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AIM-RADIAL
New York City
September 27, 2013

Josiah N. Wilcox, Ph.D.
Chief Scientific Officer
Coronary and RDN
Medtronic CardioVascular
Disclosures
• Full time employee of Medtronic CardioVascular
• I will be talking about experimental DES and
devices for RDN that are under investigation and
not currently approved for clinical use.
Collaborating with
Physicians to Develop
Life-Changing
Therapies
Global Leader in Medical Technology

46,000+

employees, making us the largest
global medical technology company

5,800+

scientists and engineers
around the world

1,500+

FY13 patents awarded, bringing our
total worldwide to more than 28,000

$16.6B

FY13 global sales from continuing
operations which generate $3.9B
in free cash flow*

~45%
* Free cash flow is operating cash flow minus capital expenditures

sales from international markets,
representing more than 140 countries
Diverse Revenue Sources

Cardiac Rhythm
Disease Management

Coronary

11%

30%

Structural
Heart

7%
Endovascular Therapies

5%

Surgical
Technologies

Diabetes

9%

9%

Neuromodulation

11%

Spine

19%

Based on FY2013 revenues of $16.6 billion. The data in this schedule has been intentionally rounded to the nearest
whole percentage and therefore does not sum to 100%.
Hospital management faced with need
to improve efficiency
European Market Research 2012; 59 C-Suite members in 34 hospitals

Pressure on budgets
•

Economic crisis impacts
health care & hospital
management

•

Budgets closely
monitored
by government / payer

•

Evaluate current system
& find new ways to attract
resources

Increased expectations
• From patients to get
best care
• From Medical professionals
to get access to latest treatment
options & develop of personal
career
• Government & Public monitor
quality of care
Towards Healthcare Solution Provider
Medtronic buys Cardiocom, Expands Into Disease Management
Wall Street Journal-Online August 11, 2013
Medtronic Inc. said it has acquired Cardiocom LLC, a closely held disease-management and patientmonitoring firm, in a move that the device maker hopes will turn increasing concerns about health spending to
its advantage.
The $200 million, all-cash deal puts Medtronic in the business of working with hospitals and insurers to limit
the costs of treating patients with chronic diseases, such as heart failure and diabetes, and gives it a hand in
the care of patients who don't need costly, high-tech implantable devices that are Medtronic's core offerings.

Heart Failure

Hypertension

Initial MDT Focus

Simple
Monitoring
Devices

CAD
Enterprise
Software

Nurse Call
Center

Diabetes

Pain
Strategies to Address Healthcare Needs
Universal
Healthcare Needs

Strategies
New Therapies Develop new therapies and technologies

Improve clinical
outcomes

to address unmet clinical needs and
drive them to standard of care

Globalization
Expand access

Optimize cost
and efficiency

Develop tailored solutions to address
market-specific needs and expand
access in global markets

Economic Value Translate the clinical value of therapies,
programs and services into economic
benefits for the health care system
Economic Value Framework

IMPROVE
OUTCOMES

EXPAND
ACCESS

OPTIMIZE
COST &
EFFICIENCIES

• Quality of clinical
evidence
• Treatment
guidelines

• Quality of clinical
evidence
• Quality measures
• Readmissions

• Quality of clinical
evidence (HTA)
• Reduced
complications

• Physician
reimbursement
• Ease of use

• Financial performance • Patient satisfaction
• Reputation/Competitive• Physician support
advantage

• Patient
satisfaction
• Invasiveness

• Procedure
efficiency

• Procedure efficiency
• Device price

• Affordability
/Liquidity

• Cost effectiveness
• Budget impact

• Quality of Life
• Mortality benefit
Integrity™ and Resolute Integrity™
A New Standard in Stent Design and Manufacturing
Conventional Stent Design

Medtronic Modular Design

Vs.
Slotted Tube

Modular Design

Medtronic’s Continuous Sinusoid Technology

Sinusoidal Formed Wire

Helical Wrap

Laser Fused
Stent Design

Integrity Platform

Continuous Flexibility Due to Unique Sinusoidal Design
DES

“Box car” or coupler

Continuous sinusoid

115° bend

Sinusoidal-formed wire

Helical wrap

Laser-fused
Resolute Integrity DES Deliverability
Superior Deliverability*
100
90

Average Push Force (gf)

Lower is Better

86

80
70
60

69

50
40
30

20

20
10
0
Promus Element DES
2.50 mm x 20 mm

Xience Prime DES
2.50 mm x 18 mm

DES

* Based on 3D tracking bench test data on file at Medtronic, Inc.

