Wilcox JN - AIMRADIAL 2013 - Medtronic perspective


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  • 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.
  • Should we switch to Flex photo?
  • 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
  • Wilcox JN - AIMRADIAL 2013 - Medtronic perspective

    1. 1. AIM-RADIAL New York City September 27, 2013 Josiah N. Wilcox, Ph.D. Chief Scientific Officer Coronary and RDN Medtronic CardioVascular
    2. 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. 3. Collaborating with Physicians to Develop Life-Changing Therapies
    4. 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. 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. 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
    7. 7. Towards Healthcare Solution Provider
    8. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
    18. 18. Cost/QALY Comparison Threshold $50k Geisler, B.P. et al. JACC 60(1271)2012
    19. 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. 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. 21. Facilitating Transradial Adoption Clinical Education: Patient Education: Hospital Marketing Tools: Proctorships, Preceptorships, & Training Modules Treatment Options Awareness Campaigns
    22. 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. 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. 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. 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. 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. 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
    28. 28. Thank You