Cardiac Rhythm Management Devices World Markets

Executive Summary

This TriMark Publications report reviews the worldwide cardiac rhythm management market size for the U.S., European and Asian markets. Individual country markets such as Japan, the Philippines, Australia, and the Middle East are covered. Important regulatory issues that impact the use of cardiac rhythm devices are explored for countries like the U.S., Japan, Australian, Korea, India, China, Israel, the Philippines, and those in the E.U. Reimbursement strategies for the U.S. Medicare program and European and Japanese medical insurance programs are discussed. Also, a summary of current legal proceedings in this industry, which are often used for competitive purposes, is provided. It focuses sales and market trends for pacemakers, defibrillators, leads, and other related cardiac rhythm devices. The cardiac rhythm management markets are divided into the segments of: external defibrillators, implantable defibrillators, external pacemakers, implantable pacemakers, and defibrillator and pacemaker electrodes and leads heart failure specialty products.


1.0 Executive Summary 8
1.1 Methodology 11
1.2 Overview of Report Objectives 11

2.0 Medical Device Market Overview 13
2.1.1 U.S. Medical Device Industry 13
2.1.2 China 17
2.1.3 Hong Kong 18
2.1.4 Taiwan 18
2.1.5 Singapore 18
2.1.6 Japan 18
2.1.7 Canadian Medical Device Market 18
2.1.8 European Medical Device Market 19
2.1.9 U.S. Cardiac Rhythm Management Market 21
2.1.10 European Market 23
2.1.11 Asian Market 24
2.1.11.1 Japanese Market Overview 24
2.1.11.2 Japanese Medical Practice 28
2.1.11.3 Japanese Distribution/Business Practices 28
2.1.11.4 Japanese Pricing 28
2.1.11.5 The Philippines Market 30
2.1.12 Australian Market 30
2.1.13 Middle Eastern Market 31
2.2 Cardiovascular Conditions Treated with Defibrillation and/or Pacing Devices 31
2.2.1 Cardiac Rhythm Management 32
2.2.2 Conditions Treated 32
2.2.2.1 Bradycardia 33
2.2.2.2 Tachyarrhythmia 34
2.2.2.3 Heart Failure 36
2.2.2.4 Atrial Fibrillation 36
2.3 Principal Products 37
2.3.1 Implantable Cardiac Rhythm Devices for Bradycardia 38
2.3.1.1 Single-Chamber Pacemakers 38
2.3.1.1.1 Non-Rate Responsive Devices 38
2.3.1.1.2 Rate Responsive Devices 38
2.3.2 Dual-Chamber Pacemakers 38
2.3.3 Pacemakers by Manufacturer 39
2.3.3.1 ELA Medical (Sorin/Sina) 39
2.3.3.2 Guidant 39
2.3.3.3 Medtronic 40
2.3.3.4 St. Jude Medical 40
2.3.3.5 CCC Del Uruguay SA 40
2.3.3.6 Fiab Spa (Italy) 40
2.3.3.7 NeuroCor 40
2.3.3.8 Pace Medical Inc. 40
2.3.4 Implantable Cardiac Rhythm Devices for Tachycardia 41
2.3.4.1 Tachyarrhythmia Devices 41
2.3.4.2 Biotronik 42
2.3.4.3 ELA Medical 42
2.3.4.4 Guidant 42
2.3.4.5 Medtronic 44
2.3.4.6 St. Jude Medical 44
2.3.4.7 Defibrillators Growth Drivers 44
2.3.4.8 Factors Limiting the Growth of Defibrillators 44
2.3.5 Implantable Cardiac Rhythm Devices for Heart Failure 44
2.3.6 External Products 45
2.3.6.1 Defibrillators 45
2.3.6.2 Transesophageal Pacing 46
2.3.7 Product Innovations 47
2.3.7.1 Miniaturization 47
2.3.7.2 Modular Designs 47
2.3.7.3 New Products 47
2.4 Patient Management 48
2.5 Regulatory Issues - Government Regulation 48
2.5.1 U.S. Regulation 48
2.5.1.1 Importing Medical Devices into the U.S. 51
2.5.1.2 Exporting Medical Devices from the U.S. 52
2.5.2 U.K. Regulation 52
2.5.3 EU Regulation 54
2.5.4 Japanese Regulation 55
2.5.5 Australian Regulation 56
2.5.6 Korea Regulation 57
2.5.7 India Regulation 57
2.5.8 Registration for Imported Medical Devices in China 58
2.5.9 Israel 58
2.5.10 The Philippines 58
2.5.11 Overseas Testing to Increase Time-to-Market 58
2.6 Guidelines and Trade Organizations 59
2.6.1 American Heart Association (AHA) 59
2.6.2 Health Industry Manufacturers Association (HIMA) 59
2.7 Other Factors Influencing Cardiac Rhythm Management Devices 59
2.8 Worldwide Developments 60
2.9 Reimbursement 60
2.9.1 U.S. Reimbursement 60
2.9.1.1 Category "C" Codes 61
2.9.1.2 Medicare Decision on MADIT Reimbursements 61
2.9.2 European Reimbursement 62
2.9.3 Japanese Reimbursement 62
2.10 Legal Proceedings 63
2.11 Competition 68
2.12 Strategic Corporate Developments 69
2.12.1 Acquisitions 69
2.12.2 Partnerships 71
2.13.3 Other Developments 71
2.13.4 Product Launches 71