Resolute Integrity DES
2.50 mm x 18 mm
Resolute™ DES Resulted in 6% Fewer Stents per Patient
For a hospital performing 1,000 DES cases a
in a Large Real-World Trial vs. Xience V™ DES

year, the 6% reduction results in 116 fewer stents
and $174,000 Stents per product savings.
# in direct Patient
2.5

6% Fewer Stents p=0.02

# of Stents per Patient

2.0

2.02

1.9
1.5
1.0

p = 0.02

0.5
0

Resolute DES Xience V DES
Resolute™ DES
Xience V™ DES
n=1152
n=1140
n = 1140
n = 1152

• Large, international, randomized controlled trial in real-world patient population
• Similar patient populations, baseline demographics and lesion characteristics
* Results

from RESOLUTE All Comers trial. Serruys et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010;363:136-146.
Unique Continuous Sinusoid Technology
Enables New Stent Constructions
Continuous
Sinusoid
Technology

Conventional
Stent Design

Uniform Cross-Section
Wire

Resolute
Integrity

TM

Core Wire

Core Wire, Decore,
and Hole Drilling

Core Wire Stent

Drug Filled Stent

New Alloys

Metal
Bioabsorbable
Symplicity™ System Designed
Specifically for RDN

Symplicity™ Catheter:
• 6 F compatible
• Designed for safe, targeted therapy
delivery
• Self-orienting tip for confident, atraumatic
vessel contact

Symplicity™ Generator:
• Sophisticated automatic control
mechanisms to maximize safety
• Constantly adjusts therapy based on
feedback from the catheter tip
• Capable of adjusting therapy within 0.001
sec based on feedback
• Hands-free pedal activation
Symplicity Spyral™ Multi-Electrode
Renal Denervation Catheter
Design Goal

Reduce procedural time while maintaining similar clinical
outcomes and reassurance of success compared to original and
proven Symplicity Flex™ Catheter

Symplicity
Spyral Product
Features








1 minute ablation cycle
4 electrodes, independently selectable
6F guide catheter compatible
Non-occlusive
Natural conformability
Rapid exchange
Cost/QALY Comparison
Threshold
$50k

Geisler, B.P. et al. JACC 60(1271)2012
Transradial Economic Value
Average Savings per PCI ($550-$830)
~12% due to bleeding risk
~50% due to shorter length of stay (0.3-0.38 day)

US hospitals have potentially saved
$90 million annually by moving from
2% to 20% TRA adoption

1800
High Bleeding Risk

Adjusted Cost Savings per Procedure

1600

In Procedure Costs

1400

Post-Procedure Costs

1200
1000
$1,621

800
600
$1,046
400

$705

$571
200
0
-200

($17)
Average

Opportunities for Medtronic

$130
High Risk

Premier Database (2004-9)

Average

High Risk

5 Center US Study (2010-11)

1. Partner to develop training programs
and share best practices
2. Develop products to further increase
procedural success

Premier Database: n=609 TRA, 60,900 TFA; AmHeartJ (2013)
5 Center US Study: n=1,219 TRA, 5,902 TFA; JACC-CardioInt (2013)
US TRA rates were estimated at 2% in 2009 and 20% in 2013 Circulation (2013)
Global healthcare trends are driving increased
adoption of transradial access
90%

Anticipated Transradial Penetration*

80%
70%

60%

United States

50%

WECA
China

40%

India

30%

Japan
ROW

20%
10%

0%
FY11

FY12

FY13

FY14

FY15

FY16

FY17

FY18

FY19

Strategic opportunity for Medtronic to expand access,
improve outcomes, and increase efficiencies
* Internal Analysis
Facilitating Transradial Adoption
Clinical Education:

Patient Education:

Hospital Marketing Tools:

Proctorships, Preceptorships, &
Training Modules

Treatment Options

Awareness Campaigns
Transradial PCI Program Portfolio
Multi-tiered, targeted approach across learning spectrum
•

Speaker programs that facilitate peer-to-peer interaction
on the transradial approach and support the continual
improvement of patient care

•

Comprehensive curriculum developed for Interventional
Cardiology nurses and technicians
1 credit offered for TRA

MFE

CEU
•
•

Medtronic-sponsored summits that focus on didactic
presentations covering all the aspects of the transradial
procedure

•

Provides a group of 3-4 attendees with opportunity to
travel to a transradial clinical expert’s cath lab/institution
and have them observe him/her in clinic for one day

•

Provides a cath lab/institution with an opportunity to host
and work with a transradial clinical expert for a day in their
own facilities

TRA Summits

Preceptorship

Proctorship

22
A commitment to Transradial Education
•
•
•

•

•

Supported over 10 national summits in the past three years
• Over 500 physicians trained
Completed over 50 preceptorship/proctorship programs
• Over 1400 physicians trained
Medtronic Faculty Educators – 40% of speakers are dedicated to transradial
• 160 events per year
• Average of 8 physicians per event
• Over 1200 physicians trained
Cath Lab Manager Summit
• Over 300 managers trained in the past year
Over 3000 physicans/staff trained in the past year!!

