Cardiology and Interventional
Radiology to provide diagnostic tools and therapeutic devices
to improve outcomes and reduce the cost of healthcare




203
PCI Optimization
Vascular Plugs for Peripheral Embolization Procedures
Endovascular Repair of Aortic Aneurysm
Renal Denervation for Hypertension
PCI Optimization
The optimization of PCI procedures with intracoronary
imaging and lesion assessment tools is a high growth
opportunity in the coronary intervention market
 WW coronary interventions number ~ 3.5 million / year
and are growing annually at ~ 2% - 3%
 U.S. and EMEAC PCIs number ~ 2.5M / year
 In today’s healthcare and economic environment,
technologies that improve outcomes and/or reduce
cost will increasingly penetrate PCI procedures
204
PCI Optimization
Currently, these modalities are very underpenetrated
 IVUS (Intravascular Ultrasound):
~15%
 FFR (Fractional Flow Reserve):
~ 5%
 OCT (Optical Coherence Tomography): < 1%
Even at today’s low penetration rates, the current combined
market for IVUS, FFR and OCT is ~ $700M
We believe that the combined penetration of these
modalities will more than double over the next 5 years to
create a combined market of $1.4B - $2.0B
205
PCI Optimization
Estimated Market Opportunity
FFR
PCI Procedures 3.5M / year
IVUS/OCT
PCI Procedures 3.5M / year
35% penetration
35% penetration
Procedures
Market Size
1.2M / year
$900M
Procedures
Market Size
Combined Procedures
Combined Market Size
206
2.4M / year
$1.9B
1.2M / year
$1B
PCI Optimization
We are the leader in the fast-growing market of FFR-guided
therapy for stenting patients with multi-vessel disease
We expect FFR measurement to become a standard-of-care
and a significant growth driver for STJ
 FAME: improved outcomes and reduced healthcare costs
 ESC elevated FFR to Class 1, Level of Evidence A
 We will develop clinical evidence to support a Class 1
designation in the U.S.
 STJ’s FAME II trial could foster further growth
207
PCI Optimization
We are the leader in the emerging market of OCT imaging
for patients undergoing PCI
We expect OCT to become a leading diagnostic tool and a
significant growth driver for STJ
We have programs to develop clinical evidence, expand
training, increase penetration and support reimbursement
208
PCI Optimization
In 2011 we will launch the world’s first imaging platform
integrating OCT and FFR
 A comprehensive turnkey solution for assessing physiology
and for imaging anatomy during coronary interventions
 Expands our FFR system installed base
 ~H2 2011 launch
PW USB Receiver
AO USB Receiver
PressureWire
Aeris
209
AO Interface Unit
(AIU)
Cathlab recording
system
PCI Optimization
In 2011 we will complete our program providing for wireless
integration of PressureWire into the cath lab
 Increases the penetration of FFR-capable labs by leveraging the
cath lab recording systems already present within them
 Always there, always on, always ready
 Completes the co-development for all major cath lab vendors
(to include Siemens and Philips)
 ~H2 2011
Wireless
Receiver
PressureWire
Aeris
Transmitter
Aortic Pressure
Cath Lab Recording System
210
PCI Optimization
We will introduce new imaging platforms to serve as the
foundation for expanded functionality and improved
performance
C7XR+





