This 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.

1. Cardiac Rhythm Management Devices World Markets
Published: October 2011
No. of Pages: 250
Price: $ 3400
This 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 Executive Summary
1.1 Methodology
1.2 Overview of Report Objectives
2 Medical Device Market Overview
2.1.1 U.S. Medical Device Industry
2.1.2 China
2.1.3 Hong Kong
2.1.4 Taiwan
2.1.5 Singapore
2.1.6 Japan
2.1.7 Canadian Medical Device Market
2.1.8 European Medical Device Market
2.1.9 U.S. Cardiac Rhythm Management Market
2.1.10 European Market
2.1.11 Asian Market
2.1.11.1 Japanese Market Overview
2.1.11.2 Japanese Medical Practice
2.1.11.3 Japanese Distribution/Business Practices
2.1.11.4 Japanese Pricing
2.1.11.5 The Philippines Market
2.1.12 Australian Market
2.1.13 Middle Eastern Market
2.2 Cardiovascular Conditions Treated with Defibrillation and/or Pacing Devices
2.2.1 Cardiac Rhythm Management
2.2.2 Conditions Treated
2.2.2.1 Bradycardia
2.2.2.2 Tachyarrhythmia

2. 2.2.2.3 Heart Failure
2.2.2.4 Atrial Fibrillation
2.3 Principal Products
2.3.1 Implantable Cardiac Rhythm Devices for Bradycardia
2.3.1.1 Single-Chamber Pacemakers
2.3.1.1.1 Non-Rate Responsive Devices
2.3.1.1.2 Rate Responsive Devices
2.3.2 Dual-Chamber Pacemakers
2.3.3 Pacemakers by Manufacturer
2.3.3.1 ELA Medical (Sorin/Sina)
2.3.3.2 Guidant
2.3.3.3 Medtronic
2.3.3.4 St. Jude Medical
2.3.3.5 CCC Del Uruguay SA
2.3.3.6 Fiab Spa (Italy)
2.3.3.7 NeuroCor
2.3.3.8 Pace Medical Inc.
2.3.4 Implantable Cardiac Rhythm Devices for Tachycardia
2.3.4.1 Tachyarrhythmia Devices
2.3.4.2 Biotronik
2.3.4.3 ELA Medical
2.3.4.4 Guidant
2.3.4.5 Medtronic
2.3.4.6 St. Jude Medical
2.3.4.7 Defibrillators Growth Drivers
2.3.4.8 Factors Limiting the Growth of Defibrillators
2.3.5 Implantable Cardiac Rhythm Devices for Heart Failure
2.3.6 External Products
2.3.6.1 Defibrillators
2.3.6.2 Transesophageal Pacing
2.3.7 Product Innovations
2.3.7.1 Miniaturization
2.3.7.2 Modular Designs
2.3.7.3 New Products
2.4 Patient Management
2.5 Regulatory Issues - Government Regulation
2.5.1 U.S. Regulation
2.5.1.1 Importing Medical Devices into the U.S.
2.5.1.2 Exporting Medical Devices from the U.S.
2.5.2 U.K. Regulation
2.5.3 EU Regulation
2.5.4 Japanese Regulation
2.5.5 Australian Regulation
2.5.6 Korea Regulation
2.5.7 India Regulation
2.5.8 Registration for Imported Medical Devices in China
2.5.9 Israel
2.5.10 The Philippines
2.5.11 Overseas Testing to Increase Time-to-Market
2.6 Guidelines and Trade Organizations
2.6.1 American Heart Association (AHA)
2.6.2 Health Industry Manufacturers Association (HIMA)
2.7 Other Factors Influencing Cardiac Rhythm Management Devices

3. 2.8 Worldwide Developments
2.9 Reimbursement
2.9.1 U.S. Reimbursement
2.9.1.1 Category C Codes
2.9.1.2 Medicare Decision on MADIT Reimbursements
2.9.2 European Reimbursement
2.9.3 Japanese Reimbursement
2.10 Legal Proceedings
2.11 Competition
2.12 Strategic Corporate Developments
2.12.1 Acquisitions
2.12.2 Partnerships
2.12.3 Other Developments
2.12.4 Product Launches
3 The External Defibrillator Market
3.1 Defibrillators Overview
3.2 External Automated Defibrillators
3.3 Analysis of Major Competitors
4 The Implantable Defibrillator Market
4.1 Overview
4.1.1 Market Drivers for ICDs
4.2 The Worldwide Market
4.3 The U.S. Market
4.4 Japanese Market
4.5 Analysis of Major Competitors
4.5.1 Biotronik
4.5.2 Guidant Corporation
4.5.3 Medtronic
4.5.4 St. Jude Medical
4.5.5 ELA Medical
4.5.6 Japan Lifeline (JLL)
4.5.7 Cardiac Rhythm Management
5 The External Pacemakers Market
5.1 Overview
5.2 The U.S. Market
5.3 The Worldwide Market
5.4 Analysis of Major Competitors
5.5 Transvenous External Pacemakers
5.6 Transvenous Pacemakers' Development
6 The Implantable Pacemakers Market
6.1 Overview
6.2 The Worldwide Market
6.3 The U.S. Market
6.4 Analysis of Major Competitors
6.5 Transvenous Temporary Pacemakers
7 Market Overview
7.1
7.1.1 Defibrillator and Pacemaker Lead/Electrode Markets
7.1.2 Lead Extraction Market
7.1.3 Electrode Tips and Rings
7.2 The Worldwide Market
7.3 The U.S. Market
7.4 Analysis of Major Competitors

