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Rhythm ManagementCardiac Rhythm Management (CRM) and
Electrophysiology (EP)
HRS Update
Joe FitzgeraldExecutive Vice President and President,
Rhythm Management
Ken Stein, M.D.Senior Vice President and CMO,
Rhythm Management
Mark BickelVP Finance & Global Controller,
Rhythm Management
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Safe Harbor for Forward-Looking Statements
This presentation contains forward‐looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward‐looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward‐looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could differ materially from the expectations and projections expressed or implied by our forward‐looking statements.
Factors that may cause such differences can be found in our most recent Form 10‐K and Forms 10‐Q filed or to be filed with the Securities and Exchange Commission under the headings “Risk Factors” and “Safe Harbor for Forward‐Looking Statements.” Accordingly, you are cautioned not to place undue reliance on any of our forward‐looking statements. We disclaim any intention or obligation to publicly update or revise any forward‐looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which they may be based, or that may affect the likelihood that actual results will differ from those contained in the forward‐looking statements.
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Rhythm Management Offers a Broad Portfolio of Innovative Products and Solutions in Large Markets
Clinical Evidence
Patient Management
Diagnostics & Monitoring Cardiac Rhythm Management
Modular CRM Systems
Mapping & AblationLeft Atrial Appendage Closure
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Agenda
• High Voltage Portfolio Update
• Electrophysiology and Rhythmia Commercialization
• HRS Clinical Highlights
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CRM Next Gen: RESONATE Family of High Voltage Devices4 key feature sets; 1st & only to offer EnduraLife™ & HeartLogic ™
EnduraLife™ Battery Technology
HeartLogic™ Heart Failure DiagnosticsSmartCRT™ Therapy(incl. Multi‐Site Pacing)
MRI Conditional Labeling*21
3 4
Expect U.S. Approval Q4:2017
* Not approved in the U.S.
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EnduraLife™ Battery TechnologyIndustry leading longevity
“…The case for adopting EnduraLife-powered cardiac resynchronisation therapy-defibrillator (CRT-D) devices for treating heart failure is supported by the published evidence. Extended
battery life is of clinical and patient benefit and associated with fewer replacement procedures. […]EnduraLife-powered CRT-Ds should be considered as an option in people
offered CRT-D devices…”- Excerpt from Evidence-based recommendations on ENDURALIFE-powered CRT-D devices for treating heart failure, published March 2017
Over 8 years of commercial experience and 9 published studies demonstrate the industry-leading performance of
* See Reference #2
* See Reference #3
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U.S. MRI Conditional Labeling TimelinesLast major market gap (U.S. High Voltage) targeted YE17
TV High Voltage
S-ICD
Low Voltage
2017E 2018+E2016
ACCOLADE MRI ESSENTIO MRI
INGEVITY
CRT-P
EL/MINI ICDs, X4 CRT-Ds
(DYN/INO Family & RESONATE Family)
RELIANCE 4-SITEACUITY X4
RESONATE Family ICDs & CRT-Ds
RELIANCE 4-FRONTACUITY X4
IS1/DF1 Replacement ICDs & CRT-Ds
1.5T
1.5T
EMBLEM & EMBLEM MRI
1.5T
EMBLEM MRI
ACCOLADE MRI ESSENTIO MRI
INGEVITY1.5T
FINELINE II
1.5T
U.S. Estimate: Q4 17
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SmartCRT™ Therapy Provides 3 Key Feature SetsQuad pole pacing, Smart Delay, and MultiSite Pacing (MSP)
SmartCRT = 3 key CRT-D feature sets that will drive BSX share gains
+ ACUITY™ X4 Lead
SmartDelay™ACUITY™ X4 LeadsLV VectorGuide™
Where to pace
Site of latest activation
Whento pace
Maximize global contractility
How to pace
Options to maximize response
Labeled for up to 13.3 years1
longevity with MultiSite Pacing ON
MultiSite Pacing
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HeartLogic™: HF Diagnostics with Trending & Alerts Significant “referral-driven” share gain opportunities
HeartLogic™ will be available in the RESONATE family of HV devices
Heart Logic Results:• 70% Sensitivity in Detecting HF Events• 34 Days Median time to HF Event• Only 1.47 Unexplained Alerts per Patient Year