211
Doubles the imaging speed and increases scan length
Reduced contrast agent usage
3D imaging suite for better lesion visualization of stenosis
Automated measurements of vessel and stent malapposition
~H1 2012
Vascular Plugs for Peripheral Embolization
An emerging therapy for various peripheral conditions entails
the transcatheter embolization of vascular devices to block or
redirect flow
 Conditions treated include arteriovenous malformations and tumors
 Surgical clips and embolic coils have been the standard of care
 Potential neurovascular applications as well
Synergistic with STJ’s other products and initiatives to
increase penetration in Interventional Radiology
212
Procedures
200K / year
EVAR endo leaks
Pulmonary arteriovenous malformations
Other peripheral embolization procedures
50% penetration
Procedures
Market Size
213
100K / year
$100M
Status
 AVP I, II, III and IV are CE Marked
 AVP I and II are FDA approved
 AVP IV: FDA approval expected in H1 2011
214
Aneurysms develop when vessel integrity or strength is
diminished. The current standard of care, surgery, is
associated with high mortality and morbidity
 75% mortality if rupture occurs
 3 - 5% operative mortality with elective surgery
 Transcatheter endovascular repair of thoracic aortic
aneurysm (TAA) and abdominal aortic aneurysm (AAA)
is an emerging transcatheter procedure employing
stented grafts to ‘seal-off’ the aneurysm until it clots or
heals
215
Newly diagnosed patients with AAA and TAA:
Procedures (surgical and EVAR) per year:
567K / year
167K
80% penetration
Procedures:
Market Size
216
134K / year
$1.5B
Current focus is on TAA
 EU feasibility trial H2 2011
 CE Mark expected H2 2012
AAA program to follow TAA
Can leverage technology as a peripheral vascular graft
217
Hypertension* (HTN) is a significant public health problem
with profound clinical and health economic consequences
 #1 risk factor for death worldwide
 Significantly increases the risk of cardiovascular
disease, myocardial infarction, cerebral vascular
disease and chronic kidney disease
 Each increase of 20 mmHg systolic or 10mmHg
diastolic blood pressure is linked to a two-fold increase
in cardiovascular mortality rate over a ten year period
 At age 50, life expectancy is decreased by ~ 5 years
*HTN is defined as systolic blood pressure (SBP) greater than 140mmHg
or a diastolic blood pressure (DBP) greater than 90mmHg.
Source: American Heart Association, Joint National Committee Report 7
218
HTN affects approximately 1 billion people worldwide and is
projected to increase to 1.5 billion people by 2025
 U.S. Statistics
 76.4M prevalence of HTN
 1 of every 3 U.S. adults
 Worldwide Statistics
 1.0B prevalence of HTN
 One-third of the developed world’s adult population
 Estimated $500B annual direct cost globally
Sources: American Heart Association, National Center for Health
Statistics, World Health Organization, International Society of
Hypertension, Joint National Committee Report 7
219
While HTN can be controlled
with drugs and lifestyle
changes in the majority of
patients, uncontrolled or
resistant hypertension is a
significant unmet clinical need
U.S. Hypertension Population
Treated and
uncontrolled
25%
Untreated
32%
Treated and
controlled
43%
Treated and Uncontrolled = Adults with HTN taking antihypertensive medication and unable to achieve BP goal.
Treated and Controlled = Adults with HTN taking antihypertensive medication and achieving BP goal.
Untreated = Adults with HTN not taking anti-hypertensive
medication.
Resistant HTN = the “failure to reach controlled BP w/ > 3
drug regimen at optimal dosage and that includes at least 1
diuretic”.
Source: National Center for Health Statistics and STJ estimates.
220
Prevalence: 1B patients
25% with uncontrolled HTN
5% penetration
Patients
Market Size
221
12.5M
$30B - $40B
The renal sympathetic nerves are known to contribute to
the pathogenesis of HTN
222
 Surgical denervation,
reported in journals as early
as 1936, demonstrated
significant BP reduction but
was associated with high
complication rates
 Early clinical studies utilizing
catheter-based renal
denervation have shown
significant decreases in BP
in resistant HTN patients
 The long-term safety of renal
denervation has been
demonstrated in kidney
transplant patients
Source: American College of Cardiology 2009 Abstract
Our program leverages STJ’s core capabilities in product
development of advanced catheters and generators
 Proprietary catheter
 Efficient and effective ablation capability
 Generator
 Graphical display of ablation parameters and user feedback
 Simple procedure
 Easy to perform
 Short procedure time
 Precise, consistent lesion placement
223
2010 Milestones Completed
 Acute animal studies
 Chronic animal studies
2011 Expected Milestones
 GLP animal studies
 FIM clinical studies
– H1
– H2
U.S. IDE Planned Submission
– 2012
European Estimated Approval
– 2013
224
Structural Heart
With the recent acquisition of AGA Medical, STJ becomes
the only company in the Structural Heart market with
products or programs in all major categories
 Surgical Valves
 Mechanical
 Tissue
 Annuloplasty
 Congenital Defects




