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Battery Technology in
Defibrillators
Improvement in ICD technology after 2009
• Efficiency
• Size
• Battery Capacity
Study Implant Dates
Knops (PACE 2009)
Schaer (Heart Rhythm 2009)
Biffi (Europace 2008)
Kallinen (ESC 2009)
Horlbeck (Heart Rhythm 2012)
Thijssen (JCE 2012)
Shafat (Clin Res Cardiol 2012)
Saba (Europace 2016)
Johansen (HRS 2014)
Ellis (PACE 2016)
Williams (HFSA 2014)
Landolina (Europace 2015)
Lau (HRS 2015)
Schaer / von Gunten (Europace 2015)
1998 2002 2006 2010 2014
1994
1990
1986
Longevity studies before and after ENDURALIFE battery technology
Independent Studies
Advanced manufacturing capabilities enable a device that is smaller and higher battery usable capacity
Efficiency
References in notes
Is there really a need for longer-lasting devices?
Patients today are living longer than their device.1,2
Patients getting devices earlier, living longer and need longer lasting devices.7
ZERO
A longer lasting device
means no replacements for
higher number of
patients7,8
75%
CRT-D change-outs
avoidable for patients >70
years by using a CRT-D with
9 year longevity6
50%
ICD change-outs avoidable
for patients <50 years by
using an ICD with 12 year
longevity6
90%
Patients desire a longer
lasting device9
35-45%
Patients with an ICD or CRT-
D that are <65 years of age3
>80%
Mildly symptomatic HF CRT-
D patient survival at 7
years4
>40%
ICD patients living
after 10 years1
3%
Annual mortality rate for
CRT-D patients with
moderate heart failure5
1Hauser. The growing mismatch between patient longevity and the service life of implantable cardioverter-defibrillators. JACC 2005; 45; 2022-5.2Swedish ICD and Pacemaker Register: Annual Statistical Report
2011. https://www.pacemakerregistret.se/icdpmr/. 3Novation - Cardiovascular Watch: CRM Device Battery Life, May 2012 - https://www.novationco.com/other/apps/devicebattery/ 4Goldenberg I, Kutyifa V,
Klein H, et. al. Survival with Cardiac-Resynchronization Therapy in Mild Heart Failure. NEJM 370;18: 1694-1701. Seven year survival relates to patients with left bundle branch block with QRS ≥ 130 ms, EF ≤
30% NYHA Class I or II ischemic or NYHA Class II non-ischemic heart failure. 5Moss AJ, Cannom DS, Brown MW, et al. Cardiac-Resynchronization Therapy for the Prevention of Heart Failure Events. NEJM. Sept
2009 ePublication. 6Lau E, Hammill E, Wold N. Projected Numbers of Replacements Required During Natural Lifespan of CRTD/ICD Recipients by Age at First Implantation for Different Device Longevities.
Presented at HRS 2015. n= 115,000 CRTDs, 300,000 ICDs. 7Ramachandra. Impact of ICD Battery Longevity on Need for Device Replacements. PACE 2010; 33:314–319. 8Borleffs CJ, Thijssen J, Mihaly K, van Rees
JB, van Erven L, et al. Recurrent Implantable Cardioverter-Defibrillator Replacement is Associated with an Increasing Risk of Pocket-Related Complications. PACE 2010;33:1013–1019. 9Wild DM, Fisher JD, Kim
SG, Ferrick KJ, Gross JN, Palma EC. Pacemakers and Implantable Cardioverter Defibrillators: Device Longevity Is More Important Than Smaller Size: The Patient’s Viewpoint. Pace Nov 2004; Vol. 27:1526-1529.
2014 Ellis Study confirmed that battery capacity (a.k.a., Ampere Hours) is a predictor
of longevity.
Ampere Hour (Ah) as a Predictor of CRT-ICD
Pulse Generator Battery Longevity was a multi-
center, retrospective, observational study
comparing battery longevity of contemporary
cardiac resynchronization therapy defibrillators
(CRT-Ds) of all patients implanted with
CRT-ICDs from Aug. 1, 2008, to Dec. 31, 2010, at
5 major institutions.4
Boston Scientific = 322 patients
Medtronic = 794 patients
St. Jude Medical = 186 patients
*Survival rate calculated using device replacements for battery depletion as indicated by ERI.
Battery Capacity Study
References in notes
2015 Landolina study confirmed that ENDURALIFE battery technology delivers the most
dramatic improvement in device longevity compared to previous generations.5
Technology Platform Comparison Study
Boston Scientific = 608 patients
Medtronic = 798 patients
St. Jude Medical = 172 patients
Biotronik = 49 patients
Sorin = 99 patients
References in notes
NICE recommendations for EnduraLife Batteries
UK’s National Institute for Health and Care Excellence…
providing evidenced-based guidance to improve health and
social care in the National Health Service (NHS).
