Cardiac Assist Devices US Analysis and Market Forecasts
GDME1024CFR / Published March 2013
Executive Summary
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Cardiac Assist Devices: Key Metrics in US Device Markets Congestive Heart Failure Prevalence, 2012 6.1m
New Incidents per Year, 2012 0.8m
End-Stage Congestive Heart Failure Prevalence, 2012 0.3m
US Cardiac Assist Device Market Revenue, 2012
US $758m
US Market Revenue by Device Type, 2012
Intra-Aortic Balloon Pumps $139m
Total Artificial Hearts $20m
Ventricular Assist Device Global Revenue $598m
Extracorporeal Ventricular Assist Devices 5
Intracorporeal Ventricular Assist Devices 5
Total Artificial Hearts 2
Global Events Affecting the CAD Market (2012–2019)
Level of Impact
Approval of DuraHeart (Terumo) by US FDA ↑
Approval of EvaHeart (Sun Medical) by USA FDA ↑
Approval of HeartAssist 5 (MicroMed Cardio) by US FDA ↑↑
Approval of Synergy (Circulite) by US FDA ↑↑
Approval of C-Pulse (Sunshine Heart) by US FDA ↑
Forecast US Revenue by Device Type, 2019
Intra-Aortic Balloon Pumps $156m
Ventricular Assist Devices $1,526m
Total Artificial Hearts $68m
Total $1,750m
Source: GlobalData
The Cardiac Assist Device Market is Expected to Experience Significant Growth Through 2019
The Cardiac Assist Device (CAD) market, including Intra-
Aortic Balloon Pumps (IABP), Ventricular Assist Devices
(VAD), and Total Artificial Hearts (TAH), is expected to
experience significant growth during the seven-year
forecast period. GlobalData estimates the US market in
2012 for IABP, VAD and TAH to be $139m, $598m, and
$20m respectively. All together, the Cardiac Assist
Device Market is expected to grow at a Compound
Annual Growth Rate (CAGR) of 12.7% to surpass $1.7
billion by 2019.
The World Health Organization estimates that
approximately 800,000 incident cases of Congestive
Heart Failure occur each year in the US. The prevalence
of CHF in the western world, where it is highest, ranges
from 1%–2% and the incidence of CHF approaches 5.1
cases per 1,000 person-years.
Key Drivers during the Forecast Period:
Growing congestive heart failure population and
shortages of donor hearts for transplantation
Extensive clinical studies and device miniaturizations
leading to increased adoption
Growing patient awareness and rising numbers of
heart centers
Key Barriers during the Forecast Period:
High costs make treatment unaffordable
Complications associated with use still prevalent
Long R&D time deters new entrants from market
Executive Summary
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Companies Working to Get Their Devices Approved in the CAD Market
The most significant driver of CAD development is the
lack of suitable options for an increasingly large elderly
CHF population; heart transplants per annum have been
steady for decades, but the population with heart failure
continues to grow. Additionally, as device safety
improves, physicians will look to implant devices in less-
sick patients, including NYHA Class IIIB and III patients,
which will only further expand the potential CAD market.
The most prohibitive factor to widespread CAD adoption
has been the high cost of the devices, as well as
complications associated with long-term use. As device
prices fall and rates of complication decrease, the CAD
market will experience significant growth.
Significant Growth in Target Population
Incidence of other diseases that cause heart failure is
also growing, including hypertension, diabetes, obesity,
and coronary artery disease. According to the World
Health Organization, in 2010, globally over 600 million
people suffered from hypertension, which is a major
cause of heart failure. According to the International
Diabetes Federation, an estimated 285 million people
had diabetes in 2010, which is predicted to increase to
438 million people by 2030. Similarly the population for
obesity is also increasing at a rapid rate. Lifestyle factors
such as smoking and alcohol intake can also greatly
increase the risk of CHF. CADs are expected to be a
viable option for CHF even in patients with less-advanced
but progressive heart failure.
Extensive Clinical Studies to Increase Adoption
In recent years, there has been increased emphasis on
conducting clinical trials with larger patient cohorts in
order to provide sufficient evidence to convince
physicians and patients of the benefits of CAD, especially
for long-term use. As clinical experience with CAD
amasses, reimbursement improvements and physician
adoption will drive significant device sales around the
world.
In coming years, large populations of CHF patients will
require heart transplantation, but donor availability will
lead to a shortage of transplants to treat these patients.
With no other options, these patients will turn to CAD to
aid or replace their failing heart.
People today are increasingly aware of CHF and
treatment options available, especially in developed
countries, which has led to an increased use of
diagnostic procedures and available treatment options for
end-stage heart failure. Heightened patient awareness in
regards to the progressive and fatal nature of CHF has
also resulted in increased patient spending to treat the
condition. With a rise in accessibility to healthcare,
combined with a growing population of insured patients,
the CAD market will experience growth in both developed
and undeveloped global markets.
