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MediPoint: Cardiac Assist Devices - US Analysis and Market Forecasts

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NEW YORK, April 22, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

MediPoint: Cardiac Assist Devices - US Analysis and Market Forecasts
http://www.reportlinker.com/p01163183/MediPoint-Cardiac-Assist-Devices---US-Analysis-and-Market-Forecasts.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Cardiovascular_Devices

MediPoint: Cardiac Assist Devices - US Analysis and Market Forecasts

Summary

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).

A number of devices have been used in the US over the past 20 years, and many are no longer on the market. There are a number of CAD market drivers that will result in further adoption of the devices, although barriers still remain to be overcome before there is widespread use globally. The largest driver of CAD development is the lack of suitable options for an increasing large elderly CHF population.

The report provides insight into the competitive CAD landscape, including new companies entering the market and pipeline products in development. It quantifies the potential of long-term cardiac assist device use in end-stage heart failure patients awaiting transplantation, and examines the impact of this disruptive technology around the world. Included in the report is investigation of the highest growth sectors for CAD, with a focus on next-generation technologies due to enter the market, including transcutaneous energy transfer and fully implantable support systems.

Scope

- An overview of Congestive Heart Failure, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized US CAD market revenue and future forecasts from 2009 to 2011, forecast for 7 years to 2018.
- Investigation of current and future market competition for CAD
- Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
- Competitor assessment including device approval analysis and device sales forecasts.
- Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
- Analysis of unmet needs within the market and opportunities for future players.
- Technology trends evaluation to assess strength of pipeline.
- An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
- Company profiles including business description, financial overview and SWOT analysis.
- Coverage of key market players.
- Strategic assessment of the US device sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as cardiologists

Reasons to buy

- Understand the trends shaping and driving the US CAD Market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the US CAD Market through 2018.
- Quantify candidate patient populations to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
- Perform benchmarking analysis of growth opportunities against currently marketed products.
- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
- Take a comprehensive look at the market's device pipeline and identify promising, paradigm-shifting products.
- Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
- What's the next big thing in US CAD market landscape? Identify, understand and capitalize.