23
All Part of Comprehensive Program Suite
Clinical Training
& Support
Transradial

CEU
Programs

Healthcare
Economic Services
Health Economics
Policy Updates
Case &
Payment
Reviews

Fellows
Training
Reimbursement &
Coding Education
Medtronic
Faculty
Educators

Outreach &
Patient Education

Peer-to-Peer
Engagement
CV
Executive
Summits*

Patient &
Physician
Outreach
Programs*

Cath Lab
Manager
Summits*

Disease
Management
& Disparities
Education

Cath Lab
Champions

Benchmark
Data

Patient Education
“Kit,” w/ DAPT Info

LIFELINE
Technical
Hotline

24
Products and Therapies
Develop new therapies and technologies
to address unmet clinical needs and drive
them to standard of care

Launcher Guide Catheters
• Large lumens with no performance
tradeoffs
• Flexible distal segment to engage
the guide for backup
• Supportive secondary curve

Sherpa NX Guide Catheters
• Two distal segments to provide options for guide
engagement
• Soft tip and distal sleeve to facilitate ease of
engagement
• Advanced HDPE liner for smooth, low-friction
device passage
Guide Catheter Lines
Unique Full-Wall Technology

Inner and outer jackets
encapsulate flat braid
wires, affording thinner,
stronger, walls.

Optimizes balance
between large lumen and
robust performance.

Dedicated Radial Curves
Designed to provide backup support and easy
engagement.
Many New Opportunities to Consider
Micropuncture access

Closure bands

Sheathless guides

Guide catheters

Arm supports
Peripheral procedures
Diagnostic catheters

Renal denervation procedures

Embolic protection

CTO solutions

Rx support catheters
Wires and balloons
Thank You

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Wilcox JN - AIMRADIAL 2013 - Medtronic perspective