Older and Younger Patients to Be Treated In the Future
It is expected that in the coming years, physicians will
have more options for treating both elderly patients and
pediatrics. Especially for young patients, the waiting time
for a heart transplant can be quite long, and CAD
technology offers an alternative to inotropic support
during the Bridge-To-Transplantation phase. As CADs
become cheaper and easier to use, the adoption of these
devices will surge.
Executive Summary
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Remaining Opportunities for New Entrants
Physicians around the world believe that Transcutaneous
Energy Transfer (TET) technology will be the next big
advancement for CAD, and a way for companies to
differentiate their product from competitors. The concept
of TET has existed for quite some time; however, no
devices have perfected the technology. While newer
iterations of VAD and TAH address many problems with
coagulation, size and efficacy, issues with driveline
infection have been largely ignored since the
technology’s inception. In fact, the rate of driveline
infection is as low as it has ever been, although good
practices cannot fully eliminate this drawback. Only with
fully implantable devices will the risk of infection drop.
Reductions of Rehospitalization Rates
CHF has the highest readmission rate of any diagnostic-
related group, and since the Affordable Care Act’s
Hospital Readmission Reduction Program incentivizes
hospitals to ensure their CHF-related rehospitalization
rates meet a defined benchmark, hospitals will be eager
to adopt CAD technology that can reduce rates of
rehospitalization. This provides an enormous market
opportunity for CAD products with low rates of
rehospitalization. As such, there is enormous pressure on
CAD companies to meet these newly-established high
standards. It is expected that in addition to product
advancements, there will be a noticeable reduction in
rehospitalization rates as new guidelines for patient
selection are developed. Doctors are hopeful that
rehospitalization rates will eventually decrease as a result
of procedural improvements, better patient selection, and
reductions in device failure rates.
CAD Implantation in Less-Sick Patients
The current treatment paradigm for CHF patients is
limited to NYHA Class IV patients; few approved options
exist that are approved for Class III patients besides
optimal medical management. As companies look to
expand their target market by treating younger and
healthier patient cohorts, their devices will need to
receive FDA approval for lower NYHA classes. Current
trial data does not justify VAD implantation into Class III
patients; published survival with a VAD is inferior to the
survival expected with medical therapy for Class III CHF.
However, for patients not facing imminent death, the
functional benefits of CAD implantation could provide
more compelling indications than survival alone.
What do Physicians Think?
Adoption is on the rise around the world:
“I’m convinced that we will use many more cardiac assist
devices than now; it will rise dramatically.”
OUS Key Opinion Leader, January 2013
Quality of life improvements are increasing cost
effectiveness:
“Everyone’s always complaining about the fact that these
implantable devices are too expensive. And they are
expensive, without a doubt. That makes it a little more
difficult for physicians to really include all kinds of
patients. However, if quality of life is increasing, cost
effectiveness will as well. Even with the high costs of the
devices these days [which will stay high], cost
effectiveness will be coming down in future years.”
OUS Key Opinion Leader, January 2013
Executive Summary
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TAH and VAD develop separate target populations:
“The problem and concern with TAH is that the procedure
is not recoverable; the native heart is removed. Once you
put in a TAH, you must go forward with the
transplantation. With VAD [support], there is the hope
that the patient could recover and improve their
condition.”
OUS Key Opinion Leader, January 2013
Expanding indications will drive future device sales:
“In the future, we will see older patients, more permanent
devices, also younger patients who are not eligible for
high urgency status on the transplant list will receive
devices. Put an assist device in the patient, and wait, and
then if the patient stabilizes and is good, you can
transplant them.”
OUS Key Opinion Leader, January 2013
Developing nations are looking to use CAD, too:
“If CAD costs were to decrease to the point where they
could be used in India and other developing countries,
and companies could still make a profit, there is a lot of
opportunity. This is especially true if [a company] is
interested in developing a product in the country […] if a
company wants to do business with a country of large
scale, the numbers game, then this is the place.”
OUS Key Opinion Leader, February 2013
Heart transplantation is increasingly not a suitable
option:
“Heart transplantation is becoming increasingly obsolete,
and assist devices are more and more [efficient].”
