Cardiac Assist Devices - MarketResearch · Cardiac Assist Devices Current and Pipeline Products...

Cardiac Assist Devices Current and Pipeline Products

GDME1006FPR / Published March 2013

Table of Contents

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. GDME1006FPR / Published MAR 2013

1 Table of Contents

1 Table of Contents ............................................................................................................... 2

1.1 List of Tables ............................................................................................................... 7

1.2 List of Figures ........................................................................................................... 13

2 Introduction ....................................................................................................................... 14

2.1 Catalyst ..................................................................................................................... 14

3 Competitive Assessment ................................................................................................... 16

3.1 Cardiac Assist Device Market, Comparison of Key Marketed Products ...................... 16

3.2 Ventricular Assist Devices Market, Key Company Share ............................................ 18

3.3 Ventricular Assist Devices, Comparison based on Pump Technology ........................ 19

3.4 Ventricular Assist Devices ......................................................................................... 20

3.4.1 Overview............................................................................................................. 20

3.4.2 First-Generation Devices ..................................................................................... 21

3.4.3 Second-Generation Devices ................................................................................ 22

3.4.4 Third-Generation Devices ................................................................................... 22

3.4.5 Fourth-Generation Devices ................................................................................. 23

3.4.6 Fifth-Generation Devices ..................................................................................... 23

3.4.7 Sixth-Generation Devices .................................................................................... 23

3.4.8 Seventh-Generation Devices ............................................................................... 23

3.4.9 Counterpulsation Devices ................................................................................... 23

3.4.10 Adult Primary Implant Breakdown........................................................................ 24

3.4.11 Brand-Specific Training ....................................................................................... 24

3.5 Extracorporeal Ventricular Assist Devices .................................................................. 25

3.5.1 AB5000 (Abiomed, Inc.) ...................................................................................... 25

3.5.2 CentriMag, PediMag (Thoratec) .......................................................................... 27

3.5.3 Delta-Stream DP3 Pump (Medos Medizintechnik AG) ......................................... 30

3.5.4 Excor (Berlin Heart)............................................................................................. 31

Table of Contents


3.5.5 PVAD (Thoratec) ................................................................................................. 33

3.5.6 RotaFlow (Maquet Cardiovascular) ..................................................................... 35

3.6 Intracorporeal Ventricular Assist Devices ................................................................... 37

3.6.1 DuraHeart (Terumo) ............................................................................................ 38

3.6.2 EvaHeart (Sun Medical Technology Research Corporation) ................................ 40

3.6.3 Heart Assist 5 (MicroMed Cardiovascular, Inc.) ................................................... 42

3.6.4 HeartMate II (Thoratec) ....................................................................................... 44

3.6.5 HVAD (HeartWare) ............................................................................................. 48

3.6.6 Incor (Berlin Heart) .............................................................................................. 52

3.6.7 IVAD (Thoratec) .................................................................................................. 54

3.6.8 Jarvik 2000 (Jarvik Heart) ................................................................................... 56

3.7 Percutaneous Ventricular Assist Devices ................................................................... 59

3.7.1 Impella (Abiomed, Inc.) ....................................................................................... 60

3.7.2 Synergy (CircuLite) ............................................................................................. 63

3.7.3 TandemHeart (Cardiac Assist, Inc.) ..................................................................... 66

3.8 Intra-Aortic Balloon Pumps ........................................................................................ 69

3.8.1 Overview............................................................................................................. 69

3.8.2 AutoCAT 2 Wave (Teleflex) ................................................................................. 71

3.8.3 CardioSave (Maquet Cardiovascular) .................................................................. 73

3.8.4 CS300 (Maquet Cardiovascular) ......................................................................... 75

3.8.5 iVAC (PulseCath) ................................................................................................ 77

3.8.6 Xemex (Zeon) ..................................................................................................... 78

3.9 Extra-Aortic Balloon Pumps ....................................................................................... 79

3.9.1 C-Pulse (Sunshine Heart) ................................................................................... 81

3.10 Total Artificial Heart ................................................................................................... 85