3.0 The External Defibrillator Market 74
3.1 Defibrillators Overview 74
3.2 External Automated Defibrillators 74
3.3 Analysis of Major Competitors 78

4.0 The Implantable Defibrillator Market 83
4.1 Overview 83
4.1.1 Market Drivers for ICDs 83
4.2 The Worldwide Market 85
4.3 The U.S. Market 86
4.4 Japanese Market 87
4.5 Analysis of Major Competitors 87
4.5.1 Biotronik 89
4.5.2 Guidant Corporation 89
4.5.3 Medtronic 90
4.5.4 St. Jude Medical 92
4.5.5 ELA Medical 92
4.5.6 Japan Lifeline (JLL) 93
4.5.7 Cardiac Rhythm Management 93

5.0 The External Pacemakers Market 94
5.1 Overview 94
5.2 The U.S. Market 94
5.3 The Worldwide Market 95
5.4 Analysis of Major Competitors 96
5.5 Transvenous External Pacemakers 97
5.6 Transvenous Pacemakers’ Development 97

6.0 The Implantable Pacemakers Market 98
6.1 Overview 98
6.2 The Worldwide Market 98
6.3 The U.S. Market 99
6.4 Analysis of Major Competitors 101
6.5 Transvenous Temporary Pacemakers 106

7.0 Market Overview 107
7.1.1 Defibrillator and Pacemaker Lead/Electrode Markets 107
7.1.2 Lead Extraction Market 108
7.1.3 Electrode Tips and Rings 108
7.2 The Worldwide Market 108
7.3 The U.S. Market 110
7.4 Analysis of Major Competitors 111
7.4.1 Cardiotronic 112
7.4.2 Guidant Corporation 112
7.4.3 Medtronic 112
7.4.4 St. Jude Medical 113
7.4.5 Zoll Medical 115
7.4.6 Biomec 115
7.4.7 ELA Medical 115
7.4.8 Sorin Biomedica 115
7.4.9 Biotronik 115
7.4.10 DR-ING P Osypka GmbH 115
7.4.11 CardioDynamics 116

8.0 Heart Failure Products 117
8.1 Overview 117
8.2 Heart Failure Conditions 118
8.3 Heart Failure Technology Platforms 118
8.4 Patient Management through the Internet 120

9.0 Company Profiles 121
9.1 Cardiac Science Inc. 121
9.2 Ballard Medical Products (Cardiotronic Systems Inc.) Kimberly-Clarke 123
9.3 Guidant Corporation 125
9.4 HeartBeat Medical Corporation 129
9.5 Medtronic Inc. 130
9.6 Pace Medical Inc. 134
9.7 St. Jude Medical, Inc. 137
9.8 Zoll Medical Corporation 141
9.9 General Electric Corporation Medical Division 144
9.10 Koninklijke Philips Electronics 145
9.11 Thoratec Corporation 147
9.12 Biomec Inc. 151
9.13 ELA Medical 151
9.14 Sorin Biomedica/ELA 153
9.15 Biotronik 154
9.16 Japan Lifeline 155
9.17 Cook Vascular Inc. 155
9.18 Emtel 155
9.19 Heraeus 156
9.20 Mayo Healthcare 156
9.21 VascoMed, GmbH 156
9.22 Oscor, GmbH 158
9.23 CardioDynamics International Corp. 159
9.24 Vermed 160