OUS Key Opinion Leader, January 2013
Table of Contents
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1 Table of Contents
1 Table of Contents ............................................................................................................... 6
1.1 List of Tables ............................................................................................................. 13
1.2 List of Figures ........................................................................................................... 19
2 Introduction ....................................................................................................................... 20
2.1 Catalyst ..................................................................................................................... 20
3 Disease Overview – Congestive Heart Failure................................................................... 22
3.1 Anatomy and Physiology ........................................................................................... 22
3.2 Pathophysiology ........................................................................................................ 22
3.3 Types of Heart Failure ............................................................................................... 23
3.3.1 Classification by Progression .............................................................................. 23
3.3.2 Classification by Location .................................................................................... 24
3.3.3 Classification by Pumping Mechanism................................................................. 24
3.4 Etiology ..................................................................................................................... 25
3.4.1 Conditions That Cause Heart Failure ................................................................... 25
3.4.2 Other Risk Factors .............................................................................................. 26
3.5 Clinical Presentation .................................................................................................. 30
3.5.1 Symptoms of Heart Failure .................................................................................. 30
3.6 Diagnosis of Heart Failure ......................................................................................... 31
3.6.1 Stages of Heart Failure Based on Diagnosis ....................................................... 33
3.7 Epidemiology ............................................................................................................ 35
3.7.1 US ...................................................................................................................... 35
3.8 Epidemiology Forecast (2012–2019) ......................................................................... 36
3.8.1 Prevalent Cases of Congestive Heart Failure ...................................................... 36
3.9 Clinical Outcomes ..................................................................................................... 36
3.9.1 Prognosis ............................................................................................................ 36
3.9.2 Surgical Risk Stratification ................................................................................... 37
3.10 Treatment Modalities ................................................................................................. 38
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3.10.1 Medication .......................................................................................................... 39
3.10.2 Surgery ............................................................................................................... 39
3.10.3 Cardiac Assistance ............................................................................................. 40
3.10.4 Heart Transplantation .......................................................................................... 43
3.11 Economic Impact ....................................................................................................... 44
3.11.1 Individual Costs................................................................................................... 44
3.11.2 Industry Costs ..................................................................................................... 45
4 Competitive Assessment ................................................................................................... 46
4.1 Cardiac Assist Device Market, Comparison of Key Marketed Products ...................... 46
4.2 Ventricular Assist Devices, Comparison based on Pump Technology ........................ 49
4.3 Ventricular Assist Devices ......................................................................................... 50
4.3.1 Overview............................................................................................................. 50
4.3.2 First-Generation Devices ..................................................................................... 51
4.3.3 Second-Generation Devices ................................................................................ 52
4.3.4 Third-Generation Devices ................................................................................... 52
4.3.5 Fourth-Generation Devices ................................................................................. 53
4.3.6 Fifth-Generation Devices ..................................................................................... 53
4.3.7 Sixth-Generation Devices .................................................................................... 53
4.3.8 Seventh-Generation Devices ............................................................................... 53
4.3.9 Counterpulsation Devices ................................................................................... 53
4.3.10 Adult Primary Implant Breakdown........................................................................ 54
4.3.11 Brand-Specific Training ....................................................................................... 54
4.4 Extracorporeal Ventricular Assist Devices .................................................................. 55
4.4.1 AB5000 (Abiomed, Inc.) ...................................................................................... 55
4.4.2 CentriMag, PediMag (Thoratec) .......................................................................... 57
4.4.3 Delta-Stream DP3 Pump (Medos Medizintechnik AG) ......................................... 60
4.4.4 Excor (Berlin Heart)............................................................................................. 61
4.4.5 PVAD (Thoratec) ................................................................................................. 63
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4.4.6 RotaFlow (Maquet Cardiovascular) ..................................................................... 65
4.5 Intracorporeal Ventricular Assist Devices ................................................................... 67
4.5.1 DuraHeart (Terumo) ............................................................................................ 68
4.5.2 EvaHeart (Sun Medical Technology Research Corporation) ................................ 70
4.5.3 Heart Assist 5 (MicroMed Cardiovascular, Inc.) ................................................... 72
4.5.4 HeartMate II (Thoratec) ....................................................................................... 74
4.5.5 HVAD (HeartWare) ............................................................................................. 78
4.5.6 Incor (Berlin Heart) .............................................................................................. 82