225
Atrial Septal Defects
Ventricular Septal Defects
Patent Foramen Ovale
Patent Ductus Arteriosus
 Emerging Transcatheter
Technologies
 Percutaneous Mitral Valve Repair
 Left Atrial Appendage Closure
 Transcatheter Aortic Valve
Implantation
Structural Heart
Our pipeline will leverage established STJ call points and
our global sales channels




226
Interventional Cardiology
Interventional Radiology
Cardiac Surgery
Electrophysiology
Structural Heart
We will also leverage the product portfolio from our Atrial
Fibrillation business to surround Structural Heart with an
unmatched portfolio of supporting products and services
ACross Transeptal Access System
MediGuide Navigation Technology
Agilis NxT Steerable Introducer
ViewMate Intracardiac Echo
227
Percutaneous Mitral Valve Repair (PMVR)
Mitral regurgitation (MR) is the most common form of
valvular heart disease
Mitral valve prolapse is the most common cause of organic
MR
More than 50% of mitral repair cases performed today are
due to a degenerative process whereby the valve leaflets
and chordae stretch, causing the valve leaflets to prolapse
into the left atrium during ventricular contraction
It is a significant public health problem which leads to LA
and LV dilatation, atrial fibrillation, pulmonary congestion
and heart failure
228
Diagnosed Prevalence of Organic MR: 4.5M
Diagnosed Prevalence of Organic MR due to Classic MVP: 2.2M
5% penetration
Patients:
Market Size
229
110K / year
$2B
PMVR is an emerging transcatheter approach for treating
mitral leaflet prolapse using transcatheter systems on a
beating heart
 STJ’s approach is based on a time-tested surgical
method of mitral leaflet repair
 We are developing transapical and transcatheter
systems
230
In 2011, our PMVR program is focused on demonstrating
feasibility, ease-of-use and quality of valve repair
In H2 of 2011 we plan on completing a first-in-man series to
demonstrate proof-of-concept using a transapical approach
 Francis Wells, M.D. and Peter Schofield, M.D.
Papworth Hospital, Cambridge U.K.
The development of transcatheter delivery systems for
transfemoral and transeptal approaches is in progress
 Estimated CE Mark end 2013 / early 2014
231
Transcatheter Repair of Congenital Heart Defects
In the U.S. and Western Europe, transcatheter repair of
congenital heart defects has experienced rapid adoption
over the past 10 years
 Proven clinical outcomes




Minimally invasive (vs. surgery)
High procedural safety
High closure rates
Strong durability history
(some > 13 years)
 AGA is the market leader with >80% share
 Amplatzer portfolio addresses all common congenital defects
 Reimbursement obtained in major markets
232
While the U.S. and European markets are highly penetrated
and growing in the low single digits, significant growth exists
in other markets which are dramatically underpenetrated
 Brazil
 India
 China
STJ’s global reach will create growth opportunity previously
unavailable to AGA
Additional growth from the recapture of distributor margins
in certain geographies
233
Estimated Market Opportunity (Emerging Markets)
China, India, Brazil: 510K newborns with CHD per year
71% with VSD, PDA, ASD
20% penetration
Patients
Market Size
234
73K
$200M
Left Atrial Appendage Closure
Atrial fibrillation affects ~7.5 million people in the U.S. & EU,
and its prevalence is growing as the population ages
In AF patients, blood clots can form in
the LAA due to blood stasis
 When these clots embolize, stroke,
myocardial infarction or systemic
ischemic events can occur
 An estimated 15% of all strokes are
caused by AF
 Stroke is the leading cause of adult
disability in the U.S. and Europe and is
the number two cause of death
worldwide
235
A major goal in managing AF patients is to prevent clot
formation in the LAA so that strokes and other catastrophic
events are avoided
 The current standard-of-care employs warfarin and/or
antiplatelet therapy to prevent clots
 Unfortunately, warfarin is very difficult to manage and
is potentially dangerous