Table of Contents

1 Table of Contents 6
1.1 List of Tables 13
1.2 List of Figures 18
2 Introduction 19
2.1 Catalyst 19
3 Disease Overview – Congestive Heart Failure 21
3.1 Anatomy and Physiology 21
3.2 Pathophysiology 21
3.3 Types of Heart Failure 22
3.3.1 Classification by Progression 22
3.3.2 Classification by Location 23
3.3.3 Classification by Pumping Mechanism 23
3.4 Etiology 24
3.4.1 Conditions That Cause Heart Failure 24
3.4.2 Other Risk Factors 25
3.5 Clinical Presentation 29
3.5.1 Symptoms of Heart Failure 29
3.6 Diagnosis of Heart Failure 30
3.6.1 Stages of Heart Failure Based on Diagnosis 32
3.7 Epidemiology 34
3.7.1 US 34
3.8 Epidemiology Forecast (2012–2019) 35
3.8.1 Prevalent Cases of Congestive Heart Failure 35
3.9 Clinical Outcomes 35
3.9.1 Prognosis 35
3.9.2 Surgical Risk Stratification 36
3.10 Treatment Modalities 37
3.10.1 Medication 38
3.10.2 Surgery 38
3.10.3 Cardiac Assistance 39
3.10.4 Heart Transplantation 42
3.11 Economic Impact 43
3.11.1 Individual Costs 43
3.11.2 Industry Costs 44
4 Competitive Assessment 45
4.1 Cardiac Assist Device Market, Comparison of Key Marketed Products 45
4.2 Ventricular Assist Devices, Comparison based on Pump Technology 48
4.3 Ventricular Assist Devices 49
4.3.1 Overview 49
4.3.2 First-Generation Devices 50
4.3.3 Second-Generation Devices 51
4.3.4 Third-Generation Devices 51
4.3.5 Fourth-Generation Devices 52
4.3.6 Fifth-Generation Devices 52
4.3.7 Sixth-Generation Devices 52
4.3.8 Seventh-Generation Devices 52
4.3.9 Counterpulsation Devices 52
4.3.10 Adult Primary Implant Breakdown 53
4.3.11 Brand-Specific Training 53
4.4 Extracorporeal Ventricular Assist Devices 54
4.4.1 AB5000 (Abiomed, Inc.) 54
4.4.2 CentriMag, PediMag (Thoratec) 56
4.4.3 Delta-Stream DP3 Pump (Medos Medizintechnik AG) 59
4.4.4 Excor (Berlin Heart) 60
4.4.5 PVAD (Thoratec) 62
4.4.6 RotaFlow (Maquet Cardiovascular) 64
4.5 Intracorporeal Ventricular Assist Devices 66
4.5.1 DuraHeart (Terumo) 67
4.5.2 EvaHeart (Sun Medical Technology Research Corporation) 69
4.5.3 Heart Assist 5 (MicroMed Cardiovascular, Inc.) 71
4.5.4 HeartMate II (Thoratec) 73
4.5.5 HVAD (HeartWare) 77
4.5.6 Incor (Berlin Heart) 81
4.5.7 IVAD (Thoratec) 83
4.5.8 Jarvik 2000 (Jarvik Heart) 85
4.6 Percutaneous Ventricular Assist Devices 88
4.6.1 Impella (Abiomed, Inc.) 89
4.6.2 Synergy (CircuLite) 92
4.6.3 TandemHeart (Cardiac Assist, Inc.) 94
4.7 Intra-Aortic Balloon Pumps 97
4.7.1 Overview 97
4.7.2 AutoCAT 2 Wave (Teleflex) 99
4.7.3 CardioSave (Maquet Cardiovascular) 101
4.7.4 CS300 (Maquet Cardiovascular) 103
4.7.5 iVAC (PulseCath) 105
4.7.6 Xemex (Zeon) 106
4.8 Extra-Aortic Balloon Pumps 107
4.8.1 C-Pulse (Sunshine Heart) 109
4.9 Total Artificial Heart 113
4.9.1 Overview 113
4.9.2 AbioCor (Abiomed) 114
4.9.3 SynCardia (SynCardia Systems, Inc.) 116
4.10 Extracorporeal Membrane Oxygenation 118
5 Unmet Needs and Opportunities 119
5.1 Unmet Needs 120
5.1.1 Transcutaneous Energy Transfer to Reduce Risk of Infection and Improve Lifestyle 120
5.1.2 Anti-Coagulation to Reduce Risk of Stroke 122
5.1.3 Thromboresistant Coatings 122
5.1.4 Noncontact Bearing Design 123
5.2 Opportunities 124
5.2.1 Reduction of Rehospitalization Rates 124
5.2.2 NYHA Class III Patients 126
5.2.3 Destination Therapy 127
5.2.4 Pediatrics 129
5.2.5 Hybrid Combination Therapy 130
5.2.6 Mitral Valve Repair 131