4.5.7 IVAD (Thoratec) .................................................................................................. 84
4.5.8 Jarvik 2000 (Jarvik Heart) ................................................................................... 86
4.6 Percutaneous Ventricular Assist Devices ................................................................... 89
4.6.1 Impella (Abiomed, Inc.) ....................................................................................... 90
4.6.2 Synergy (CircuLite) ............................................................................................. 93
4.6.3 TandemHeart (Cardiac Assist, Inc.) ..................................................................... 95
4.7 Intra-Aortic Balloon Pumps ........................................................................................ 98
4.7.1 Overview............................................................................................................. 98
4.7.2 AutoCAT 2 Wave (Teleflex) ............................................................................... 100
4.7.3 CardioSave (Maquet Cardiovascular) ................................................................ 102
4.7.4 CS300 (Maquet Cardiovascular) ....................................................................... 104
4.7.5 iVAC (PulseCath) .............................................................................................. 106
4.7.6 Xemex (Zeon) ................................................................................................... 107
4.8 Extra-Aortic Balloon Pumps ..................................................................................... 108
4.8.1 C-Pulse (Sunshine Heart) ................................................................................. 110
4.9 Total Artificial Heart ................................................................................................. 114
4.9.1 Overview........................................................................................................... 114
4.9.2 AbioCor (Abiomed)............................................................................................ 115
4.9.3 SynCardia (SynCardia Systems, Inc.)................................................................ 117
4.10 Extracorporeal Membrane Oxygenation ................................................................... 119
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5 Unmet Needs and Opportunities ..................................................................................... 120
5.1 Unmet Needs .......................................................................................................... 121
5.1.1 Transcutaneous Energy Transfer to Reduce Risk of Infection and Improve
Lifestyle ........................................................................................................... 121
5.1.2 Anti-Coagulation to Reduce Risk of Stroke ........................................................ 123
5.1.3 Thromboresistant Coatings ............................................................................... 123
5.1.4 Noncontact Bearing Design ............................................................................... 124
5.2 Opportunities ........................................................................................................... 125
5.2.1 Reduction of Rehospitalization Rates ................................................................ 125
5.2.2 NYHA Class III Patients .................................................................................... 127
5.2.3 Destination Therapy .......................................................................................... 128
5.2.4 Pediatrics .......................................................................................................... 130
5.2.5 Hybrid Combination Therapy ............................................................................. 131
5.2.6 Mitral Valve Repair ............................................................................................ 132
6 Pipeline Products ............................................................................................................ 133
6.1 Overview ................................................................................................................. 133
6.2 Ventricular Assist Devices ....................................................................................... 134
6.2.1 CorAide, DexAide (Teleflex) .............................................................................. 134
6.2.2 DuraHeart II (Terumo) ....................................................................................... 136
6.2.3 HeartMate III (Thoratec) .................................................................................... 137
6.2.4 HeartMate X (Thoratec)..................................................................................... 138
6.2.5 MiFlow (HeartWare) .......................................................................................... 139
6.2.6 MiTiHeart LVAD (Mohawk Innovative Technology, Inc.)..................................... 140
6.2.7 MVAD (HeartWare) ........................................................................................... 142
6.2.8 PediaFlow VAD (HeartWare) ............................................................................. 144
6.2.9 PediPump (Cleveland Clinic) ............................................................................. 145
6.2.10 Revolution (Vadovations, Inc.) ........................................................................... 146
6.2.11 s.pump (Medos Medizintechnik AG) .................................................................. 147
6.3 Percutaneous Ventricular Assist Devices ................................................................. 148
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6.3.1 HeartMate PHP (Thoratec) ................................................................................ 148
6.3.2 Reitan Catheter Pump (CardioBridge GmbH) .................................................... 149
6.4 Total Artificial Hearts ............................................................................................... 151
6.4.1 AbioCor II (Abiomed, Inc.) ................................................................................. 151
6.4.2 Carmat TAH (Carmat) ....................................................................................... 152
6.4.3 Golding TAH (Cleveland Clinic) ......................................................................... 154
6.4.4 Beatless Heart (Texas Heart Institute) ............................................................... 155
6.4.5 MagScrew (Cleveland Clinic) ............................................................................ 157
6.4.6 ReinHeart (University of Aachen) ...................................................................... 158
6.4.7 Other ................................................................................................................ 158
7 Current and Future Players ............................................................................................. 159
7.1 Company Profiles .................................................................................................... 159
7.1.1 Abiomed, Inc. .................................................................................................... 159
7.1.2 Berlin Heart ....................................................................................................... 161
7.1.3 CardiacAssist, Inc. ............................................................................................ 163
7.1.4 CardioBridge ..................................................................................................... 164