236
Must be frequently monitored and adjusted
Sensitive to food, drugs, alcohol and genetics
Not tolerated in ~40% of patients
In the remaining ~60% the therapeutic range is hard to
maintain
What about dabigatran?
 In the RE-LY study, dabigatran demonstrated some
advantages in AF patients compared to warfarin
 Does not require blood monitoring
 Reduced risk of stroke and systemic emboli (high dose)
 Reduced risk of major bleeding (low dose)
 However, significant limitations of dabigatran remain





237
Stroke and systemic embolization still occur
Major bleeding still occurs
Patient compliance is always a problem
Lifetime commitment to drugs
Cost (> $6.00/day) is ~20x that of warfarin
Diagnosed Prevalence: 7.5M patients with AF
78% with persistent or longstanding-persistent AF
52% high risk for stroke
5% penetration
Patients
Market Size
238
154K
~$1B
The Amplatzer Cardiac Plug (ACP) enables permanent LAA
occlusion through transcatheter approaches. Potential
advantages include:





239
Easy to deliver and deploy
Repositionable
Complete ostial covering
Rapid occlusion
A lifetime free from dangerous
anticoagulants
STJ has wide access to AF patients through existing sales
channels
 Electrophysiologists
 Interventional Cardiologists
Significant portfolio synergies with our AF program
Full commercial launch is underway in Europe – where we
are leaders – and with encouraging clinical responses
The U.K.’s National Institute for Clinical Excellence (NICE)
issued a guidance in 2010 supporting the comparative
effectiveness of LAA occlusion in patients with AF
240
Market, Clinical and Regulatory Status
 CE Marked December 2008
 U.S. IDE feasibility phase is nearing completion
 33/45 patients, randomized 2:1
 H1 2011 estimated end enrollment
 U.S. IDE pivotal phase to commence ~H2 2011
 ~1100 patients (estimated), randomized 2:1
 PMA approval estimated end of 2013
241
Patent Foramen Ovale Closure – Stroke
A causal relationship between PFO and cryptogenic stroke
has been long suspected but never definitively proven in a
randomized trial
 The passage of blood, unfiltered by the lungs, directly
into the arterial circulation may allow venous and right
heart clots to travel to the brain
In the CLOSURE I trial, NMT Medical failed to demonstrate a
benefit of PFO closure vs. standard-of-care
242
Why STJ’s RESPECT trial is different
 Amplatzer device – better procedural success rate,
better closure rate, less device thrombus, less AF
 RESPECT patient selection – TIAs excluded
 CLOSURE I was probably underpowered
Status
 CE Marked for stroke in 1998
 U.S. pivotal RESPECT trial is underway
 850/~1000 patients randomized 1:1 vs. OMT
 PMA approval estimated for end 2012 / early 2013
243
Incidence: 3.3M patients/year
87% ischemic
30% cryptogenic
45% with PFO eligible for closure
Patients (U.S./EMEAC)
Market Size
244
380K / year
$1.7B
Patent Foramen Ovale Closure – Migraine
A link between PFO and migraine has also been
suspected but never proven in a randomized trial