3.10.1 Overview............................................................................................................. 85

3.10.2 AbioCor (Abiomed).............................................................................................. 86

3.10.3 SynCardia (SynCardia Systems, Inc.).................................................................. 88

Table of Contents


3.11 Extracorporeal Membrane Oxygenation ..................................................................... 91

4 Pipeline Products .............................................................................................................. 92

4.1 Overview ................................................................................................................... 92

4.2 Ventricular Assist Devices ......................................................................................... 93

4.2.1 CorAide, DexAide (Teleflex) ................................................................................ 93

4.2.2 DuraHeart II (Terumo) ......................................................................................... 95

4.2.3 HeartMate III (Thoratec) ...................................................................................... 96

4.2.4 HeartMate X (Thoratec)....................................................................................... 97

4.2.5 MiFlow (HeartWare) ............................................................................................ 98

4.2.6 MiTiHeart LVAD (Mohawk Innovative Technology, Inc.)....................................... 99

4.2.7 MVAD (HeartWare) ........................................................................................... 101

4.2.8 PediaFlow VAD (HeartWare) ............................................................................. 103

4.2.9 PediPump (Cleveland Clinic) ............................................................................. 104

4.2.10 Revolution (Vadovations, Inc.) ........................................................................... 105

4.2.11 s.pump (Medos Medizintechnik AG) .................................................................. 106

4.3 Percutaneous Ventricular Assist Devices ................................................................. 107

4.3.1 HeartMate PHP (Thoratec) ................................................................................ 107

4.3.2 Reitan Catheter Pump (CardioBridge GmbH) .................................................... 108

4.4 Total Artificial Hearts ............................................................................................... 110

4.4.1 AbioCor II (Abiomed, Inc.) ................................................................................. 110

4.4.2 Carmat TAH (Carmat) ....................................................................................... 111

4.4.3 Golding TAH (Cleveland Clinic) ......................................................................... 113

4.4.4 Beatless Heart (Texas Heart Institute) ............................................................... 114

4.4.5 MagScrew (Cleveland Clinic) ............................................................................ 116

4.4.6 ReinHeart (University of Aachen) ...................................................................... 117

4.4.7 Other ................................................................................................................ 117

5 Current and Future Players ............................................................................................. 118

5.1 Company Profiles .................................................................................................... 118

Table of Contents


5.1.1 Abiomed, Inc. .................................................................................................... 118

5.1.2 Berlin Heart ....................................................................................................... 120

5.1.3 CardiacAssist, Inc. ............................................................................................ 122

5.1.4 CardioBridge ..................................................................................................... 123

5.1.5 Carmat .............................................................................................................. 124

5.1.6 CircuLite ........................................................................................................... 125

5.1.7 HeartWare International, Inc. ............................................................................. 126

5.1.8 Jarvik Heart....................................................................................................... 129

5.1.9 Maquet Cardiovascular ..................................................................................... 131

5.1.10 Medos Medizintechnik AG ................................................................................. 132

5.1.11 MicroMed Cardiovascular, Inc. .......................................................................... 133

5.1.12 MiTiHeart Corporation ....................................................................................... 135

5.1.13 PulseCath BV ................................................................................................... 136

5.1.14 Sunshine Heart ................................................................................................. 137

5.1.15 SynCardia Systems, Inc. ................................................................................... 139

5.1.16 Teleflex Medical ................................................................................................ 141

5.1.17 Terumo ............................................................................................................. 142

5.1.18 Thoratec ........................................................................................................... 144

5.1.19 Sun Medical ...................................................................................................... 149

5.1.20 Zeon Medical .................................................................................................... 150

5.1.21 Other ................................................................................................................ 150

6 Appendix ........................................................................................................................ 151

6.1 Abbreviations .......................................................................................................... 151

6.2 Bibliography ............................................................................................................ 153

6.3 Methodology ........................................................................................................... 167

6.3.1 Forecasting ....................................................................................................... 167

6.3.2 Sources Used ................................................................................................... 168

6.3.3 Forecast Assumptions and Methods .................................................................. 171

Table of Contents


6.4 Coverage ................................................................................................................ 175