7.1.5 Carmat .............................................................................................................. 165
7.1.6 CircuLite ........................................................................................................... 166
7.1.7 HeartWare International, Inc. ............................................................................. 167
7.1.8 Jarvik Heart....................................................................................................... 170
7.1.9 Maquet Cardiovascular ..................................................................................... 172
7.1.10 Medos Medizintechnik AG ................................................................................. 173
7.1.11 MicroMed Cardiovascular, Inc. .......................................................................... 174
7.1.12 MiTiHeart Corporation ....................................................................................... 176
7.1.13 PulseCath BV ................................................................................................... 177
7.1.14 Sunshine Heart ................................................................................................. 178
7.1.15 SynCardia Systems, Inc. ................................................................................... 180
7.1.16 Teleflex Medical ................................................................................................ 182
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7.1.17 Terumo ............................................................................................................. 183
7.1.18 Thoratec ........................................................................................................... 185
7.1.19 Sun Medical ...................................................................................................... 190
7.1.20 Zeon Medical .................................................................................................... 191
7.1.21 Other ................................................................................................................ 191
8 Market Drivers, Opportunities, and Barriers ..................................................................... 192
8.1 Market Drivers ......................................................................................................... 193
8.1.1 Increasing Heart Failure Population ................................................................... 193
8.1.2 Technological Advancements, Miniaturizations, Leading to Increased Adoption
by Physicians................................................................................................... 194
8.1.3 Extensive Clinical Studies to Improve Adoption ................................................. 194
8.1.4 Growing Patient Awareness and Increasing Numbers of Heart Centers ............. 195
8.1.5 Aging Population to Drive Growth in Cardiac Assist Devices Market .................. 196
8.2 Market Opportunities ............................................................................................... 198
8.2.1 Highly Under-Penetrated Market to Provide Significant Opportunity ................... 198
8.2.2 Shortage of Donor Hearts for Transplantation Creates Opportunity.................... 198
8.3 Market Barriers........................................................................................................ 199
8.3.1 Complications Associated with CAD .................................................................. 199
8.3.2 High Cost Makes Treatment Unaffordable ......................................................... 199
8.3.3 Alternative Therapies ........................................................................................ 200
8.3.4 Medical Device Tax Affects Manufacturers ........................................................ 200
8.3.5 Long Research and Development of Devices may Deter New Entrants into the
Market ............................................................................................................. 201
8.3.6 Complications Associated with Cardiac Assist Devices might Deter Physicians
from Adoption of Their Use .............................................................................. 201
8.4 Mergers and Acquisitions ........................................................................................ 201
8.4.1 Potential Sunshine Acquisition .......................................................................... 201
9 Country Outlook and Forecasts ....................................................................................... 202
9.1 US ......................................................................................................................... 202
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9.1.1 Overview........................................................................................................... 202
9.1.2 Reimbursement................................................................................................. 203
9.1.3 Affordable Care Act Rehospitalization Fees ....................................................... 203
9.1.4 US CAD Market Revenue, 2010–2019 .............................................................. 204
10 Appendix ........................................................................................................................ 206
10.1 Abbreviations .......................................................................................................... 206
10.2 Bibliography ............................................................................................................ 208
10.3 Methodology ........................................................................................................... 222
10.3.1 Forecasting ....................................................................................................... 222
10.3.2 Sources Used ................................................................................................... 222
10.3.3 Forecast Assumptions and Methods .................................................................. 223
10.4 Coverage ................................................................................................................ 225
10.5 Secondary Research ............................................................................................... 225
10.6 Forecasting Methodology ........................................................................................ 226
10.6.1 Pricing Assumptions .......................................................................................... 226
10.7 Physicians and Specialists Included in this Study .................................................... 227
10.8 Primary Research.................................................................................................... 228
10.9 About the Authors ................................................................................................... 229
10.9.1 Analysts ............................................................................................................ 229
10.9.2 Global Head of Healthcare ................................................................................ 230
10.10 Definitions ......................................................................................................... 231
10.11 About GlobalData .............................................................................................. 232
10.12 Contact Us ........................................................................................................ 232
10.13 Disclaimer ......................................................................................................... 232
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1.1 List of Tables