  • 1. AIM-RADIAL New York City September 27, 2013 Josiah N. Wilcox, Ph.D. Chief Scientific Officer Coronary and RDN Medtronic CardioVascular
  • 2. Disclosures • Full time employee of Medtronic CardioVascular • I will be talking about experimental DES and devices for RDN that are under investigation and not currently approved for clinical use.
  • 3. Collaborating with Physicians to Develop Life-Changing Therapies
  • 4. Global Leader in Medical Technology 46,000+ employees, making us the largest global medical technology company 5,800+ scientists and engineers around the world 1,500+ FY13 patents awarded, bringing our total worldwide to more than 28,000 $16.6B FY13 global sales from continuing operations which generate $3.9B in free cash flow* ~45% * Free cash flow is operating cash flow minus capital expenditures sales from international markets, representing more than 140 countries
  • 5. Diverse Revenue Sources Cardiac Rhythm Disease Management Coronary 11% 30% Structural Heart 7% Endovascular Therapies 5% Surgical Technologies Diabetes 9% 9% Neuromodulation 11% Spine 19% Based on FY2013 revenues of $16.6 billion. The data in this schedule has been intentionally rounded to the nearest whole percentage and therefore does not sum to 100%.
  • 6. Hospital management faced with need to improve efficiency European Market Research 2012; 59 C-Suite members in 34 hospitals Pressure on budgets • Economic crisis impacts health care & hospital management • Budgets closely monitored by government / payer • Evaluate current system & find new ways to attract resources Increased expectations • From patients to get best care • From Medical professionals to get access to latest treatment options & develop of personal career • Government & Public monitor quality of care
  • 8. Medtronic buys Cardiocom, Expands Into Disease Management Wall Street Journal-Online August 11, 2013 Medtronic Inc. said it has acquired Cardiocom LLC, a closely held disease-management and patientmonitoring firm, in a move that the device maker hopes will turn increasing concerns about health spending to its advantage. The $200 million, all-cash deal puts Medtronic in the business of working with hospitals and insurers to limit the costs of treating patients with chronic diseases, such as heart failure and diabetes, and gives it a hand in the care of patients who don't need costly, high-tech implantable devices that are Medtronic's core offerings. Heart Failure Hypertension Initial MDT Focus Simple Monitoring Devices CAD Enterprise Software Nurse Call Center Diabetes Pain
  • 9. Strategies to Address Healthcare Needs Universal Healthcare Needs Strategies New Therapies Develop new therapies and technologies Improve clinical outcomes to address unmet clinical needs and drive them to standard of care Globalization Expand access Optimize cost and efficiency Develop tailored solutions to address market-specific needs and expand access in global markets Economic Value Translate the clinical value of therapies, programs and services into economic benefits for the health care system
  • 10. Economic Value Framework IMPROVE OUTCOMES EXPAND ACCESS OPTIMIZE COST & EFFICIENCIES • Quality of clinical evidence • Treatment guidelines • Quality of clinical evidence • Quality measures • Readmissions • Quality of clinical evidence (HTA) • Reduced complications • Physician reimbursement • Ease of use • Financial performance • Patient satisfaction • Reputation/Competitive• Physician support advantage • Patient satisfaction • Invasiveness • Procedure efficiency • Procedure efficiency • Device price • Affordability /Liquidity • Cost effectiveness • Budget impact • Quality of Life • Mortality benefit
  • 11. Integrity™ and Resolute Integrity™ A New Standard in Stent Design and Manufacturing Conventional Stent Design Medtronic Modular Design Vs. Slotted Tube Modular Design Medtronic’s Continuous Sinusoid Technology Sinusoidal Formed Wire Helical Wrap Laser Fused
  • 12. Stent Design Integrity Platform Continuous Flexibility Due to Unique Sinusoidal Design DES “Box car” or coupler Continuous sinusoid 115° bend Sinusoidal-formed wire Helical wrap Laser-fused
  • 13. Resolute Integrity DES Deliverability Superior Deliverability* 100 90 Average Push Force (gf) Lower is Better 86 80 70 60 69 50 40 30 20 20 10 0 Promus Element DES 2.50 mm x 20 mm Xience Prime DES 2.50 mm x 18 mm DES * Based on 3D tracking bench test data on file at Medtronic, Inc. Resolute Integrity DES 2.50 mm x 18 mm
  • 14. Resolute™ DES Resulted in 6% Fewer Stents per Patient For a hospital performing 1,000 DES cases a in a Large Real-World Trial vs. Xience V™ DES year, the 6% reduction results in 116 fewer stents and $174,000 Stents per product savings. # in direct Patient 2.5 6% Fewer Stents p=0.02 # of Stents per Patient 2.0 2.02 1.9 1.5 1.0 p = 0.02 0.5 0 Resolute DES Xience V DES Resolute™ DES Xience V™ DES n=1152 n=1140 n = 1140 n = 1152 • Large, international, randomized controlled trial in real-world patient population • Similar patient populations, baseline demographics and lesion characteristics * Results from RESOLUTE All Comers trial. Serruys et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010;363:136-146.
  • 15. Unique Continuous Sinusoid Technology Enables New Stent Constructions Continuous Sinusoid Technology Conventional Stent Design Uniform Cross-Section Wire Resolute Integrity TM Core Wire Core Wire, Decore, and Hole Drilling Core Wire Stent Drug Filled Stent New Alloys Metal Bioabsorbable
  • 16. Symplicity™ System Designed Specifically for RDN Symplicity™ Catheter: • 6 F compatible • Designed for safe, targeted therapy delivery • Self-orienting tip for confident, atraumatic vessel contact Symplicity™ Generator: • Sophisticated automatic control mechanisms to maximize safety • Constantly adjusts therapy based on feedback from the catheter tip • Capable of adjusting therapy within 0.001 sec based on feedback • Hands-free pedal activation