4. 7.4.1 Cardiotronic
7.4.2 Guidant Corporation
7.4.3 Medtronic
7.4.4 St. Jude Medical
7.4.5 Zoll Medical
7.4.6 Biomec
7.4.7 ELA Medical
7.4.8 Sorin Biomedica
7.4.9 Biotronik
7.4.10 DR-ING P Osypka GmbH
7.4.11 CardioDynamics
8 Heart Failure Products
8.1 Overview
8.2 Heart Failure Conditions
8.3 Heart Failure Technology Platforms
8.4 Patient Management through the Internet
9 Company Profiles
9.1 Cardiac Science Inc.
9.2 Ballard Medical Products (Cardiotronic Systems Inc.) Kimberly-Clarke
9.3 Guidant Corporation
9.4 HeartBeat Medical Corporation
9.5 Medtronic Inc.
9.6 Pace Medical Inc.
9.7 St. Jude Medical, Inc.
9.8 Zoll Medical Corporation
9.9 General Electric Corporation Medical Division
9.10 Koninklijke Philips Electronics
9.11 Thoratec Corporation
9.12 Biomec Inc.
9.13 ELA Medical
9.14 Sorin Biomedica/ELA
9.15 Biotronik
9.16 Japan Lifeline
9.17 Cook Vascular Inc.
9.18 Emtel
9.19 Heraeus
9.20 Mayo Healthcare
9.21 VascoMed, GmbH
9.22 Oscor, GmbH
9.23 CardioDynamics International Corp.
9.24 Vermed
10 Industry Trends
11 Corporate Directory
Appendices
Appendix 1: Cardiac Rhythm CPT Codes for Medicare
Appendix 2: New European Guideline for Defibrillator Implants
Appendix 3: Cardiovascular Device Manufacturers Internet Links
Appendix 4: Reimbursement CPT/APC Codes for Pacing Monitors
Appendix 5: Frequently Asked Questions on Transesophageal Cardiology
Appendix 6: Revision of Japanese Medical Device Approval Applications Classifications
Appendix 7: Medical Device Regulatory Requirements for Australia
Appendix 8: Regulation of Medical Devices in China

5. Appendix 9: Chinese Laboratories Accredited by the State Drug Administration for Product
Testing
List Of Tables
Table 1: Worldwide Medical Manufacturing, 2002 - 2010
Table 2: U.S. Domestic Medical Device Exports (Except Ophthalmic) Annual, 1995 - 2000
Table 3: U.S. Medical Equipment (Except Ophthalmic) Imports for Consumption Annual,
1995 - 2000
Table 4: Surgical and Medical Instruments: U.S. Domestic Exports Annual, 1995 - 2000
Table 5: Surgical and Medical Supplies: U.S. Imports For Consumption Annual, 1995 -
2000
Table 6: Destinations of Canadian Medical Device Exports, 1998 - 2000
Table 7: Summary of the Total U.S. Defibrillator Market, 2001 and 2008
Table 8: Summary of the Total Worldwide Defibrillator Market, 2001 and 2008
Table 9: Summary of the Total U.S. Pacemaker Market, 2001 and 2008
Table 10: Summary of the Total Worldwide Pacemaker Market, 2001 and 2008
Table 11: Summary of the Total U.S. and Worldwide Defibrillator and Pacemaker Market,
2001 and 2008
Table 12: Estimated Number of Worldwide Patients with New Defibrillator or Pacemaker
Implants, 2001
Table 13: Estimated Number of U.S. Patients with New Defibrillator and Pacemaker
Implants, 2002
Table 14: Estimated Market Share of U.S. Defibrillator and Pacemaker Devices, 2001
Table 15: The U.S. Pacemaker and Defibrillator Market Size, 2001 - 2008
Table 16: Estimated Number of European Patients with New Defibrillator and Pacemaker
Implants, 2002
Table 17: The European Pacemaker and Defibrillator Market
Table 18: Estimated Number of New Defibrillator and Pacemaker Implants for Europe,
2001 - 2008
Table 19: Japanese Medical Equipment Market
Table 20: Japanese Medical Equipment Market Estimated Import Market Share, 2002
Table 21: Japanese Implantable Device Market, 1994 - 2008
Table 22: Japanese Pacemaker and Defibrillator Market, 1994 - 2008
Table 23: Estimated Number of New Defibrillator and Pacemaker Implants for Japan, 2001
- 2004
Table 24: Country Medical Device Prices: Converted on the Purchasing-Power Parity Basis
Table 25: Cardiac Management Activity Cost: Converted on the Purchasing-Power Parity
Basis
Table 26: Estimated Number of New Defibrillator and Pacemaker Implants for the
Philippines, 2001 - 2004
Table 27: Estimated Number of New Defibrillator and Pacemaker Implants for Australia
Table 28: Population and Physician Statistics for Countries with Medical Devices
Table 29: Types of Defibrillators
Table 30: New Technological Developments in the ICDs Market
Table 31: External Defibrillators
Table 32: Seven-Year Summary of Low Risk Device Applications and Review Times, 1995 -
2001
Table 33: Cardiac Rhythm Management Business, 2000-2002
Table 34: U.S. External Defibrillator Market, 1990-2008
Table 35: Estimated Worldwide External Defibrillator Market Share Standings, 2001
Table 36A: Worldwide External Defibrillator Market, 1990-2008
Table 36B: Royal Phillips Electronics U.S. External Defibrillator Home Market, 2000-2008
Table 36C: Market Drivers for ICDs
Table 37: Worldwide Implantable Defibrillator Market, 2000-2008