6 Pipeline Products 132
6.1 Overview 132
6.2 Ventricular Assist Devices 133
6.2.1 CorAide, DexAide (Teleflex) 133
6.2.2 DuraHeart II (Terumo) 135
6.2.3 HeartMate III (Thoratec) 136
6.2.4 HeartMate X (Thoratec) 137
6.2.5 MiFlow (HeartWare) 138
6.2.6 MiTiHeart LVAD (Mohawk Innovative Technology, Inc.) 139
6.2.7 MVAD (HeartWare) 141
6.2.8 PediaFlow VAD (HeartWare) 143
6.2.9 PediPump (Cleveland Clinic) 144
6.2.10 Revolution (Vadovations, Inc.) 145
6.2.11 s.pump (Medos Medizintechnik AG) 146
6.3 Percutaneous Ventricular Assist Devices 147
6.3.1 HeartMate PHP (Thoratec) 147
6.3.2 Reitan Catheter Pump (CardioBridge GmbH) 148
6.4 Total Artificial Hearts 150
6.4.1 AbioCor II (Abiomed, Inc.) 150
6.4.2 Carmat TAH (Carmat) 151
6.4.3 Golding TAH (Cleveland Clinic) 153
6.4.4 Beatless Heart (Texas Heart Institute) 154
6.4.5 MagScrew (Cleveland Clinic) 156
6.4.6 ReinHeart (University of Aachen) 157
6.4.7 Other 157
7 Current and Future Players 158
7.1 Company Profiles 158
7.1.1 Abiomed, Inc. 158
7.1.2 Berlin Heart 160
7.1.3 CardiacAssist, Inc. 162
7.1.4 CardioBridge 163
7.1.5 Carmat 164
7.1.6 CircuLite 165
7.1.7 HeartWare International, Inc. 166
7.1.8 Jarvik Heart 169
7.1.9 Maquet Cardiovascular 171
7.1.10 Medos Medizintechnik AG 172
7.1.11 MicroMed Cardiovascular, Inc. 173
7.1.12 MiTiHeart Corporation 175
7.1.13 PulseCath BV 176
7.1.14 Sunshine Heart 177
7.1.15 SynCardia Systems, Inc. 179
7.1.16 Teleflex Medical 181
7.1.17 Terumo 182
7.1.18 Thoratec 184
7.1.19 Sun Medical 189
7.1.20 Zeon Medical 190
7.1.21 Other 190
8 Market Drivers, Opportunities, and Barriers 191
8.1 Market Drivers 192
8.1.1 Increasing Heart Failure Population 192
8.1.2 Technological Advancements, Miniaturizations, Leading to Increased Adoption by Physicians 193
8.1.3 Extensive Clinical Studies to Improve Adoption 193
8.1.4 Growing Patient Awareness and Increasing Numbers of Heart Centers 194
8.1.5 Aging Population to Drive Growth in Cardiac Assist Devices Market 195
8.2 Market Opportunities 197
8.2.1 Highly Under-Penetrated Market to Provide Significant Opportunity 197
8.2.2 Shortage of Donor Hearts for Transplantation Creates Opportunity 197
8.3 Market Barriers 198
8.3.1 Complications Associated with CAD 198
8.3.2 High Cost Makes Treatment Unaffordable 198
8.3.3 Alternative Therapies 199
8.3.4 Medical Device Tax Affects Manufacturers 199
8.3.5 Long Research and Development of Devices may Deter New Entrants into the Market 200
8.3.6 Complications Associated with Cardiac Assist Devices might Deter Physicians from Adoption of Their Use 200
8.4 Mergers and Acquisitions 200
8.4.1 Potential Sunshine Acquisition 200
9 Country Outlook and Forecasts 201
9.1 US 201
9.1.1 Overview 201
9.1.2 Reimbursement 202
9.1.3 Affordable Care Act Rehospitalization Fees 202
9.1.4 US CAD Market Revenue, 2010–2019 203
10 Appendix 205
10.1 Abbreviations 205
10.2 Bibliography 206
10.3 Methodology 220
10.3.1 Forecasting 220
10.3.2 Sources Used 220
10.3.3 Forecast Assumptions and Methods 221
10.4 Coverage 223
10.5 Secondary Research 223
10.6 Forecasting Methodology 224
10.6.1 Pricing Assumptions 224
10.7 Physicians and Specialists Included in this Study 225
10.8 Primary Research 226
10.9 About the Authors 227
10.9.1 Analysts 227
10.9.2 Global Head of Healthcare 228
10.10 Definitions 229
10.11 About GlobalData 230
10.12 Contact Us 230
10.13 Disclaimer 230