We believe that NMT Medical did not meet its study
endpoints in MIST due to trial design, device differences
and protocol issues
Why STJ’s PREMIUM trial is different
 Amplatzer device – better procedural success rate,
better closure rate, less device thrombus, less AF
 Improved enrollment rates due to more favorable
inclusion/exclusion criteria
 Different clinical endpoints
245
Status
 CE Mark trial (PRIMA) is underway
 95/144 patients randomized 1:1 vs. OMT
 CE Mark estimated 2013
 U.S. pivotal trial (PREMIUM) is underway
 140/230 patients randomized 1:1 vs. sham
 PMA estimated late 2013 / early 2014
246
Annual incidence 6.4M patients / year
Prevalence diagnosed patients 66M
41% with PFO
1% resistant to meds with 6+
episodes per month
Patients (U.S./EMEAC)
Market Size
247
270K
$1.2B
Pericardial Aortic Heart Valves
Trifecta will soon launch in the U.S. and enable STJ to
participate in the ~$500M pericardial aortic valve segment
 We began full European commercial launch in Q4
 Trifecta has been very successful in Europe, with doctors
excited about its implantability and hemodynamics
 We expect full commercial launch in the U.S. by the middle
of 2011, where Trifecta will enable us to enter new
accounts traditionally held by competitors
 Early European experience reinforces our belief that
Trifecta can become a major new growth driver in the U.S.
248
Transcatheter Aortic Valve Implantation (TAVI)
Our TAVI program will produce highly-differentiated
products for transapical and transfemoral delivery
Greg Fontana, M.D., a National PI for our TAVI program, will
provide an overview of our system’s differentiating features
Loading Funnel
Loading Base
249
Loading Tube
Diagnosed Prevalence (Severe Aortic Stenosis):
20% TAVI penetration
Patients
Market Size
250
76K
$1.7B
379K
Our TAVI program is on track to hit several key milestones
in 2011 and beyond
 Start first-in-man experience (~H1 2011)
 Initiate our CE Mark trial (~H2 2011)
 We expect to launch both our transfemoral and our
transapical TAVI systems in Europe in the first half of
2013
251
Summary of New Growth Drivers
Vascular
$ 1.9 B
$ 0.1 B
$ 1.5 B
$ 35.0 B
________
$ 38.5 B
Optical Coherence Tomography
Intravascular Ultrasound
Fractional Flow Reserve
Vascular Plugs for Peripheral Embolization Procedures
Total Estimated Market Opportunity
Structural Heart
$ 2.0 B
$ 0.2 B
$ 1.0 B
$ 1.7 B
$ 1.2 B
$ 0.5 B
$ 1.7 B
________
$ 8.3 B
252
Percutaneous Mitral Valve Repair
Patent Foramen Ovale Closure for Stroke
Patent Foramen Ovale Closure for Migraine
Pericardial Aortic Heart Valves
Transcatheter Aortic Valve Implantation
Total Estimated Market Opportunity
Transcatheter Aortic Valve Implantation :
Next Generation Technology
Gregory P. Fontana, M.D., F.A.C.S., F.A.C.C.
Professor and Vice Chairman
Department of Surgery
Cedars Sinai Heart Institute
Los Angeles, California
Anatomical Relationships
Aortic Valve Anatomy “Normal”
Who needs Aortic Valve Surgery?





