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Cardiac Rhythm Management Devices World Markets: Defibrillators, Pacemakers and Leads

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.

Table of Contents

• 1.0Executive Summary8
• 1.1Methodology11
• 1.2 Overview of Report Objectives11


• 2.0Medical Device Market Overview13
  • 2.1.1 U.S. Medical Device Industry13
  • 2.1.2 China17
  • 2.1.3 Hong Kong18
  • 2.1.4 Taiwan18
  • 2.1.5 Singapore18
  • 2.1.6 Japan18
  • 2.1.7 Canadian Medical Device Market18
  • 2.1.8 European Medical Device Market19
  • 2.1.9 U.S. Cardiac Rhythm Management Market21
  • 2.1.10 European Market23
  • 2.1.11 Asian Market24
    • 2.1.11.1Japanese Market Overview24
    • 2.1.11.2Japanese Medical Practice28
    • 2.1.11.3 Japanese Distribution/Business Practices28
    • 2.1.11.4 Japanese Pricing28
    • 2.1.11.5The Philippines Market30
  • 2.1.12Australian Market30
  • 2.1.13Middle Eastern Market31
• 2.2Cardiovascular Conditions Treated with Defibrillation and/or Pacing Devices31
  • 2.2.1Cardiac Rhythm Management32
  • 2.2.2Conditions Treated32
    • 2.2.2.1Bradycardia33
    • 2.2.2.2Tachyarrhythmia34
    • 2.2.2.3 Heart Failure36
    • 2.2.2.4Atrial Fibrillation36
• 2.3Principal Products37
  • 2.3.1Implantable Cardiac Rhythm Devices for Bradycardia38
    • 2.3.1.1Single-Chamber Pacemakers38
      • 2.3.1.1.1 Non-Rate Responsive Devices38
      • 2.3.1.1.2 Rate Responsive Devices38
  • 2.3.2Dual-Chamber Pacemakers38
  • 2.3.3 Pacemakers by Manufacturer39
    • 2.3.3.1 ELA Medical (Sorin/Sina)39
    • 2.3.3.2Guidant39
    • 2.3.3.3Medtronic40
    • 2.3.3.4St. Jude Medical40
    • 2.3.3.5CCC Del Uruguay SA40
    • 2.3.3.6Fiab Spa (Italy)40
    • 2.3.3.7NeuroCor40
    • 2.3.3.8Pace Medical Inc.40
  • 2.3.4Implantable Cardiac Rhythm Devices for Tachycardia41
    • 2.3.4.1Tachyarrhythmia Devices41
    • 2.3.4.2Biotronik42
    • 2.3.4.3ELA Medical42
    • 2.3.4.4Guidant42
    • 2.3.4.5Medtronic44
    • 2.3.4.6St. Jude Medical44
    • 2.3.4.7Defibrillators Growth Drivers44
    • 2.3.4.8Factors Limiting the Growth of Defibrillators44
  • 2.3.5Implantable Cardiac Rhythm Devices for Heart Failure44
  • 2.3.6External Products45
    • 2.3.6.1 Defibrillators45
    • 2.3.6.2Transesophageal Pacing46
  • 2.3.7 Product Innovations47
    • 2.3.7.1 Miniaturization47
    • 2.3.7.2 Modular Designs47
    • 2.3.7.3 New Products47
• 2.4 Patient Management48
• 2.5Regulatory Issues - Government Regulation48
  • 2.5.1U.S. Regulation48
    • 2.5.1.1Importing Medical Devices into the U.S.51
    • 2.5.1.2 Exporting Medical Devices from the U.S.52
  • 2.5.2 U.K. Regulation52
  • 2.5.3 EU Regulation54
  • 2.5.4 Japanese Regulation55
  • 2.5.5 Australian Regulation56
  • 2.5.6 Korea Regulation57
  • 2.5.7 India Regulation57
  • 2.5.8 Registration for Imported Medical Devices in China58
  • 2.5.9 Israel58
  • 2.5.10 The Philippines58
  • 2.5.11 Overseas Testing to Increase Time-to-Market58
• 2.6 Guidelines and Trade Organizations59
  • 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 Devices59
• 2.8 Worldwide Developments60
• 2.9 Reimbursement60
  • 2.9.1 U.S. Reimbursement60
    • 2.9.1.1Category "C" Codes61
    • 2.9.1.2 Medicare Decision on MADIT Reimbursements61
  • 2.9.2 European Reimbursement62
  • 2.9.3 Japanese Reimbursement62
• 2.10 Legal Proceedings63
• 2.11 Competition68
• 2.12 Strategic Corporate Developments69
  • 2.12.1 Acquisitions69
  • 2.12.2 Partnerships71
  • 2.13.3 Other Developments71
  • 2.13.4 Product Launches71
  