Table 1: New York Heart Association Scale ...................................................................... 34
Table 2: American College of Cardiology Scale................................................................. 34
Table 3: Prevalent Cases of Congestive Heart Failure, All Markets, Ages ≥45 Years, Men
and Women (n), 2012–2019 ................................................................................ 36
Table 4: Device Strategy at Time of Implant in US, 2011 ................................................... 41
Table 5: Cardiac Assist Devices by Launch....................................................................... 46
Table 6: Cardiac Assist Devices by Type .......................................................................... 49
Table 7: Product Profile – AB5000 .................................................................................... 55
Table 8: AB5000 SWOT Analysis, 2012 ............................................................................ 56
Table 9: Product Profile – CentriMag, PediMag ................................................................. 58
Table 10: CentriMag, PediMag SWOT Analysis, 2012 ........................................................ 59
Table 11: Product Profile – Delta-Stream DP3 Pump .......................................................... 60
Table 12: Delta-Stream DP3 SWOT Analysis, 2012 ............................................................ 60
Table 13: Product Profile – Excor........................................................................................ 61
Table 14: Excor SWOT Analysis, 2012 ............................................................................... 62
Table 15: Product Profile – PVAD ....................................................................................... 63
Table 16: PVAD SWOT Analysis, 2012 ............................................................................... 64
Table 17: Product Profile – RotaFlow .................................................................................. 65
Table 18: RotaFlow SWOT Analysis, 2012 ......................................................................... 66
Table 19: Product Profile – DuraHeart ................................................................................ 68
Table 20: DuraHeart SWOT Analysis, 2012 ........................................................................ 69
Table 21: Product Profile – EvaHeart .................................................................................. 70
Table 22: EvaHeart SWOT Analysis, 2012 .......................................................................... 71
Table 23: EvaHeart US Pivotal BTT Trial ............................................................................ 71
Table 24: Product Profile – HeartAssist 5 ............................................................................ 73
Table 25: HeartAssist 5 SWOT Analysis, 2012 ................................................................... 73
Table 26: Product Profile – HeartMate II ............................................................................. 74
Table 27: HeartMate II SWOT Analysis, 2012 ..................................................................... 75
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Table 28: REVIVE-IT .......................................................................................................... 76
Table 29: ROADMAP ......................................................................................................... 76
Table 30: REMATCH .......................................................................................................... 77
Table 31: Product Profile – HVAD ....................................................................................... 78
Table 32: HVAD SWOT Analysis, 2012 .............................................................................. 79
Table 33: ENDURANCE ..................................................................................................... 80
Table 34: ADVANCE .......................................................................................................... 81
Table 35: Product Profile – Incor ......................................................................................... 82
Table 36: Incor SWOT Analysis, 2012 ................................................................................ 83
Table 37: Product Profile – IVAD ........................................................................................ 84
Table 38: IVAD SWOT Analysis, 2012 ................................................................................ 85
Table 39: Product Profile – Jarvik 2000 ............................................................................... 86
Table 40: Jarvik 2000 SWOT Analysis, 2012 ...................................................................... 87
Table 41: Jarvik 2000 US Pivotal DT Trial ........................................................................... 88
Table 42: Product Profile – Impella ..................................................................................... 91
Table 43: Impella SWOT Analysis, 2012 ............................................................................. 92
Table 44: Product Profile – Synergy .................................................................................... 93
Table 45: Synergy SWOT Analysis, 2012 ........................................................................... 94
Table 46: Synergy CE Mark EU Trial .................................................................................. 94
Table 47: Product Profile – TandemHeart ........................................................................... 95
Table 48: TandemHeart SWOT Analysis, 2012 ................................................................... 96
Table 49: TandemHeart to Reduce Infarct Size (TRIS)........................................................ 97
Table 50: Product Profile – AutoCAT 2 Wave .................................................................... 100
Table 51: AutoCAT 2 SWOT Analysis, 2012 ..................................................................... 101
Table 52: Product Profile – CardioSave ............................................................................ 102
Table 53: CardioSave SWOT Analysis, 2012 .................................................................... 103
Table 54: Product Profile – CS300 .................................................................................... 104
Table 55: CS300 SWOT Analysis, 2012............................................................................ 105
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Table 56: Product Profile – iVAC....................................................................................... 106
Table 57: iVAC SWOT Analysis, 2012 .............................................................................. 106
Table 58: Product Profile – Xemex .................................................................................... 107
Table 59: Xemex SWOT Analysis, 2012 ........................................................................... 107
Table 60: Comparing Leading CAD Products .................................................................... 109
Table 61: Product Profile – C-Pulse .................................................................................. 110
Table 62: C-Pulse SWOT Analysis, 2012 .......................................................................... 112
Table 63: C-Pulse US Pivotal Trial .................................................................................... 113
Table 64: Product Profile – AbioCor .................................................................................. 115