1.MTG 294. NICE medical technology guidance: ENDURALIFE-powered CRT-D devices for treating heart failure. March 2017. NICE is sponsored by the British Department of Health
Context for Recommendation
submitted clinical evidence and economic data to support our EnduraLife-powered CRT-
Ds…
Recommendation
Published March 2017
9 Independent CRT-D Survival Trials
Over 11,314 patients show that EnduraLife-powered Boston Scientific CRT-Ds are lasting
longer than comparable devices from other manufacturers
9 studies reported industry leading longevity for our CRT-Ds powered by EnduraLife. Refer to full references on the last slide.
2015
Johansen
Study1
2014
Williams
Study2
2016
Ellis
Study3
2015
Landolina
Study4
2015
Zanon
Study5
2015
Lau
Study6
2015
Schaer/Von Gunten
Study7
2016
Saba
Study8
2016
Din/Wright
Study9
CRT-D
4-year
Survival
N=2742
CRT-D
4-year
Survival
N=91
CRT-D
5-year
Survival Probability
N=1302
CRT-D
5-year
Survival
N=1081
CRT-D
5-year
Survival
N=433
CRT-D
6-year
Survival
N=155
CRT-D
6-year
Survival
N=3436
CRT-D
6-year
Survival
N=646
CRT-D
7-year
Survival
N=1489
4 years 5 years 6 years 7 years
Boston Scientific
St. Jude Medical
Medtronic
Resonate Family Longevity Projections
The latest generation of EnduraLife batteries feature the industry’s longest battery life
projections
1 Assumes: 2.0V RA, 2.0V RV, 0% pacing, 700Ω, No LATITUDE, No
Respiratory Rate Sensor, No Heart Failure Sensor Suite.
2 Assumes: 2.0V RA, LV-only, 2.0V LV, 700Ω, 15% A pacing, 100% LV
pacing, No LATITUDE, No Respiratory Rate Sensor, No Heart Failure
Sensor Suite.
Projected Longevities for
RESONATE and Vigilant Devices
VR ICD Up to 17.5 years1
DR ICD Up to 16.0 years1
CRT-D Up to 14.7 years2
EnduraLife™ Battery Technology provides you with clinical freedom to make programming
decisions without worrying about the battery.

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ICD TECH CSI JPR.pptx

  • 2. Improvement in ICD technology after 2009 • Efficiency • Size • Battery Capacity
  • 3. Study Implant Dates Knops (PACE 2009) Schaer (Heart Rhythm 2009) Biffi (Europace 2008) Kallinen (ESC 2009) Horlbeck (Heart Rhythm 2012) Thijssen (JCE 2012) Shafat (Clin Res Cardiol 2012) Saba (Europace 2016) Johansen (HRS 2014) Ellis (PACE 2016) Williams (HFSA 2014) Landolina (Europace 2015) Lau (HRS 2015) Schaer / von Gunten (Europace 2015) 1998 2002 2006 2010 2014 1994 1990 1986 Longevity studies before and after ENDURALIFE battery technology Independent Studies
  • 4. Advanced manufacturing capabilities enable a device that is smaller and higher battery usable capacity Efficiency References in notes
  • 5. Is there really a need for longer-lasting devices? Patients today are living longer than their device.1,2 Patients getting devices earlier, living longer and need longer lasting devices.7 ZERO A longer lasting device means no replacements for higher number of patients7,8 75% CRT-D change-outs avoidable for patients >70 years by using a CRT-D with 9 year longevity6 50% ICD change-outs avoidable for patients <50 years by using an ICD with 12 year longevity6 90% Patients desire a longer lasting device9 35-45% Patients with an ICD or CRT- D that are <65 years of age3 >80% Mildly symptomatic HF CRT- D patient survival at 7 years4 >40% ICD patients living after 10 years1 3% Annual mortality rate for CRT-D patients with moderate heart failure5 1Hauser. The growing mismatch between patient longevity and the service life of implantable cardioverter-defibrillators. JACC 2005; 45; 2022-5.2Swedish ICD and Pacemaker Register: Annual Statistical Report 2011. https://www.pacemakerregistret.se/icdpmr/. 3Novation - Cardiovascular Watch: CRM Device Battery Life, May 2012 - https://www.novationco.com/other/apps/devicebattery/ 4Goldenberg I, Kutyifa V, Klein H, et. al. Survival with Cardiac-Resynchronization Therapy in Mild Heart Failure. NEJM 370;18: 1694-1701. Seven year survival relates to patients with left bundle branch block with QRS ≥ 130 ms, EF ≤ 30% NYHA Class I or II ischemic or NYHA Class II non-ischemic heart failure. 5Moss AJ, Cannom DS, Brown MW, et al. Cardiac-Resynchronization Therapy for the Prevention of Heart Failure Events. NEJM. Sept 2009 ePublication. 6Lau E, Hammill E, Wold N. Projected Numbers of Replacements Required During Natural Lifespan of CRTD/ICD Recipients by Age at First Implantation for Different Device Longevities. Presented at HRS 2015. n= 115,000 CRTDs, 300,000 ICDs. 7Ramachandra. Impact of ICD Battery Longevity on Need for Device Replacements. PACE 2010; 33:314–319. 8Borleffs CJ, Thijssen J, Mihaly K, van Rees JB, van Erven L, et al. Recurrent Implantable Cardioverter-Defibrillator Replacement is Associated with an Increasing Risk of Pocket-Related Complications. PACE 2010;33:1013–1019. 9Wild DM, Fisher JD, Kim SG, Ferrick KJ, Gross JN, Palma EC. Pacemakers and Implantable Cardioverter Defibrillators: Device Longevity Is More Important Than Smaller Size: The Patient’s Viewpoint. Pace Nov 2004; Vol. 27:1526-1529.