  
• 3.0The External Defibrillator Market74
• 3.1 Defibrillators Overview74
• 3.2External Automated Defibrillators74
• 3.3 Analysis of Major Competitors78


• 4.0 The Implantable Defibrillator Market83
• 4.1 Overview83
  • 4.1.1 Market Drivers for ICDs83
• 4.2 The Worldwide Market85
• 4.3 The U.S. Market86
• 4.4 Japanese Market87
• 4.5 Analysis of Major Competitors87
  • 4.5.1Biotronik89
  • 4.5.2Guidant Corporation89
  • 4.5.3Medtronic90
  • 4.5.4St. Jude Medical92
  • 4.5.5ELA Medical92
  • 4.5.6Japan Lifeline (JLL)93
  • 4.5.7Cardiac Rhythm Management93
  
  
• 5.0 The External Pacemakers Market94
• 5.1 Overview94
• 5.2 The U.S. Market94
• 5.3 The Worldwide Market95
• 5.4 Analysis of Major Competitors96
• 5.5 Transvenous External Pacemakers97
• 5.6Transvenous Pacemakers' Development97


• 6.0 The Implantable Pacemakers Market98
• 6.1 Overview98
• 6.2 The Worldwide Market98
• 6.3 The U.S. Market99
• 6.4 Analysis of Major Competitors101
• 6.5 Transvenous Temporary Pacemakers106


• 7.0Market Overview107
  • 7.1.1 Defibrillator and Pacemaker Lead/Electrode Markets107
  • 7.1.2Lead Extraction Market108
  • 7.1.3Electrode Tips and Rings108
• 7.2 The Worldwide Market108
• 7.3 The U.S. Market110
• 7.4 Analysis of Major Competitors111
  • 7.4.1 Cardiotronic112
  • 7.4.2 Guidant Corporation112
  • 7.4.3 Medtronic112
  • 7.4.4 St. Jude Medical113
  • 7.4.5 Zoll Medical115
  • 7.4.6 Biomec115
  • 7.4.7 ELA Medical115
  • 7.4.8 Sorin Biomedica115
  • 7.4.9 Biotronik115
  • 7.4.10 DR-ING P Osypka GmbH115
  • 7.4.11 CardioDynamics116
  
  
• 8.0 Heart Failure Products117
• 8.1 Overview117
• 8.2 Heart Failure Conditions118
• 8.3 Heart Failure Technology Platforms118
• 8.4 Patient Management through the Internet120


• 9.0 Company Profiles121
• 9.1 Cardiac Science Inc.121
• 9.2 Ballard Medical Products (Cardiotronic Systems Inc.) Kimberly-Clarke123
• 9.3 Guidant Corporation125
• 9.4 HeartBeat Medical Corporation129
• 9.5 Medtronic Inc.130
• 9.6 Pace Medical Inc.134
• 9.7 St. Jude Medical, Inc.137
• 9.8 Zoll Medical Corporation141
• 9.9 General Electric Corporation Medical Division144
• 9.10 Koninklijke Philips Electronics145
• 9.11 Thoratec Corporation147
• 9.12 Biomec Inc.151
• 9.13 ELA Medical151
• 9.14Sorin Biomedica/ELA153
• 9.15 Biotronik154
• 9.16 Japan Lifeline155
• 9.17 Cook Vascular Inc.155
• 9.18Emtel155
• 9.19 Heraeus156
• 9.20 Mayo Healthcare156
• 9.21 VascoMed, GmbH156
• 9.22 Oscor, GmbH158
• 9.23 CardioDynamics International Corp.159
• 9.24 Vermed160


