Cardiac Assist Devices - MarketResearch · Expanding indications will drive future device sales: “In the future, we will see older patients, more permanent devices, also younger

Cardiac Assist Devices US Analysis and Market Forecasts

GDME1024CFR / Published March 2013

Executive Summary

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 2 GDME1024CFR / Published MAR 2013

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


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


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.”


Executive Summary


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.”


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.”


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].”


Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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


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


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.

Documents

Cardiac Assist Devices - MarketResearch · Expanding indications will drive future device sales: “In the future, we will see older patients, more permanent devices, also younger