  • 6. 2014 Ellis Study confirmed that battery capacity (a.k.a., Ampere Hours) is a predictor of longevity. Ampere Hour (Ah) as a Predictor of CRT-ICD Pulse Generator Battery Longevity was a multi- center, retrospective, observational study comparing battery longevity of contemporary cardiac resynchronization therapy defibrillators (CRT-Ds) of all patients implanted with CRT-ICDs from Aug. 1, 2008, to Dec. 31, 2010, at 5 major institutions.4 Boston Scientific = 322 patients Medtronic = 794 patients St. Jude Medical = 186 patients *Survival rate calculated using device replacements for battery depletion as indicated by ERI. Battery Capacity Study References in notes
  • 7. 2015 Landolina study confirmed that ENDURALIFE battery technology delivers the most dramatic improvement in device longevity compared to previous generations.5 Technology Platform Comparison Study Boston Scientific = 608 patients Medtronic = 798 patients St. Jude Medical = 172 patients Biotronik = 49 patients Sorin = 99 patients References in notes
  • 8. NICE recommendations for EnduraLife Batteries UK’s National Institute for Health and Care Excellence… providing evidenced-based guidance to improve health and social care in the National Health Service (NHS). 1.MTG 294. NICE medical technology guidance: ENDURALIFE-powered CRT-D devices for treating heart failure. March 2017. NICE is sponsored by the British Department of Health
  • 9. Context for Recommendation submitted clinical evidence and economic data to support our EnduraLife-powered CRT- Ds…
  • 11. 9 Independent CRT-D Survival Trials Over 11,314 patients show that EnduraLife-powered Boston Scientific CRT-Ds are lasting longer than comparable devices from other manufacturers 9 studies reported industry leading longevity for our CRT-Ds powered by EnduraLife. Refer to full references on the last slide. 2015 Johansen Study1 2014 Williams Study2 2016 Ellis Study3 2015 Landolina Study4 2015 Zanon Study5 2015 Lau Study6 2015 Schaer/Von Gunten Study7 2016 Saba Study8 2016 Din/Wright Study9 CRT-D 4-year Survival N=2742 CRT-D 4-year Survival N=91 CRT-D 5-year Survival Probability N=1302 CRT-D 5-year Survival N=1081 CRT-D 5-year Survival N=433 CRT-D 6-year Survival N=155 CRT-D 6-year Survival N=3436 CRT-D 6-year Survival N=646 CRT-D 7-year Survival N=1489 4 years 5 years 6 years 7 years Boston Scientific St. Jude Medical Medtronic
  • 12. Resonate Family Longevity Projections The latest generation of EnduraLife batteries feature the industry’s longest battery life projections 1 Assumes: 2.0V RA, 2.0V RV, 0% pacing, 700Ω, No LATITUDE, No Respiratory Rate Sensor, No Heart Failure Sensor Suite. 2 Assumes: 2.0V RA, LV-only, 2.0V LV, 700Ω, 15% A pacing, 100% LV pacing, No LATITUDE, No Respiratory Rate Sensor, No Heart Failure Sensor Suite. Projected Longevities for RESONATE and Vigilant Devices VR ICD Up to 17.5 years1 DR ICD Up to 16.0 years1 CRT-D Up to 14.7 years2 EnduraLife™ Battery Technology provides you with clinical freedom to make programming decisions without worrying about the battery.

Editor's Notes

  1. Data on file at Boston Scientific Corporation.
  2. Ellis CR, Dickerman DI, Orton JM, Hassan S, Good ED, Okabe T, Andriulli JA, Quan KJ, Greenspon AJ. Ampere Hour as a Predictor of Cardiac Resynchronization Defibrillator Pulse Generator Battery Longevity: A Multicenter Study. PACE 2016;39:658-668.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.
  3. 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.