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.
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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
2.2.2.3 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
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
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
Appendix 9: Chinese Laboratories Accredited by the State Drug Administration for Product Testing