6.5 Secondary Research ............................................................................................... 175

6.6 Forecasting Methodology ........................................................................................ 176

6.6.1 Pricing Assumptions .......................................................................................... 176

6.7 Physicians and Specialists Included in this Study .................................................... 177

6.8 Primary Research.................................................................................................... 178

6.9 About the Authors ................................................................................................... 179

6.9.1 Analysts ............................................................................................................ 179

6.9.2 Global Head of Healthcare ................................................................................ 180

6.10 Definitions ............................................................................................................... 181

6.11 About GlobalData .................................................................................................... 182

6.12 Contact Us .............................................................................................................. 182

6.13 Disclaimer ............................................................................................................... 182

Table of Contents


1.1 List of Tables

Table 1: Cardiac Assist Devices by Launch....................................................................... 16

Table 2: Ventricular Assist Devices Market, Global, Company Share ($m), 2012 ............... 18

Table 3: Cardiac Assist Devices by Type .......................................................................... 19

Table 4: Product Profile – AB5000 .................................................................................... 25

Table 5: AB5000 SWOT Analysis, 2012 ............................................................................ 26

Table 6: Product Profile – CentriMag, PediMag ................................................................. 28

Table 7: CentriMag, PediMag SWOT Analysis, 2012 ........................................................ 29

Table 8: Product Profile – Delta-Stream DP3 Pump .......................................................... 30

Table 9: Delta-Stream DP3 SWOT Analysis, 2012 ............................................................ 30

Table 10: Product Profile – Excor........................................................................................ 31

Table 11: Excor SWOT Analysis, 2012 ............................................................................... 32

Table 12: Product Profile – PVAD ....................................................................................... 33

Table 13: PVAD SWOT Analysis, 2012 ............................................................................... 34

Table 14: Product Profile – RotaFlow .................................................................................. 35

Table 15: RotaFlow SWOT Analysis, 2012 ......................................................................... 36

Table 16: Product Profile – DuraHeart ................................................................................ 38

Table 17: DuraHeart SWOT Analysis, 2012 ........................................................................ 39

Table 18: Product Profile – EvaHeart .................................................................................. 40

Table 19: EvaHeart SWOT Analysis, 2012 .......................................................................... 41

Table 20: EvaHeart US Pivotal BTT Trial ............................................................................ 41

Table 21: Product Profile – HeartAssist 5 ............................................................................ 43

Table 22: HeartAssist 5 SWOT Analysis, 2012 ................................................................... 43

Table 23: Product Profile – HeartMate II ............................................................................. 44

Table 24: HeartMate II SWOT Analysis, 2012 ..................................................................... 45

Table 25: REVIVE-IT .......................................................................................................... 46

Table 26: ROADMAP ......................................................................................................... 46

Table 27: REMATCH .......................................................................................................... 47

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Table 28: Product Profile – HVAD ....................................................................................... 48

Table 29: HVAD SWOT Analysis, 2012 .............................................................................. 49

Table 30: ENDURANCE ..................................................................................................... 50

Table 31: ADVANCE .......................................................................................................... 51

Table 32: Product Profile – Incor ......................................................................................... 52

Table 33: Incor SWOT Analysis, 2012 ................................................................................ 53

Table 34: Product Profile – IVAD ........................................................................................ 54

Table 35: IVAD SWOT Analysis, 2012 ................................................................................ 55

Table 36: Product Profile – Jarvik 2000 ............................................................................... 56

Table 37: Jarvik 2000 SWOT Analysis, 2012 ...................................................................... 57

Table 38: Jarvik 2000 US Pivotal DT Trial ........................................................................... 58

Table 39: Product Profile – Impella ..................................................................................... 61

Table 40: Impella SWOT Analysis, 2012 ............................................................................. 62

Table 41: Product Profile – Synergy .................................................................................... 63

Table 42: Synergy SWOT Analysis, 2012 ........................................................................... 64

Table 43: Synergy CE Mark EU Trial .................................................................................. 65

Table 44: Product Profile – TandemHeart ........................................................................... 66