List of Tables

Table 1: New York Heart Association Scale 33
Table 2: American College of Cardiology Scale 33
Table 3: Prevalent Cases of Congestive Heart Failure, All Markets, Ages ?45 Years, Men and Women (n), 2012–2019 35
Table 4: Device Strategy at Time of Implant in US, 2011 40
Table 5: Cardiac Assist Devices by Launch 45
Table 6: Cardiac Assist Devices by Type 48
Table 7: Product Profile – AB5000 54
Table 8: AB5000 SWOT Analysis, 2012 55
Table 9: Product Profile – CentriMag, PediMag 57
Table 10: CentriMag, PediMag SWOT Analysis, 2012 58
Table 11: Product Profile – Delta-Stream DP3 Pump 59
Table 12: Delta-Stream DP3 SWOT Analysis, 2012 59
Table 13: Product Profile – Excor 60
Table 14: Excor SWOT Analysis, 2012 61
Table 15: Product Profile – PVAD 62
Table 16: PVAD SWOT Analysis, 2012 63
Table 17: Product Profile – RotaFlow 64
Table 18: RotaFlow SWOT Analysis, 2012 65
Table 19: Product Profile – DuraHeart 67
Table 20: DuraHeart SWOT Analysis, 2012 68
Table 21: Product Profile – EvaHeart 69
Table 22: EvaHeart SWOT Analysis, 2012 70
Table 23: EvaHeart US Pivotal BTT Trial 70
Table 24: Product Profile – HeartAssist 5 72
Table 25: HeartAssist 5 SWOT Analysis, 2012 72
Table 26: Product Profile – HeartMate II 73
Table 27: HeartMate II SWOT Analysis, 2012 74
Table 28: REVIVE-IT 75
Table 29: ROADMAP 75
Table 30: REMATCH 76
Table 31: Product Profile – HVAD 77
Table 32: HVAD SWOT Analysis, 2012 78
Table 33: ENDURANCE 79
Table 34: ADVANCE 80
Table 35: Product Profile – Incor 81
Table 36: Incor SWOT Analysis, 2012 82
Table 37: Product Profile – IVAD 83
Table 38: IVAD SWOT Analysis, 2012 84
Table 39: Product Profile – Jarvik 2000 85
Table 40: Jarvik 2000 SWOT Analysis, 2012 86
Table 41: Jarvik 2000 US Pivotal DT Trial 87
Table 42: Product Profile – Impella 90
Table 43: Impella SWOT Analysis, 2012 91
Table 44: Product Profile – Synergy 92
Table 45: Synergy SWOT Analysis, 2012 93
Table 46: Synergy CE Mark EU Trial 93
Table 47: Product Profile – TandemHeart 94
Table 48: TandemHeart SWOT Analysis, 2012 95
Table 49: TandemHeart to Reduce Infarct Size (TRIS) 96
Table 50: Product Profile – AutoCAT 2 Wave 99
Table 51: AutoCAT 2 SWOT Analysis, 2012 100
Table 52: Product Profile – CardioSave 101
Table 53: CardioSave SWOT Analysis, 2012 102
Table 54: Product Profile – CS300 103
Table 55: CS300 SWOT Analysis, 2012 104
Table 56: Product Profile – iVAC 105
Table 57: iVAC SWOT Analysis, 2012 105
Table 58: Product Profile – Xemex 106
Table 59: Xemex SWOT Analysis, 2012 106
Table 60: Comparing Leading CAD Products 108
Table 61: Product Profile – C-Pulse 109
Table 62: C-Pulse SWOT Analysis, 2012 111
Table 63: C-Pulse US Pivotal Trial 112
Table 64: Product Profile – AbioCor 114
Table 65: AbioCor SWOT Analysis, 2012 115
Table 66: Product Profile – SynCardia 117
Table 67: SynCardia SWOT Analysis, 2012 118
Table 68: Risk Prediction Models 125
Table 69: Cardiac Assist Devices in Pipeline 132
Table 70: Product Profile – CorAide, DexAide 133
Table 71: CorAide, DexAide SWOT Analysis, 2012 134
Table 72: Product Profile – DuraHeart II 135
Table 73: DuraHeart II SWOT Analysis, 2012 135
Table 74: Product Profile – HeartMate III 136
Table 75: HeartMate III SWOT Analysis, 2012 136
Table 76: Product Profile – HeartMate X 137
Table 77: HeartMate X SWOT Analysis, 2012 137
Table 78: Product Profile – MiFlow 138
Table 79: MiFlow SWOT Analysis, 2012 138
Table 80: Product Profile – MiTiHeart Corporation 139
Table 81: MiTiHeart SWOT Analysis, 2012 140
Table 82: Product Profile – MVAD 141
Table 83: MVAD SWOT Analysis, 2012 142
Table 84: Product Profile – PediaFlow 143
Table 85: PediaFlow SWOT Analysis, 2012 143
Table 86: Product Profile – PediPump 144
Table 87: PediPump SWOT Analysis, 2012 144
Table 88: Product Profile – Revolution 145
Table 89: Revolution SWOT Analysis, 2012 145
Table 90: Product Profile – s.pump 146
Table 91: s.pump SWOT Analysis, 2012 146
Table 92: Product Profile – HeartMate PHP 147
Table 93: HeartMate PHP SWOT Analysis, 2012 147