Aortic Stenosis
Aortic Insufficiency/Regurgitation
Both AS/AI
Endocarditis (abscess, conduction abnormalities...)
Aortic Root Aneurysm (if repair not possible)
Aortic Stenosis: Causes
 Degenerative/Senile
 Rheumatic
 Congenital
 Bicuspid
 Unicuspid
Aortic Stenosis: Indications for AVR
 Symptoms
 SOB, Chest Pain, Syncope (near or true)
 Reduced Heart Function (less than 50% ejection fraction)
 Concomitant Procedures when aortic valve is diseased
 CABG, Mitral Valve, Aorta pathology
Symptomatic Aortic Stenosis is Bad
The Problem of Aortic Stenosis Is Serious &
Treatment Options and Timing Matter
Aortic stenosis is life-threatening & progresses rapidly
Survival
Percent
Onset
severe
symptoms
100
Latent
Period
(Increasing
Obstruction,
Myocardial
Overload)
80
60
40
“Survival after onset
of symptoms is 50%
at two years and
20% at five years.”1
Angina
Syncope
Failure
0
2
4
6
Avg. survival
Years
20
0
Sources:
40
50
60
70
80
Age
Years
“Surgical
intervention
[for severe AS]
should
be performed
promptly
once even … minor
symptoms occur.”2
1
S.J. Lester et al., “The Natural History and Rate of Progression of Aortic Stenosis,” Chest 1998
2
C.M. Otto, “Valve Disease: Timing of Aortic Valve Surgery,” Heart 2000
Chart:: Ross J Jr, Braunwald E. Aortic stenosis. Circulation. 1968;38 (Suppl 1):61-7.
Aortic Stenosis in Patients without Symptoms
Should they undergo valve replacement?
The benefits of early valve replacement in asymptomatic
patients with severe aortic stenosis
Thomas A. Orszulak, et al, J Thorac Cardiovasc Surg , 2008
Patients who had symptoms and patients who remained
asymptomatic and had AVR had a survival advantage when
compared with asymptomatic patients who had medical
management alone!
ACC/AHA Guidelines do not reflect these findings……but
likely will be revised with growth of evidence.
TAVI vs. Medical Therapy: Inoperable Patients
All Cause Mortality
Freedom from Death (%)
Standard Rx
TAVI
HR [95% CI] =
0.54 [0.38, 0.78]
P (log rank) < 0.0001
Months
Numbers at Risk
TAVI
Standard
Rx
179
138
122
67
26
179
121
83
41
12
ARTIFICIAL VALVE EVOLUTION
FEASIBILITY PHASE
PIONEERS’ WORK (1950’s)
Dr. C. Walton
Lillehei
Dr. Charles
Hufnagel
IN THE BEGINNING
1952 - First Mechanical Valve
Implanted by Dr. Hufnagel in the descending aorta
70% Reduction
in AR
FIRST HEART LUNG “MACHINES”
GIBBON 1953 HEART-LUNG MACHINE
LILLEHEI 1954 CROSS CIRCULATION
1ST REVOLUTION
MECHANICAL VALVES (1960’s)
MECHANICAL VALVE EXPLOSION: INNOVATION
BIOPROSTHETIC HEART VALVES
Homografts from human valves paved the way for
biological valves by eliminating the need for
anticoagulation treatment.
The limitation on the supply of homografts led to the
search for other biological source materials for
bioprostheses.
The high level of skill necessary for the implantation of a
free homograft led to the development of cloth-covered
stents.
Alain Carpentier, M.D.
PORCINE BIOPROSTHESES




1967 – Carpentier bioprosthesis (rigid stent)
1968 – Hancock I valve
1974 – Carpentier (flexible stent)
1992 – Freestyle stentless valve
Hancock
Carpentier
Rigid Stent
Carpentier
Flexible Stent
Medtronic
Freestyle
FIRST PORCINE AORTIC VALVE
REPLACEMENT
 In 1965, Jean Binet, M.D. and Alain Carpentier, M.D.,
Ph.D., performed the first aortic valve replacement
using a porcine valve.
 Within 4 years, valves treated with mercurial solutions
and Formalin had frequent failures from
immunological reaction, inflammation, and
denaturation of the tissue.
 Formaldehyde was replace with glutaraldehyde in
1968 to provide more durable cross-linking of the
collagen.
PERICARDIAL BIOPROSTHESES






1971 – Ionescu pericardial valve
1975 – Ionescu-Shiley peri valve
1981 – Mitroflow peri valve
1981 – CE PERIMOUNT 2900, 6900
2002 – ATS 3F Bioprosthesis
2009 – ST JUDE TRIFECTA
TRIFECTA
Ionescu-Shiley
Carpentier-Edwards
PERIMOUNT
ATS 3F
Ionescu
Mitroflow
PERCUTANEOUS