• 10.0 Industry Trends161


• 11.0 Corporate Directory163

 

Appendix 1: Cardiac Rhythm CPT Codes for Medicare165

Appendix 2: New European Guideline for Defibrillator Implants166

Appendix 3: Cardiovascular Device Manufacturers Internet Links167

Appendix 4: Reimbursement CPT/APC Codes for Pacing Monitors171

Appendix 5: Frequently Asked Questions on Transesophageal Cardiology172

Appendix 6: Revision of Japanese Medical Device Approval Applications Classifications176

Appendix 7: Medical Device Regulatory Requirements for Australia178

Appendix 8: Regulation of Medical Devices in China183

Appendix 9: Chinese Laboratories Accredited by the State Drug Administration for Product Testing187

INDEX OF TABLES

Table 1: Worldwide Medical Manufacturing, 2002 - 201013

Table 2: U.S. Domestic Medical Device Exports (Except Ophthalmic) Annual, 1995 - 200014

Table 3: U.S. Medical Equipment (Except Ophthalmic) Imports for Consumption Annual, 1995 - 200015

Table 4: Surgical and Medical Instruments: U.S. Domestic Exports Annual, 1995 - 200016

Table 5: Surgical and Medical Supplies: U.S. Imports For Consumption Annual, 1995 - 200017

Table 6: Destinations of Canadian Medical Device Exports, 1998 - 200019

Table 7: Summary of the Total U.S. Defibrillator Market, 2001 and 200820

Table 8: Summary of the Total Worldwide Defibrillator Market, 2001 and 200820

Table 9: Summary of the Total U.S. Pacemaker Market, 2001 and 200820

Table 10: Summary of the Total Worldwide Pacemaker Market, 2001 and 200820

Table 11: Summary of the Total U.S. and Worldwide Defibrillator and Pacemaker Market, 2001 and 200821

Table 12: Estimated Number of Worldwide Patients with New Defibrillator or Pacemaker Implants, 200121

Table 13: Estimated Number of U.S. Patients with New Defibrillator and Pacemaker Implants, 200222

Table 14: Estimated Market Share of U.S. Defibrillator and Pacemaker Devices, 200122

Table 15: The U.S. Pacemaker and Defibrillator Market Size, 2001 - 200823

Table 16: Estimated Number of European Patients with New Defibrillator and Pacemaker Implants, 200223

Table 17: The European Pacemaker and Defibrillator Market23

Table 18: Estimated Number of New Defibrillator and Pacemaker Implants for Europe, 2001 - 200824

Table 19: Japanese Medical Equipment Market25

Table 20: Japanese Medical Equipment Market Estimated Import Market Share, 200226

Table 21: Japanese Implantable Device Market, 1994 - 200826

Table 22: Japanese Pacemaker and Defibrillator Market, 1994 - 200827

Table 23: Estimated Number of New Defibrillator and Pacemaker Implants for Japan, 2001 - 200427

Table 24: Country Medical Device Prices: Converted on the Purchasing-Power Parity Basis29

Table 25: Cardiac Management Activity Cost: Converted on the Purchasing-Power Parity Basis30

Table 26: Estimated Number of New Defibrillator and Pacemaker Implants for the Philippines, 2001 - 200430

Table 27: Estimated Number of New Defibrillator and Pacemaker Implants for Australia31

Table 28: Population and Physician Statistics for Countries with Medical Devices31