HeartLogic™ Heart Failure Diagnostic Service
Algorithm evaluates risk and changes from patient baseline across multiple parameters
Integrated into a simple index with customizable alert
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HeartLogic™: Improving Patient Care & Driving Share
Clinical Outcomes
Supported by a Robust Program of Clinical Evidence
MANAGE-HFMANAGE-HF
2017 2018 2019 2020
HeartLogic™ RegistryHeartLogic™ RegistryReal World Experience
Reimbursement & Cost-Effectiveness Pilots Reimbursement & Cost-Effectiveness Pilots Economic Outcomes
Improve HF Patient Care
Predictive & Population Analytics
Sensor & Data Management Platforms
Care Coordination
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Agenda
• High Voltage Portfolio Update
• Electrophysiology and Rhythmia Commercialization
• HRS Clinical Highlights
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Electrophysiology Portfolio Emerging to Drive Growth > Market
ElectrophysiologyPortfolio
Therapeutic Catheters
EP Recording Systems
Mapping and Navigation
Diagnostic Catheters RHYTHMIA HDx™
MAPPING SYSTEMRHYTHMIA HDx™ MAPPING SYSTEM
INTELLAMAP ORIONMapping CatheterINTELLAMAP ORIONMapping Catheter
Navigation & MIFIAblation CathetersNavigation & MIFIAblation Catheters
LAB SYSTEM PROrecording systemLAB SYSTEM PROrecording system
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RHYTHMIA™ Mapping SystemDriving Placements & Share Gains
5x fasterMAPPING5
25x theDATA POINTS5
0.01mVNOISE THRESHOLD5
Setting the Standard in High Definition Mapping
Active in > 25 countries, with more slated to launch over the next two years
>50 Peer-ReviewedJOURNAL ARTICLES
>10,000 WorldwideCASES
Exponentially more data
See detail never seen before
More accurate and complete mapping
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Agenda
• High Voltage Portfolio Update
• Electrophysiology and Rhythmia Commercialization
• HRS Clinical Highlights
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Broad Portfolio of Compelling BSX Data at HRSS-ICD, CRT-D & ICD, Watchman™ and EP products highlighted
Thursday, May 11
S‐ICD SystemLate‐Breaking Clinical Trial: The S‐ICD Post‐market Approval Study: Michael R. Gold, M.D., Ph.D, FHRS, will present at 8:00 AM in room 375E.
Evaluation of an Automatic Screening Tool for S‐ICD Patient Selection: A poster authored by Venugopal Allavatam,MS, will be available for viewing from 9:30 AM ‐12:00 PM in Epicenter, Exhibit Hall.
CRT‐D and ICDRight Ventricular Lead Location, Right‐Left Ventricular Lead Interaction, and Long‐Term Mortality in Cardiac Resynchronization Therapy Patients: Usama Daimee, M.D., will present at 2:30 PM in room 186.
Multiple Procedures Increase the Risk of Infection but Not Mechanical Complications in Patients with Implantable Cardiac Defibrillators: Jayanthi N. Koneru, MBBS, will present at 2:45 PM in Room 375D.
Friday, May 12
WATCHMAN LAAC DeviceLate‐Breaking Clinical Trial: EWOLUTION trial: 1‐Year Efficacy and Safety of Left Atrial Appendage Closure with WATCHMAN in Patients with or without Contraindication to Oral Anticoagulation: Lucas V. A. Boersma, M.D., Ph.D, will present at 11:00 AM in Room 375E.
S‐ICD SystemChronic performance of Communicating Leadless Anti‐Tachycardia Pacemaker and Subcutaneous Implantable Cardioverter Defibrillator: Fleur V.Y. Tjong, M.D., will present at 1:30 PM in Room 375D.
Propensity Score Matched Comparison of Subcutaneous and Transvenous Implantable Defibrillator Therapy in the SIMPLE and EFFORTLESS studies: A poster authored by Tom F. Brouwer, M.D. and Jeffrey S. Healey, M.D., FHRS, will be available for viewing from 2:00 PM – 5:00 PM in Epicenter, Exhibit Hall.
CRT‐D and ICDExtended Follow‐Up of a Family of Anatomically Designed Quadripolar Left Ventricular Leads: A poster authored by Suneet Mittal, M.D., FHRS, will be available for viewing from 2:00 PM – 5:00 PM in Epicenter, Exhibit Hall.
Electrophysiology*Local impedance via mini electrodes successfully measures catheter‐tissue contact and is strongly correlated to radiofrequency lesion dimensions in explanted swine hearts: A poster authored by Matthew S. Sulkin, Ph.D, will be available for viewing from 2:00 PM – 5:00 PM in Epicenter, Exhibit Hall.
Local impedance via mini electrodes as an in vivo indicator of catheter‐tissue coupling and lesion maturation: Jacob I. Laughner, Ph.D., will present at 3:15 PM in Epicenter, Exhibit Hall.