10.0 Industry Trends 161

11.0 Corporate Directory 163

Appendix 1: Cardiac Rhythm CPT Codes for Medicare 165
Appendix 2: New European Guideline for Defibrillator Implants 166
Appendix 3: Cardiovascular Device Manufacturers Internet Links 167
Appendix 4: Reimbursement CPT/APC Codes for Pacing Monitors 171
Appendix 5: Frequently Asked Questions on Transesophageal Cardiology 172
Appendix 6: Revision of Japanese Medical Device Approval Applications Classifications 176
Appendix 7: Medical Device Regulatory Requirements for Australia 178
Appendix 8: Regulation of Medical Devices in China 183
Appendix 9: Chinese Laboratories Accredited by the State Drug Administration for Product Testing 187


INDEX OF TABLES

Table 1: Worldwide Medical Manufacturing, 2002 2010 13
Table 2: U.S. Domestic Medical Device Exports (Except Ophthalmic) Annual, 1995 2000 14
Table 3: U.S. Medical Equipment (Except Ophthalmic) Imports for Consumption Annual, 1995 2000 15
Table 4: Surgical and Medical Instruments: U.S. Domestic Exports Annual, 1995 2000 16
Table 5: Surgical and Medical Supplies: U.S. Imports For Consumption Annual, 1995 2000 17
Table 6: Destinations of Canadian Medical Device Exports, 1998 2000 19
Table 7: Summary of the Total U.S. Defibrillator Market, 2001 and 2008 20
Table 8: Summary of the Total Worldwide Defibrillator Market, 2001 and 2008 20
Table 9: Summary of the Total U.S. Pacemaker Market, 2001 and 2008 20
Table 10: Summary of the Total Worldwide Pacemaker Market, 2001 and 2008 20
Table 11: Summary of the Total U.S. and Worldwide Defibrillator and Pacemaker Market, 2001 and 2008 21
Table 12: Estimated Number of Worldwide Patients with New Defibrillator or Pacemaker Implants, 2001 21
Table 13: Estimated Number of U.S. Patients with New Defibrillator and Pacemaker Implants, 2002 22
Table 14: Estimated Market Share of U.S. Defibrillator and Pacemaker Devices, 2001 22
Table 15: The U.S. Pacemaker and Defibrillator Market Size, 2001 2008 23
Table 16: Estimated Number of European Patients with New Defibrillator and Pacemaker Implants, 2002 23
Table 17: The European Pacemaker and Defibrillator Market 23
Table 18: Estimated Number of New Defibrillator and Pacemaker Implants for Europe, 2001 2008 24
Table 19: Japanese Medical Equipment Market 25
Table 20: Japanese Medical Equipment Market Estimated Import Market Share, 2002 26
Table 21: Japanese Implantable Device Market, 1994 2008 26
Table 22: Japanese Pacemaker and Defibrillator Market, 1994 2008 27
Table 23: Estimated Number of New Defibrillator and Pacemaker Implants for Japan, 2001 2004 27
Table 24: Country Medical Device Prices: Converted on the Purchasing-Power Parity Basis 29
Table 25: Cardiac Management Activity Cost: Converted on the Purchasing-Power Parity Basis 30
Table 26: Estimated Number of New Defibrillator and Pacemaker Implants for the Philippines, 2001 2004 30
Table 27: Estimated Number of New Defibrillator and Pacemaker Implants for Australia 31
Table 28: Population and Physician Statistics for Countries with Medical Devices 31
Table 29: Types of Defibrillators 41
Table 30: New Technological Developments in the ICDs Market 41
Table 31: External Defibrillators 46
Table 32: Seven-Year Summary of Low Risk Device Applications and Review Times, 1995 2001 60