Table 29: Types of Defibrillators41

Table 30: New Technological Developments in the ICDs Market41

Table 31: External Defibrillators46

Table 32: Seven-Year Summary of Low Risk Device Applications and Review Times, 1995 - 200160

Table 33: Cardiac Rhythm Management Business, 2000-200269

Table 34: U.S. External Defibrillator Market, 1990-200875

Table 35: Estimated Worldwide External Defibrillator Market Share Standings, 200177

Table 36A: Worldwide External Defibrillator Market, 1990-200877

Table 36B: Royal Phillips Electronics U.S. External Defibrillator Home Market, 2000-200882

Table 36C: Market Drivers for ICDs83

Table 37: Worldwide Implantable Defibrillator Market, 2000-200885

Table 38: U.S. Implantable Defibrillator Market, 2000-200886

Table 39: Estimated U.S. ICD Manufacturer Market Share, 200287

Table 40: Estimated Worldwide ICD Manufacturer Market Share, 200287

Table 41: Estimated Worldwide ICD Manufacturer Market Share, 2000-200287

Table 42: ICD Share of the Cardiac Rhythm Management Business for Key Players89

Table 43: Estimated U.S. ICD Manufacturer Market Share, 2000-200289

Table 44: U.S. External Pacemaker Market, 1990-200895

Table 45: Worldwide External Pacemaker Manufacturer Market Share Standings, 200295

Table 46: Worldwide External Pacemaker Market, 1990-200896

Table 47: Worldwide Implantable Pacemaker Markets, 2000-200899

Table 48: Worldwide Implantable Pacemaker Manufacturer Market Share Standings, 200299

Table 49: U.S. Implantable Pacemaker Market, 2000-2008100

Table 50: U.S. Sales of Implantable Pacemakers by Device Type, 2002100

Table 51: U.S. Implantable Pacemaker Manufacturer Market Share Standings, 2002100

Table 52: U.S. Pacemaker Manufacturer Market Share, 2000-2002101

Table 53: Pacemaker Share of the Cardiac Rhythm Management Business for Key Players102

Table 54: U.S. Pacemaker Manufacturer Market Share, 2000-2002102

Table 55: Worldwide Defibrillator/Pacing Leads Market, 1990-2008109

Table 56: Worldwide External Defibrillator Electrode Market, 1990-2008109

Table 57: Worldwide External Defibrillator Electrode Manufacturer Market Share Standings, 2002110

Table 58: U.S. Defibrillator/Pacing Leads Market, 1990-2008110

Table 59: U.S. External Defibrillator Electrode Market, 1990-2008111

Table 60A: U.S. Defibrillator and Pacing Lead Manufacturer Market Share Standings, 2002111

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 Sales126

Table 62B: Guidant Business Unit Sales Share126

Table 63: Medtronic Five Year Sales Summary131

Table 64: Medtronic Consolidated Net Sales 2003131

Table 65: Medtronic Cardiac Rhythm Net Sales131

Table 66: St. Jude Medical Financials, 2002138

Table 67: St. Jude Sales by Division138

Table 68: St. Jude Medical Net Sales by Geographic Markets138

Table 69: St. Jude Cardiac Rhythm Net Sales139

Table 70: Japan Lifeline Ltd. Ownership155

Table 71: Vasco Pacing Leads157

INDEX OF FIGURES

Figure 1: Comparison of Global Medical Technology Markets19

Figure 2: Global Cardiac Rhythm Market21

Figure 3: Worldwide Implantable Defibrillator Market85

Figure 4: Worldwide ICD Manufacturer Market Share 200288

Figure 5: Cardiac Rhythm Management Business: 2000, 2001 and 200288

Figure 6: Medtronic Net Sales, 2001, 2002104

Figure 7: Cardiac Rhythm Management Net Sales132

Figure 8: Cardiac Impedance Cardiography Equipment Market Share by Location of Use160

Figure 9: Cardiac Sensors Market Share by Location of Usage160

 

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