*over 18 independent abstracts on the Rhythmia™Mapping System
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WORLD’S LARGEST PROSPECTIVE STUDY OF THE S-ICD SYSTEM
HRS LBCT, Thursday May 11th, 8:00 am, Dr. Michael Gold
Largest S-ICD study to date
1637 patients from 86 centers in the US
Population more similar to TV-ICD populations, and higher comorbidities
“Mainstream” indications: 66.6% Primary Prevention, low EF patients
Excellent Acute Outcomes
98.7% success in acute conversion of VT/VF arrhythmias
Complication-free rate of 96.2% at 30 days
S-ICD Post-Approval Study: LBCT 5/11 8:00am“Mainstream” indications and excellent acute outcomes
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First report of efficacy results from the EWOLUTION Prospective
Registry at 2 Late-Breaking Clinical Trial Sessions
HRS Friday, May 12th, 11am* Chicago, IL USA
EuroPCR Thursday, May 19th, 11:47am* Paris, FRANCE
EWOLUTION Registry: >1000 patients, 47 centers in 13 countries
Throughout Europe, the Middle East, and Russia
HRS: 1-year outcomes in the overall trial population
EuroPCR: Results in the warfarin-ineligible cohort
focusing on treatment options in these patients
WATCHMANTM LAAC: LBCT 5/12 11:00am EWOLUTION Prospective Registry – data at HRS & EuroPCR
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References
Reference #1 Assumes: 2.0V RA, LV-only, 2.0V LVa, 2.0V LVb, 700Ω, No LATITUDE, No Respiratory Rate Sensor, No Heart Failure Sensor Suite
Reference #2 Landolina M, Curnis A, Morani G, Vado A, Ammendola E, D’onofrio A, Stabile G, Crosato M, Petracci B, Ceriotti C, Bontempi L, Morosato M, Ballari GP, Gasparini M. Longevity of implant Cardioverter-defibrillators for cardiac resynchronization therapy in current clinical practice: an analysis according to influencing factors, device generation, and manufacturer. Europace2015;17:1251-58. doi:10.1093/eurospace/euv109. First published online: May 14, 2015. Medtronic = 532 patients, Boston Scientific = 291 patients, St. Jude Medical = 106 patients, Biotronik = 20 patients, Sorin = 69. Five-year survival rate of latest marketed devices (between 2006 to 2010) calculated using device replacements for battery depletion as indicated by ERI.
Reference #3 1. Haarbo J, Hjortshoj S, Johansen J, Jorgensen O, Nielsen J, Petersen H. Device Longevity in Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillators Differs Between Manufacturers: Data from the Danish ICD Registry. Presented at HRS 2014. http://ondemand.hrsonline.org/common/presentation-detail.aspx/15/35/1241/9000. Boston Scientific = 136 patients, Medtronic = 651 patients, St. Jude Medical = 1,587 patients, Bitronik = 369 patients. Time to exchange of the device because of battery depletion or device failure recorded in the Danish ICD Registry was the endpoint. The four-year survival rate for devices in the Danish Registry study was 81.1% for Medtronic and 95.7% for Boston Scientific (P<0.01).
2. J. Williams, R. Stevenson. Contemporary cardiac resynchronization implantable cardioverter defibrillator battery longevity in a community hospital heart failure cohort. Presented at HFSA 2014. http://www.onlinejcf.com/article/. S1071-9164(14)00389-3/fulltext. Boston Scientific = 53 patients, Medtronic = 28 patients, St. Jude Medical = 10 patients. Four-year survival rate calculated using device replacements for battery depletion as indicated by ERI.
3. Ellis CR, Dickerman DI, Orton JM, Hassan S, Good EG, Okabe T, Andruilli JA, Quan KJ, Greenspon AJ. Ampere Hour as a Predictor of Cardiac Resynchronization Defibrillator Pulse Generator Battery Longevity: A Multicenter Study. PACE 2016 doi: 10.1111/pace.12831 first published online 11-MAR-2016. The five major institutions performing the study include, at Vanderbilt University, Henry Ford Hospital, University of Michigan, Thomas Jefferson University, Cooper Health System, North Ohio Heart Center. Boston Scientific = 322 patients, Medtronic = 794 patients, St. Jude Medical = 186 patients. Five-year survival rate calculated using device replacements for battery depletion as indicated by ERI.