  • 17. Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Design Goal Reduce procedural time while maintaining similar clinical outcomes and reassurance of success compared to original and proven Symplicity Flex™ Catheter Symplicity Spyral Product Features       1 minute ablation cycle 4 electrodes, independently selectable 6F guide catheter compatible Non-occlusive Natural conformability Rapid exchange
  • 19. Transradial Economic Value Average Savings per PCI ($550-$830) ~12% due to bleeding risk ~50% due to shorter length of stay (0.3-0.38 day) US hospitals have potentially saved $90 million annually by moving from 2% to 20% TRA adoption 1800 High Bleeding Risk Adjusted Cost Savings per Procedure 1600 In Procedure Costs 1400 Post-Procedure Costs 1200 1000 $1,621 800 600 $1,046 400 $705 $571 200 0 -200 ($17) Average Opportunities for Medtronic $130 High Risk Premier Database (2004-9) Average High Risk 5 Center US Study (2010-11) 1. Partner to develop training programs and share best practices 2. Develop products to further increase procedural success Premier Database: n=609 TRA, 60,900 TFA; AmHeartJ (2013) 5 Center US Study: n=1,219 TRA, 5,902 TFA; JACC-CardioInt (2013) US TRA rates were estimated at 2% in 2009 and 20% in 2013 Circulation (2013)
  • 20. Global healthcare trends are driving increased adoption of transradial access 90% Anticipated Transradial Penetration* 80% 70% 60% United States 50% WECA China 40% India 30% Japan ROW 20% 10% 0% FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 Strategic opportunity for Medtronic to expand access, improve outcomes, and increase efficiencies * Internal Analysis
  • 21. Facilitating Transradial Adoption Clinical Education: Patient Education: Hospital Marketing Tools: Proctorships, Preceptorships, & Training Modules Treatment Options Awareness Campaigns
  • 22. Transradial PCI Program Portfolio Multi-tiered, targeted approach across learning spectrum • Speaker programs that facilitate peer-to-peer interaction on the transradial approach and support the continual improvement of patient care • Comprehensive curriculum developed for Interventional Cardiology nurses and technicians 1 credit offered for TRA MFE CEU • • Medtronic-sponsored summits that focus on didactic presentations covering all the aspects of the transradial procedure • Provides a group of 3-4 attendees with opportunity to travel to a transradial clinical expert’s cath lab/institution and have them observe him/her in clinic for one day • Provides a cath lab/institution with an opportunity to host and work with a transradial clinical expert for a day in their own facilities TRA Summits Preceptorship Proctorship 22
  • 23. A commitment to Transradial Education • • • • • Supported over 10 national summits in the past three years • Over 500 physicians trained Completed over 50 preceptorship/proctorship programs • Over 1400 physicians trained Medtronic Faculty Educators – 40% of speakers are dedicated to transradial • 160 events per year • Average of 8 physicians per event • Over 1200 physicians trained Cath Lab Manager Summit • Over 300 managers trained in the past year Over 3000 physicans/staff trained in the past year!! 23
  • 24. All Part of Comprehensive Program Suite Clinical Training & Support Transradial CEU Programs Healthcare Economic Services Health Economics Policy Updates Case & Payment Reviews Fellows Training Reimbursement & Coding Education Medtronic Faculty Educators Outreach & Patient Education Peer-to-Peer Engagement CV Executive Summits* Patient & Physician Outreach Programs* Cath Lab Manager Summits* Disease Management & Disparities Education Cath Lab Champions Benchmark Data Patient Education “Kit,” w/ DAPT Info LIFELINE Technical Hotline 24
  • 25. Products and Therapies Develop new therapies and technologies to address unmet clinical needs and drive them to standard of care Launcher Guide Catheters • Large lumens with no performance tradeoffs • Flexible distal segment to engage the guide for backup • Supportive secondary curve Sherpa NX Guide Catheters • Two distal segments to provide options for guide engagement • Soft tip and distal sleeve to facilitate ease of engagement • Advanced HDPE liner for smooth, low-friction device passage
  • 26. Guide Catheter Lines Unique Full-Wall Technology Inner and outer jackets encapsulate flat braid wires, affording thinner, stronger, walls. Optimizes balance between large lumen and robust performance. Dedicated Radial Curves Designed to provide backup support and easy engagement.
  • 27. Many New Opportunities to Consider Micropuncture access Closure bands Sheathless guides Guide catheters Arm supports Peripheral procedures Diagnostic catheters Renal denervation procedures Embolic protection CTO solutions Rx support catheters Wires and balloons

Editor's Notes

  1. Increasingly, Earl was asked to not just repair equipment, but to make it more effective. Being an inventor at heart, Earl was more than happy to collaborate and come up with something better. One of Medtronic’s most famous collaborations was in 1957. Well-known University of Minnesota cardiac surgeon Dr. C. Walton Lillehei asked Earl to create a battery-operated pacemaker. At the time, pacemakers were bulky, external boxes that sat on a cart and had to be plugged into a wall socket. But what happened if there was a power outage? Dr. Lillehei wanted a more reliable pacemaker, and Earl created one … making history and transforming Medtronic from a medical equipment REPAIRER to a MANUFACTURER.
  2. Should we switch to Flex photo?
  3. Press kit for hospitals to market TRA program. **Likely not as relevant for China**Pamphlet for patients to explain advantagesMAC3030 curve shape designed by a physician for universal use (diagnostic and intervention with 1 catheter)Universal catheters important to reduce procedure time, # of catheters used, radiation exposure timeTerumo: TIGER, JACKYMAC3030 is a hybrid of both (similar to the JACKY type tip)MAC3030 Launcher 5F used for diagnostic and interventional proceduresSpecialty curve for experienced operatorsNOTE: not the MAC30