6. Table 38: U.S. Implantable Defibrillator Market, 2000-2008
Table 39: Estimated U.S. ICD Manufacturer Market Share, 2002
Table 40: Estimated Worldwide ICD Manufacturer Market Share, 2002
Table 41: Estimated Worldwide ICD Manufacturer Market Share, 2000-2002
Table 42: ICD Share of the Cardiac Rhythm Management Business for Key Players
Table 43: Estimated U.S. ICD Manufacturer Market Share, 2000-2002
Table 44: U.S. External Pacemaker Market, 1990-2008
Table 45: Worldwide External Pacemaker Manufacturer Market Share Standings, 2002
Table 46: Worldwide External Pacemaker Market, 1990-2008
Table 47: Worldwide Implantable Pacemaker Markets, 2000-2008
Table 48: Worldwide Implantable Pacemaker Manufacturer Market Share Standings, 2002
Table 49: U.S. Implantable Pacemaker Market, 2000-2008
Table 50: U.S. Sales of Implantable Pacemakers by Device Type, 2002
Table 51: U.S. Implantable Pacemaker Manufacturer Market Share Standings, 2002
Table 52: U.S. Pacemaker Manufacturer Market Share, 2000-2002
Table 53: Pacemaker Share of the Cardiac Rhythm Management Business for Key Players
Table 54: U.S. Pacemaker Manufacturer Market Share, 2000-2002
Table 55: Worldwide Defibrillator/Pacing Leads Market, 1990-2008
Table 56: Worldwide External Defibrillator Electrode Market, 1990-2008
Table 57: Worldwide External Defibrillator Electrode Manufacturer Market Share Standings,
2002
Table 58: U.S. Defibrillator/Pacing Leads Market, 1990-2008
Table 59: U.S. External Defibrillator Electrode Market, 1990-2008
Table 60A: U.S. Defibrillator and Pacing Lead Manufacturer Market Share Standings, 2002
Table 60B: AV Nodal Ablation Procedures for AF in the U.S.
Table 61: Guidant Financials ($ Thousands)
Table 62A: Guidant Cardiac Rhythm Net Sales
Table 62B: Guidant Business Unit Sales Share
Table 63: Medtronic Five Year Sales Summary
Table 64: Medtronic Consolidated Net Sales 2003
Table 65: Medtronic Cardiac Rhythm Net Sales
Table 66: St. Jude Medical Financials, 2002
Table 67: St. Jude Sales by Division
Table 68: St. Jude Medical Net Sales by Geographic Markets
Table 69: St. Jude Cardiac Rhythm Net Sales
Table 70: Japan Lifeline Ltd. Ownership
Table 71: Vasco Pacing Leads
List Of Figures
Figure 1: Comparison of Global Medical Technology Markets
Figure 2: Global Cardiac Rhythm Market
Figure 3: Worldwide Implantable Defibrillator Market
Figure 4: Worldwide ICD Manufacturer Market Share 2002
Figure 5: Cardiac Rhythm Management Business: 2000, 2001 and 2002
Figure 6: Medtronic Net Sales, 2001, 2002
Figure 7: Cardiac Rhythm Management Net Sales
Figure 8: Cardiac Impedance Cardiography Equipment Market Share by Location of Use
Figure 9: Cardiac Sensors Market Share by Location of Usage
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