Table 33: Cardiac Rhythm Management Business, 2000-2002 69
Table 34: U.S. External Defibrillator Market, 1990-2008 75
Table 35: Estimated Worldwide External Defibrillator Market Share Standings, 2001 77
Table 36A: Worldwide External Defibrillator Market, 1990-2008 77
Table 36B: Royal Phillips Electronics U.S. External Defibrillator Home Market, 2000-2008 82
Table 36C: Market Drivers for ICDs 83
Table 37: Worldwide Implantable Defibrillator Market, 2000-2008 85
Table 38: U.S. Implantable Defibrillator Market, 2000-2008 86
Table 39: Estimated U.S. ICD Manufacturer Market Share, 2002 87
Table 40: Estimated Worldwide ICD Manufacturer Market Share, 2002 87
Table 41: Estimated Worldwide ICD Manufacturer Market Share, 2000-2002 87
Table 42: ICD Share of the Cardiac Rhythm Management Business for Key Players 89
Table 43: Estimated U.S. ICD Manufacturer Market Share, 2000-2002 89
Table 44: U.S. External Pacemaker Market, 1990-2008 95
Table 45: Worldwide External Pacemaker Manufacturer Market Share Standings, 2002 95
Table 46: Worldwide External Pacemaker Market, 1990-2008 96
Table 47: Worldwide Implantable Pacemaker Markets, 2000-2008 99
Table 48: Worldwide Implantable Pacemaker Manufacturer Market Share Standings, 2002 99
Table 49: U.S. Implantable Pacemaker Market, 2000-2008 100
Table 50: U.S. Sales of Implantable Pacemakers by Device Type, 2002 100
Table 51: U.S. Implantable Pacemaker Manufacturer Market Share Standings, 2002 100
Table 52: U.S. Pacemaker Manufacturer Market Share, 2000-2002 101
Table 53: Pacemaker Share of the Cardiac Rhythm Management Business for Key Players 102
Table 54: U.S. Pacemaker Manufacturer Market Share, 2000-2002 102
Table 55: Worldwide Defibrillator/Pacing Leads Market, 1990-2008 109
Table 56: Worldwide External Defibrillator Electrode Market, 1990-2008 109
Table 57: Worldwide External Defibrillator Electrode Manufacturer Market Share Standings, 2002 110
Table 58: U.S. Defibrillator/Pacing Leads Market, 1990-2008 110
Table 59: U.S. External Defibrillator Electrode Market, 1990-2008 111
Table 60A: U.S. Defibrillator and Pacing Lead Manufacturer Market Share Standings, 2002 111
Table 60B: AV Nodal Ablation Procedures for AF in the U.S. 114
Table 61: Guidant Financials ($ Thousands) 125
Table 62A: Guidant Cardiac Rhythm Net Sales 126
Table 62B: Guidant Business Unit Sales Share 126
Table 63: Medtronic Five Year Sales Summary 131
Table 64: Medtronic Consolidated Net Sales 2003 131
Table 65: Medtronic Cardiac Rhythm Net Sales 131
Table 66: St. Jude Medical Financials, 2002 138
Table 67: St. Jude Sales by Division 138
Table 68: St. Jude Medical Net Sales by Geographic Markets 138
Table 69: St. Jude Cardiac Rhythm Net Sales 139
Table 70: Japan Lifeline Ltd. Ownership 155
Table 71: Vasco Pacing Leads 157


INDEX OF FIGURES

Figure 1: Comparison of Global Medical Technology Markets 19
Figure 2: Global Cardiac Rhythm Market 21
Figure 3: Worldwide Implantable Defibrillator Market 85
Figure 4: Worldwide ICD Manufacturer Market Share 2002 88
Figure 5: Cardiac Rhythm Management Business: 2000, 2001 and 2002 88
Figure 6: Medtronic Net Sales, 2001, 2002 104
Figure 7: Cardiac Rhythm Management Net Sales 132
Figure 8: Cardiac Impedance Cardiography Equipment Market Share by Location of Use 160
Figure 9: Cardiac Sensors Market Share by Location of Usage 160