4. Landolina M, Curnis A, Morani G, Vado A, Ammendola E, D’onofrio A, Stabile G, Crosato M, Petracci B, Ceriotti C, Bontempi L, Morosato M, Ballari GP, Gasparini M. Longevity of implant Cardioverter-defibrillators for cardiac resynchronization therapy in current clinical practice: an analysis according to influencing factors, device generation, and manufacturer. Europace2015;17:1251-58. doi:10.1093/eurospace/euv109. First published online: May 14, 2015. Medtronic = 532 patients, Boston Scientific = 291 patients, St. Jude Medical = 106 patients, Biotronik = 20 patients, Sorin = 69. Five-year survival rate of latest marketed devices (between 2006 to 2010) calculated using device replacements for battery depletion as indicated by ERI.
5. Zanon F, Martignani C, Ammendola E, Menardi E, Narducci ML, De Filippo P, Santamaria M, Campana A, Stabile G, Potenza DR, Pastore G, Iori M, La Rosa C, and Biffi M. Device Longevity in a Contemporary Cohort of ICD/CRT-D Patients Undergoing Device Replacement. Doi:10.1111/jce.12990, First published online 20-APR-2016. Comparison of device longevity by Kaplan-Meier curves of CRT-D systems extracted between March 2013 and May 2015. Medtronic = 195 patients, Boston Scientific = 157 patients, St. Jude = 72, Biotronik = 9.
6. Provided by Dr. Ernest Lau on 04/29/15 in support of Lau E, Wilson C, Ashfield K, McNair W, McEneany D, Roberts M, Large Capacity LiMnO2 Batteries Extended CRTD Longevity in Clinical Use Compared to Smaller Capacity LiSVO Batteries Over 6 Years. Presented at HRS 2015. Medtronic = 62 patients, Boston Scientific = 27 patients, St. Jude = 66 patients. Five-year survival rate calculated using device replacements for battery depletion as indicated by ERI.
7. von Gunten S, Schaer BA, Yap SC, Szili-Torok T, Kühne M, Sticherling C, Osswald S, Theuns DA. Longevity of implantable cardioverter defibrillators: a comparison among manufacturers and over time. Europace. 2015 Nov 25; . Epub 2015 Nov 25. Total patients = 3436.
8. Alam MB, Munir MB, Rattan R, Adelstein E, Jain S, Saba S. Battery longevity from cardiac resynchronization therapy defibrillators: differences between manufacturers and discrepancies with published product performance reports. Europace 016;doi:10.1093/europace/euw044. First published online: 22-MAR-2016. Kaplan Meier curves depicting survival of CRT devices free from battery depletion by device manufacturer. Battery Longevity in Cardiac Medtronic = 416 patients, Boston Scientific = 173 patients, St. Jude Medical = 57patients. Previously evaluated these patients at a four-year survival rate calculated using device replacements for battery depletion as indicated by ERI. 2014; Europace (2014) 16,246-51.
9. Shabanna Din, Shabanna, Mcgee, Rao, Archana, Wright, Jay D. Longevity of implantable cardioverter defibrillators: The impact of device manufacturer and device type on device longevity were assessed. Europace. 2015 Nov 25; . Epub 2015 Nov 25. Total patients = 3436. Cardiostim Abstract 2016. Total patients = 1489.
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References
Reference #4Boehmer et al. A Multisensor Algorithm Predicts Heart Failure Events in Patients With Implanted Devices. Results from the MultiSENSE Study. JACC: Heart Failure. Volume 5 Issue 3. March 1, 2017
Reference #5Based on approximate mapping speed of 95 pts / minute in the right atrium in 5 swine USING THE ST. JUDE PRECISION ENSITE MAPPING SYSTEM. Ptaszek LM, et al. “Rapid High-Density Automated Electroanatomical Mapping Using Multiple Catheter Types.” Poster Session PO097 APHRS 2015.Based on approximate mapping speed of 491 pts / minute in the right atrium in 5 swine USING THE BOSTON SCIENTIFIC RHYTHMIA MAPPING & NAVIGATION SYSTEM. Ptaszek LM, et al. “Rapid Acquisition of High-Resolution Electroanatomical Maps Using a Novel Multielectrode Mapping System.” JICE. Nov 2012.C1. Ptaszek L, Chalhoub F, Perna F, Beinart R, Barrett C, Danik S, Heist EK, Ruskin J, Mansour M, Rapid Acquisition of High-Resolution Electroanatomical Mapping Using a Novel Multi-Electrode Mapping System. J Interv Card Electrophysiol. 2012 Nov 22
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Rhythm Management Offers a Broad Portfolio of Innovative Products and Solutions in Large Markets
Clinical Evidence
Patient Management
Diagnostics & Monitoring Cardiac Rhythm Management
Modular CRM Systems
Mapping & AblationLeft Atrial Appendage Closure