Table 45: TandemHeart SWOT Analysis, 2012 ................................................................... 67

Table 46: TandemHeart to Reduce Infarct Size (TRIS)........................................................ 68

Table 47: Product Profile – AutoCAT 2 Wave ...................................................................... 71

Table 48: AutoCAT 2 SWOT Analysis, 2012 ....................................................................... 72

Table 49: Product Profile – CardioSave .............................................................................. 73

Table 50: CardioSave SWOT Analysis, 2012 ...................................................................... 74

Table 51: Product Profile – CS300 ...................................................................................... 75

Table 52: CS300 SWOT Analysis, 2012.............................................................................. 76

Table 53: Product Profile – iVAC......................................................................................... 77

Table 54: iVAC SWOT Analysis, 2012 ................................................................................ 77

Table 55: Product Profile – Xemex ...................................................................................... 78

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Table 56: Xemex SWOT Analysis, 2012 ............................................................................. 78

Table 57: Comparing Leading CAD Products ...................................................................... 80

Table 58: Product Profile – C-Pulse .................................................................................... 81

Table 59: C-Pulse SWOT Analysis, 2012 ............................................................................ 83

Table 60: C-Pulse US Pivotal Trial ...................................................................................... 84

Table 61: Product Profile – AbioCor .................................................................................... 86

Table 62: AbioCor SWOT Analysis, 2012............................................................................ 87

Table 63: Product Profile – SynCardia ................................................................................ 89

Table 64: SynCardia SWOT Analysis, 2012 ........................................................................ 90

Table 65: Cardiac Assist Devices in Pipeline....................................................................... 92

Table 66: Product Profile – CorAide, DexAide ..................................................................... 93

Table 67: CorAide, DexAide SWOT Analysis, 2012............................................................. 94

Table 68: Product Profile – DuraHeart II.............................................................................. 95

Table 69: DuraHeart II SWOT Analysis, 2012 ..................................................................... 95

Table 70: Product Profile – HeartMate III ............................................................................ 96

Table 71: HeartMate III SWOT Analysis, 2012 .................................................................... 96

Table 72: Product Profile – HeartMate X ............................................................................. 97

Table 73: HeartMate X SWOT Analysis, 2012 ..................................................................... 97

Table 74: Product Profile – MiFlow ..................................................................................... 98

Table 75: MiFlow SWOT Analysis, 2012 ............................................................................. 98

Table 76: Product Profile – MiTiHeart Corporation .............................................................. 99

Table 77: MiTiHeart SWOT Analysis, 2012 ....................................................................... 100

Table 78: Product Profile – MVAD .................................................................................... 101

Table 79: MVAD SWOT Analysis, 2012 ............................................................................ 102

Table 80: Product Profile – PediaFlow .............................................................................. 103

Table 81: PediaFlow SWOT Analysis, 2012 ...................................................................... 103

Table 82: Product Profile – PediPump .............................................................................. 104

Table 83: PediPump SWOT Analysis, 2012 ...................................................................... 104

Table of Contents


Table 84: Product Profile – Revolution .............................................................................. 105

Table 85: Revolution SWOT Analysis, 2012 ...................................................................... 105

Table 86: Product Profile – s.pump ................................................................................... 106

Table 87: s.pump SWOT Analysis, 2012 ........................................................................... 106

Table 88: Product Profile – HeartMate PHP ...................................................................... 107

Table 89: HeartMate PHP SWOT Analysis, 2012 .............................................................. 107

Table 90: Product Profile – Reitan Catheter Pump ............................................................ 108

Table 91: Reitan Catheter Pump SWOT Analysis, 2012 .................................................... 109

Table 92: Product Profile – AbioCor II ............................................................................... 110

Table 93: AbioCor II SWOT Analysis, 2012 ....................................................................... 110

Table 94: Product Profile – Carmat ................................................................................... 111

Table 95: Carmat SWOT Analysis, 2012 ........................................................................... 112

Table 96: Product Profile – Golding TAH........................................................................... 113

Table 97: Golding TAH SWOT Analysis, 2012 .................................................................. 113