1988 – Andersen valve development
1991 – Alfieri, Edge-to-Edge, Evalve
2000 – Percutaneous Valve Technologies (2002)
2001 – CoreValve (2004)
2008……St. Jude Medical (2011)
Andersen
CoreValve
Alfieri
PVT/Edwards
Aortic Valve Disease: Treatment Options
 Aortic Valve Replacement
 Optimal Medical Therapy
 Transcatheter Aortic Implantation (TAVI)
Transcatheter Valves: TAVI Initial Experiences
 Balloon Expandable and Self Expanding Devices
 Similar results?
 Except heart block/need for pacemaker
 Strong Growth in Transapical recently
 Rapid physician/patient acceptance and market penetration
 Now over 20,000 Implants Worldwide
 Primarily in Europe
Issues with Current Generation Devices
Lack of control and accuracy
in positioning / placement
Valves cannot be fully and safely
re-sheathed or retrieved if needed
Paravalvular leak
Conduction disturbances
St. Jude Medical TAVI Program
Focused on Developing Next Generation
Technology:







Deployment accuracy
Repositioning capability
Re-sheathable / retrievable
Valve durability
Minimize paravalvular leak
Reduce conduction system interference
Ease-of-use
St. Jude Medical TAVI System:
Next Generation Design Features
Unique self expanding
stent design provides the
ability to…
 Re-sheath*
 Reposition
 Retrieve*
… the valve at implant site
Bovine and porcine
pericardial valve with
Anti-calcification
technology **
Anti-calcification technology is used
on SJM Epic™ and Trifecta™***
surgical aortic valves
* Until fully deployed
** There is no clinical data currently available that evaluates the long-term impact of
anticalcification tissue treatment in humans.
*** Trifecta is an investigational device in the US and is not commercially available.
Open stent cell
design allows access
to coronaries and low
crimp profile
Tissue cuff designed
to minimize PV leak
Low placement of
leaflets/cuff within the
stent frame allows for
minimal protrusion into
the LVOT
Limited Placement Into LVOT
Minimal protrusion of
valve into LVOT
St. Jude Medical Transcatheter Delivery Systems
 One valve – two delivery
systems
Transapical
 St Jude Medical system
addresses placement
accuracy with:
 Controlled, annulus first
deployment for ability to assess
valve placement prior to full
deployment
 Ability to reposition (antegrade
or retrograde*) at the implant
site
 Retrieve entire device*, if
needed
* Need to re-sheath
Transfemoral
St. Jude Medical Transcatheter Delivery System
One Valve – Two Delivery Systems
24F
Integrated sheath
24F
Transapical
 Transapical delivery system does not require an external sheath
 Use of an external sheath results in a larger apex puncture site
12F
18F
Transfemoral
Transfemoral delivery system designed for flexibility and trackability
St. Jude Medical Transcatheter Delivery System
 Marker bands address
placement accuracy
 Safety feature is engaged during
deployment
 Valve is functioning after
partial deployment
 After a majority of the valve
has been deployed, can
assess placement of the
valve
 Disengage safety feature to
allow full deployment of the
valve.
St. Jude Medical TAVI Systems
Transapical
St. Jude Medical TAVI Systems
Transfemoral
In-Vitro Valve Testing
Durability Performance Assessment
Circular Configuration
Elliptical Configuration
Videos currently playing in the Conference Hall.
 Accelerated Wear Testing: Tested over the valve’s use
range, and in various annular configurations
Valve in Valve for Degenerated Bioprostheses
Growing Clinical Need
First-in-human attempted mitral valve-in-valve procedure
(Failed)
Webb, J. G. et al. Circulation 2010;121:1848-1857
Copyright ©2010 American Heart Association
Aortic Valve in Valve
TAVI Valves NOT designed with Valve in Valve in Mind
Webb, J. G. et al.
Circulation 2010;121:1848-1857
Transapical implantation of a balloon-expandable THV in a patient with
stenosis of the native aortic valve
Summary
The St. Jude Medical TAVI design addresses the limitations
of early generation devices:
Placement
accuracy and
controlled
deployment
Repositionable,
antegrade and
retrograde*, at
implant site
* Needs to be re-sheathed for retrograde repositioning
** Until fully deployed
Retrievable**
Reduce
conduction
system
interference
Panel for Q&A

Patients - St. Jude Medical

Transcription

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