Table 65: AbioCor SWOT Analysis, 2012.......................................................................... 116
Table 66: Product Profile – SynCardia .............................................................................. 118
Table 67: SynCardia SWOT Analysis, 2012 ...................................................................... 119
Table 68: Risk Prediction Models ...................................................................................... 126
Table 69: Cardiac Assist Devices in Pipeline..................................................................... 133
Table 70: Product Profile – CorAide, DexAide ................................................................... 134
Table 71: CorAide, DexAide SWOT Analysis, 2012........................................................... 135
Table 72: Product Profile – DuraHeart II............................................................................ 136
Table 73: DuraHeart II SWOT Analysis, 2012 ................................................................... 136
Table 74: Product Profile – HeartMate III .......................................................................... 137
Table 75: HeartMate III SWOT Analysis, 2012 .................................................................. 137
Table 76: Product Profile – HeartMate X ........................................................................... 138
Table 77: HeartMate X SWOT Analysis, 2012 ................................................................... 138
Table 78: Product Profile – MiFlow ................................................................................... 139
Table 79: MiFlow SWOT Analysis, 2012 ........................................................................... 139
Table 80: Product Profile – MiTiHeart Corporation ............................................................ 140
Table 81: MiTiHeart SWOT Analysis, 2012 ....................................................................... 141
Table 82: Product Profile – MVAD .................................................................................... 142
Table 83: MVAD SWOT Analysis, 2012 ............................................................................ 143
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Table 84: Product Profile – PediaFlow .............................................................................. 144
Table 85: PediaFlow SWOT Analysis, 2012 ...................................................................... 144
Table 86: Product Profile – PediPump .............................................................................. 145
Table 87: PediPump SWOT Analysis, 2012 ...................................................................... 145
Table 88: Product Profile – Revolution .............................................................................. 146
Table 89: Revolution SWOT Analysis, 2012 ...................................................................... 146
Table 90: Product Profile – s.pump ................................................................................... 147
Table 91: s.pump SWOT Analysis, 2012 ........................................................................... 147
Table 92: Product Profile – HeartMate PHP ...................................................................... 148
Table 93: HeartMate PHP SWOT Analysis, 2012 .............................................................. 148
Table 94: Product Profile – Reitan Catheter Pump ............................................................ 149
Table 95: Reitan Catheter Pump SWOT Analysis, 2012 .................................................... 150
Table 96: Product Profile – AbioCor II ............................................................................... 151
Table 97: AbioCor II SWOT Analysis, 2012 ....................................................................... 151
Table 98: Product Profile – Carmat ................................................................................... 152
Table 99: Carmat SWOT Analysis, 2012 ........................................................................... 153
Table 100: Product Profile – Golding TAH........................................................................... 154
Table 101: Golding TAH SWOT Analysis, 2012 .................................................................. 154
Table 102: Product Profile – Beatless Heart ........................................................................ 155
Table 103: Beatless Heart SWOT Analysis, 2012 ............................................................... 156
Table 104: Product Profile – MagScrew .............................................................................. 157
Table 105: MagScrew SWOT Analysis, 2012 ...................................................................... 157
Table 106: Product Profile – ReinHeart ............................................................................... 158
Table 107: ReinHeart SWOT Analysis, 2012 ...................................................................... 158
Table 108: Company Profile – Abiomed, Inc. ...................................................................... 159
Table 109: Abiomed SWOT Analysis, 2012 ........................................................................ 160
Table 110: Company Profile – Berlin Heart ......................................................................... 161
Table 111: Berlin Heart SWOT Analysis, 2012 .................................................................... 162
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Table 112: Company Profile – Cardiac Assist ..................................................................... 163
Table 113: Cardiac Assist SWOT Analysis, 2012 ................................................................ 163
Table 114: Company Profile - CardioBridge ........................................................................ 164
Table 115: CardioBridge SWOT Analysis, 2012 .................................................................. 164
Table 116: Company Profile - Carmat ................................................................................. 165
Table 117: Carmat SWOT Analysis, 2012 ........................................................................... 165
Table 118: Company Profile - CircuLite ............................................................................... 166
Table 119: CircuLite SWOT Analysis, 2012 ........................................................................ 166
Table 120: Company Profile – HeartWare ........................................................................... 168
Table 121: HeartWare SWOT Analysis, 2012 ..................................................................... 169
Table 122: Company Profile – Jarvik Heart ......................................................................... 170
Table 123: Jarvik Heart SWOT Analysis, 2012 .................................................................... 171
Table 124: Company Profile – Maquet Cardiovascular ........................................................ 172
Table 125: Maquet Cardiovascular SWOT Analysis, 2012 .................................................. 172
Table 126: Company Profile – Medos Medizintechnik AG ................................................... 173
Table 127: Medos Medizintechnik AG SWOT Analysis, 2012 .............................................. 173
Table 128: Company Profile – MicroMed Cardiovascular, Inc. ............................................. 174
Table 129: MicroMed Cardiovascular SWOT Analysis, 2012 ............................................... 175
Table 130: Company Profile – MiTiHeart Corporation ......................................................... 176