Table 98: Product Profile – Beatless Heart ........................................................................ 114

Table 99: Beatless Heart SWOT Analysis, 2012 ............................................................... 115

Table 100: Product Profile – MagScrew .............................................................................. 116

Table 101: MagScrew SWOT Analysis, 2012 ...................................................................... 116

Table 102: Product Profile – ReinHeart ............................................................................... 117

Table 103: ReinHeart SWOT Analysis, 2012 ...................................................................... 117

Table 104: Company Profile – Abiomed, Inc. ...................................................................... 118

Table 105: Abiomed SWOT Analysis, 2012 ........................................................................ 119

Table 106: Company Profile – Berlin Heart ......................................................................... 120

Table 107: Berlin Heart SWOT Analysis, 2012 .................................................................... 121

Table 108: Company Profile – Cardiac Assist ..................................................................... 122

Table 109: Cardiac Assist SWOT Analysis, 2012 ................................................................ 122

Table 110: Company Profile - CardioBridge ........................................................................ 123

Table 111: CardioBridge SWOT Analysis, 2012 .................................................................. 123

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Table 112: Company Profile - Carmat ................................................................................. 124

Table 113: Carmat SWOT Analysis, 2012 ........................................................................... 124

Table 114: Company Profile - CircuLite ............................................................................... 125

Table 115: CircuLite SWOT Analysis, 2012 ........................................................................ 125

Table 116: Company Profile – HeartWare ........................................................................... 127

Table 117: HeartWare SWOT Analysis, 2012 ..................................................................... 128

Table 118: Company Profile – Jarvik Heart ......................................................................... 129

Table 119: Jarvik Heart SWOT Analysis, 2012 .................................................................... 130

Table 120: Company Profile – Maquet Cardiovascular ........................................................ 131

Table 121: Maquet Cardiovascular SWOT Analysis, 2012 .................................................. 131

Table 122: Company Profile – Medos Medizintechnik AG ................................................... 132

Table 123: Medos Medizintechnik AG SWOT Analysis, 2012 .............................................. 132

Table 124: Company Profile – MicroMed Cardiovascular, Inc. ............................................. 133

Table 125: MicroMed Cardiovascular SWOT Analysis, 2012 ............................................... 134

Table 126: Company Profile – MiTiHeart Corporation ......................................................... 135

Table 127: MiTiHeart Corporation SWOT Analysis, 2012 .................................................... 135

Table 128: Company Profile – PulseCath............................................................................ 136

Table 129: PulseCath SWOT Analysis, 2012 ...................................................................... 136

Table 130: Company Profile – Sunshine Heart .................................................................... 137

Table 131: Sunshine Heart SWOT Analysis, 2012 .............................................................. 138

Table 132: Company Profile – SynCardia Systems ............................................................. 139

Table 133: SynCardia Systems SWOT Analysis, 2012 ........................................................ 140

Table 134: Company Profile - Teleflex ................................................................................ 141

Table 135: Teleflex SWOT Analysis, 2012 .......................................................................... 141

Table 136: Company Profile – Terumo Heart ...................................................................... 142

Table 137: Terumo Heart SWOT Analysis, 2012 ................................................................. 143

Table 138: Company Profile – Thoratec .............................................................................. 145

Table 139: Thoratec SWOT Analysis, 2012 ........................................................................ 148

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Table 140: Company Profile – Sun Medical ........................................................................ 149

Table 141: Sun Medical SWOT Analysis, 2012 ................................................................... 149

Table 142: Company Profile – Zeon Medical ....................................................................... 150

Table 143: Zeon Medical SWOT Analysis, 2012 ................................................................. 150

Table 144: Sources of Epidemiological Data Used for the Forecast..................................... 168

Table 145: New York Heart Association (NYHA) Class Distributions Description ................. 174

Table of Contents


1.2 List of Figures

Figure 1: Ventricular Assist Devices Market, Global, Company Share (%), 2012 .................. 18

Introduction


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


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

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 182 GDME1006FPR / Published MAR 2013

6.11 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.

6.13 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.

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