Table 94: Product Profile – Reitan Catheter Pump 148
Table 95: Reitan Catheter Pump SWOT Analysis, 2012 149
Table 96: Product Profile – AbioCor II 150
Table 97: AbioCor II SWOT Analysis, 2012 150
Table 98: Product Profile – Carmat 151
Table 99: Carmat SWOT Analysis, 2012 152
Table 100: Product Profile – Golding TAH 153
Table 101: Golding TAH SWOT Analysis, 2012 153
Table 102: Product Profile – Beatless Heart 154
Table 103: Beatless Heart SWOT Analysis, 2012 155
Table 104: Product Profile – MagScrew 156
Table 105: MagScrew SWOT Analysis, 2012 156
Table 106: Product Profile – ReinHeart 157
Table 107: ReinHeart SWOT Analysis, 2012 157
Table 108: Company Profile – Abiomed, Inc. 158
Table 109: Abiomed SWOT Analysis, 2012 159
Table 110: Company Profile – Berlin Heart 160
Table 111: Berlin Heart SWOT Analysis, 2012 161
Table 112: Company Profile – Cardiac Assist 162
Table 113: Cardiac Assist SWOT Analysis, 2012 162
Table 114: Company Profile - CardioBridge 163
Table 115: CardioBridge SWOT Analysis, 2012 163
Table 116: Company Profile - Carmat 164
Table 117: Carmat SWOT Analysis, 2012 164
Table 118: Company Profile - CircuLite 165
Table 119: CircuLite SWOT Analysis, 2012 165
Table 120: Company Profile – HeartWare 167
Table 121: HeartWare SWOT Analysis, 2012 168
Table 122: Company Profile – Jarvik Heart 169
Table 123: Jarvik Heart SWOT Analysis, 2012 170
Table 124: Company Profile – Maquet Cardiovascular 171
Table 125: Maquet Cardiovascular SWOT Analysis, 2012 171
Table 126: Company Profile – Medos Medizintechnik AG 172
Table 127: Medos Medizintechnik AG SWOT Analysis, 2012 172
Table 128: Company Profile – MicroMed Cardiovascular, Inc. 173
Table 129: MicroMed Cardiovascular SWOT Analysis, 2012 174
Table 130: Company Profile – MiTiHeart Corporation 175
Table 131: MiTiHeart Corporation SWOT Analysis, 2012 175
Table 132: Company Profile – PulseCath 176
Table 133: PulseCath SWOT Analysis, 2012 176
Table 134: Company Profile – Sunshine Heart 177
Table 135: Sunshine Heart SWOT Analysis, 2012 178
Table 136: Company Profile – SynCardia Systems 179
Table 137: SynCardia Systems SWOT Analysis, 2012 180
Table 138: Company Profile - Teleflex 181
Table 139: Teleflex SWOT Analysis, 2012 181
Table 140: Company Profile – Terumo Heart 182
Table 141: Terumo Heart SWOT Analysis, 2012 183
Table 142: Company Profile – Thoratec 185
Table 143: Thoratec SWOT Analysis, 2012 188
Table 144: Company Profile – Sun Medical 189
Table 145: Sun Medical SWOT Analysis, 2012 189
Table 146: Company Profile – Zeon Medical 190
Table 147: Zeon Medical SWOT Analysis, 2012 190
Table 148: Heart Failure, Prevalence (% total population, n [millions]), US, 2010–2019 192
Table 149: Population Aged 65 Years and Above as Percentage of Overall Population, Global, 1960–2050 195
Table 150: Cardiac Assist Devices, Average Selling Price ($),US, 2012 199
Table 151: US CAD Revenue ($m), 2010–2019 203
Table 152: Sources of Epidemiological Data Used for the Forecast 220
Table 153: New York Heart Association (NYHA) Class Distributions Description 222

List of Figures

Figure 1: Classifications of Heart Failure 22
Figure 2: Stages of Heart Failure Based on Diagnosis 32
Figure 3: Treatment Modalities for Heart Failure 37
Figure 4: Cardiac Assist Devices, Market Dynamics 191
Figure 5: Heart Failure, Prevalence (million), US, 2010–2019 192
Figure 6: Population Aged 65 Years and Above as Percentage of Overall Population, Global, 1960–2050 195
Figure 7: US CAD Revenue ($m), 2010–2019 203
Figure 8: CAD Purchases vs. Heart Transplants, US (N), 2010–2019 204

Companies Mentioned

Abiomed, Inc.
Berlin Heart
CardiacAssist, Inc.
CardioBridge
Carmat
CircuLite
HeartWare International, Inc.
Jarvik Heart
Maquet Cardiovascular
Medos Medizintechnik AG
MicroMed Cardiovascular, Inc.
MiTiHeart Corporation
PulseCath BV
Sunshine He

To order this report:
Cardiovascular_Devices Industry:
MediPoint: Cardiac Assist Devices - US Analysis and Market Forecasts

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