Table 131: MiTiHeart Corporation SWOT Analysis, 2012 .................................................... 176
Table 132: Company Profile – PulseCath............................................................................ 177
Table 133: PulseCath SWOT Analysis, 2012 ...................................................................... 177
Table 134: Company Profile – Sunshine Heart .................................................................... 178
Table 135: Sunshine Heart SWOT Analysis, 2012 .............................................................. 179
Table 136: Company Profile – SynCardia Systems ............................................................. 180
Table 137: SynCardia Systems SWOT Analysis, 2012 ........................................................ 181
Table 138: Company Profile - Teleflex ................................................................................ 182
Table 139: Teleflex SWOT Analysis, 2012 .......................................................................... 182
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Table 140: Company Profile – Terumo Heart ...................................................................... 183
Table 141: Terumo Heart SWOT Analysis, 2012 ................................................................. 184
Table 142: Company Profile – Thoratec .............................................................................. 186
Table 143: Thoratec SWOT Analysis, 2012 ........................................................................ 189
Table 144: Company Profile – Sun Medical ........................................................................ 190
Table 145: Sun Medical SWOT Analysis, 2012 ................................................................... 190
Table 146: Company Profile – Zeon Medical ....................................................................... 191
Table 147: Zeon Medical SWOT Analysis, 2012 ................................................................. 191
Table 148: Heart Failure, Prevalence (% total population, n [millions]), US, 2010–2019 ...... 193
Table 149: Population Aged 65 Years and Above as Percentage of Overall Population, Global,
1960–2050 ........................................................................................................ 196
Table 150: Cardiac Assist Devices, Average Selling Price ($),US, 2012 .............................. 200
Table 151: US CAD Revenue ($m), 2010–2019 .................................................................. 204
Table 152: Sources of Epidemiological Data Used for the Forecast..................................... 222
Table 153: New York Heart Association (NYHA) Class Distributions Description ................. 224
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1.2 List of Figures
Figure 1: Classifications of Heart Failure.............................................................................. 23
Figure 2: Stages of Heart Failure Based on Diagnosis ......................................................... 33
Figure 3: Treatment Modalities for Heart Failure .................................................................. 38
Figure 4: Cardiac Assist Devices, Market Dynamics .......................................................... 192
Figure 5: Heart Failure, Prevalence (million), US, 2010–2019 ............................................ 193
Figure 6: Population Aged 65 Years and Above as Percentage of Overall Population, Global,
1960–2050 ......................................................................................................... 196
Figure 7: US CAD Revenue ($m), 2010–2019 ................................................................... 204
Figure 8: CAD Purchases vs. Heart Transplants, US (N), 2010–2019 ................................ 205
Introduction
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2 Introduction
Cardiac Assist Devices (CAD) are mechanical pumps that work in conjunction with a patient’s heart
to improve the pumping efficiency, increase the cardiac output and restore normal blood circulation.
The devices are typically employed in patients suffering from end-stage Congestive Heart Failure
(CHF), where the chances of survival through oral medications alone become minimal. The scarcity
of donor organs has led to the development of interim interventions that utilize CADs, which
comprise three segments: Ventricular Assist Devices (VAD), Intra-Aortic Balloon Pumps (IABP),
and Total Artificial Hearts (TAH).
These mechanical pumps are typically used for short-term purposes, allowing the heart to rest long
enough that it can recuperate and return to normal and independent function. This is especially
helpful for treating postcardiotomy cardiogenic shock, as these devices can provide a Bridge-To-
Transplantation (BTT) or Bridge-To-Recovery (BTR) option for patients with end-stage heart failure.
CADs can also be used for long-term Destination Therapy (DT) treatments in patients who are not
surgical candidates for transplant but have severe heart failure. As donor hearts can be extremely
difficult to get, CADs offer an alternative option for patients with critical heart failure who are waiting
to receive a donor heart.
2.1 Catalyst
Significant limitations and unmet needs with heart transplantation have generated considerable,
continued interest in the development of CADs that are capable of supporting patients with severe
CHF, either until donor hearts become available or as an alternative to heart transplantation for
long-term use. These CAD devices include Ventricular Assist Devices, Intra-Aortic Balloon Pumps,
and Total Artificial Hearts.
While heart transplantation remains the gold standard and preferred treatment option for
patients with advanced Congestive Heart Failure (CHF), the number of transplant candidates
far exceeds the donor pool.
The International Society for Heart and Lung Transplantation Registry 2012 Report notes a
worldwide continued decrease in the number of donor hearts available.
Advanced CHF patients on inotropic support have a mortality rate of 50% at three months and
94% at one year; cardiac assist devices can support these end-stage patients with significantly
better survival rates.
Many heart failure patients are ineligible for transplant due to old age or comorbidities;
approximately 50% of patients who need a transplant are disqualified due to age.
Opportunistic infection, rejection, malignancy, and graft coronary artery disease continue to be
limitations to heart transplantation.
Introduction
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It has been shown that implantation of a CAD earlier on during the CHF progression can
significantly slow the worsening of the condition, and in some cases even reverse the process
to improve patient condition. CADs can greatly improve organ function.
Destination therapy or tandem therapy, with a CAD in combination with cell transplantation, genetic
treatment, or drug therapy, may be an alternative option to circumvent the shortage of donor hearts
worldwide.
Appendix
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10.11 About GlobalData
GlobalData is a leading global provider of business intelligence in the Healthcare industry.
GlobalData provides its clients with up-to-date information and analysis on the latest developments
in medical device research, disease analysis, and clinical research and development. Our
integrated business intelligence solutions include a range of interactive online databases, analytical
tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team.
GlobalData has offices in New York, Boston, London, India and Singapore.
10.13 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any
form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior
permission of the publisher, GlobalData.