This report analyzes the worldwide markets for Cardiac Rhythm Management (CRM) Devices in Millions of US$ by the following segments: Implantable Cardioverter Defibrillators (ICD), Pacemakers, External Defibrillators, and EP Catheterization, Mapping, and Ablation (CMA) devices.The report provides separate comprehensive analytics for the United States, and Rest of World. Annual forecasts are provided for each region for the period 2006 through 2015. A six-year historic analysis is also provided for these markets. The report profiles 59 companies including many key and niche players worldwide such as Bard Electrophysiology, Biosense Webster, Inc., Boston Scientific Corporation, Biotronik GMBH & Co. KG, Medtronic, Inc., Medtronic CryoCath LP, Vitatron Nederland BV, Philips Healthcare, St. Jude Medical, Inc., and Sorin Group. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
Implantable Cardioverter Defibrillators (ICD)
Pacemaker
External Defibrillators
Electrophysiology (EP) Catheterization, Mapping, and Ablation (CMA)

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW

A Prelude
Market Structure
Table 1: World Market for Cardiac Rhythm Management Devices (2008 & 2010P): Percentage Market Share Breakdown of Leading Players - Medtronic, St. Jude Medical, Boston Scientific (Guidant), and Others (includes corresponding Graph/Chart)
Table 2: World Market for High Power CRM Devices (2008 & 2010P): Percentage Market Share Breakdown of Leading Players Medtronic, St. Jude Medical, Boston Scientific (Guidant), and Others (includes corresponding Graph/Chart)
Table 3: World Market for Low Power CRM Devices (2008 & 2010P): Percentage Market Share Breakdown of Leading Players - Medtronic, St. Jude Medical, Boston Scientific (Guidant), and Others (includes corresponding Graph/Chart)
Table 4: World Market for Implantable Cardioverter Defibrillator (ICD) (2008 & 2010P): Percentage Market Share Breakdown of Leading Players - Medtronic, Boston Scientific (Guidant), St. Jude Medical, and Others (includes corresponding Graph/Chart)
Table 5: World Catheter Ablation Devices Market (2007): Percentage Market Share Breakdown of Leading Players - Johnson & Johnson, St.Jude Medical, Boston Scientific, Bard, Medtronic, CryoCath, and Others (includes corresponding Graph/Chart)
Table 6: World External Defibrillators Market (2006): Percentage Market Share Breakdown of Leading Players - Medtronic, Philips and Others (includes corresponding Graph/Chart)
Table 7: World Market for Advanced Cardiac Resynchronization Therapy (CRT) Devices (2005): Percentage Market Share Breakdown of Leading Players - Medtronic, Boston Scientific (Guidant), St. Jude Medical, and Others (includes corresponding Graph/Chart)
Noteworthy Trends & Issues
Infamous Product Recalls Throw Growth Off-track
Market Shapes Up After the Recall Shock
Regulatory Riders Knit to Ensure Greater Device Reliability
Growing Proportion of Obese Population: A Major Demographic Driver
Replacements to Drive the Growth of ICDs
Developments in Energy-Based Therapies Augur Well for Cardiac Ablation Treatments
Expanding Applications Lend Traction to Growth
Prices of Cardiac Pacemakers Soften
Heart Patients Using ICD, Enjoy Satisfactory Quality Life
Pacemakers Ensure Effective Management of Non-Systolic Heart Failures
CRT: An Effective Treatment for Bradycardia, Tachycardia & Fibrillation
ICDs in Pediatric Care Shows Promise
Emerging Therapies for the Treatment of Atrial Fibrillation
New Generation CRM Devices Feature Superior Benefits
MRI-Compatible Pacemakers & ICDs
Resistance Against Electronic Interferences
Confusion Over the Use of CRM Devices Threaten Perceived Effectiveness
Breathing Disorders in Patients Implanted with Pacemakers: A Cause for Concern
Approval of Untested Pacemaker Connectors Raises Eyebrows
ICD Lead Failure Demands Immediate Attention
Pacemaker Hacking Has the Industry Up by Its Ears
Pacemakers Face Stiff Competition from CRT-D Devices
ICDs More Prone to Malfunction than Pacemakers
Conclusion
Technology Innovation: A Futuristic Rumination
The Heart to Power CRM Devices: The Future of CRM Therapies
Genetic Advances to Yield Replacement for Pacemakers
Ablation Technology Undergoing Innovations
Vein Ablation Catheter Proves Successful in Cases of Paroxysmal Atrial Fibrillation
Ablation Therapy Useful in Treating Persistent/ Permanent Atrial Fibrillation (PPAF)
Magnetic Navigation: An Innovation in Catheter Ablation
New Force-Sensing Ablation Catheter Aims to Aid Physician Decision Making
Pricing & Reimbursements: Critical Determinants of Growth
New Guidelines Issued for Safe Management of CRM Devices in the US and Europe

2. REGIONAL MARKET OVERVIEW

2a. THE UNITED STATES

A. Market Analysis
Outlook
Market Overview
Demand for Automated External Defibrillators Shoots Up in the US
Market Share Statistics
Table 8: US Market for Implantable Cardioverter Defibrillator (ICD) (2007& 2010): Percentage Breakdown of Player Market Shares - Medtronic, Boston Scientific (Guidant), St Jude Medical, and Others (includes corresponding Graph/Chart)
Table 9: US Market for Core Pacemakers & CRT-P (2007 & 2010): Percentage Breakdown of Player Market Shares - Medtronic, St. Jude, Boston Scientific, and Others (includes corresponding Graph/Chart)
Cardiovascular Disease Incidence Statistics
Table 10: Total Direct Economic Cost of Cardiovascular Diseases (CVDs) in the United States (2009E): Breakdown by Disease Type (In US$ Billion) (includes corresponding Graph/Chart)
Table 11: Total Direct Economic Cost of Cardiovascular Diseases (CVDs) in the United States (2009E): Percentage Breakdown by Type of Expenditure (includes corresponding Graph/Chart)
Table 12: Prevalence of Cardiovascular Diseases in Adults Over the Age of 20 Years in the United States (2006): Percentage Breakdown by Age and Gender (includes corresponding Graph/Chart)
Table 13: Cardiovascular Diseases in the United States (2006): Percentage Breakdown of Deaths Caused by Cardiovascular Diseases by Type (includes corresponding Graph/Chart)
B. Market Analytics
Table 14: US Recent Past, Current & Future Analysis for Cardiac Rhythm Management Devices by Product Segment - Implantable Cardioverter Defibrillators, Pacemakers, External Defibrillators, and EP Catheterization, Mapping, and Ablation (CMA) Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
Table 15: US Historic Review for Cardiac Rhythm Management Devices by Product Segment - Implantable Cardioverter Defibrillators, Pacemakers, External Defibrillators, and EP Catheterization, Mapping, and Ablation (CMA) Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2005 (includes corresponding Graph/Chart)
Table 16: US 10-Year Perspective for Cardiac Rhythm Management Devices by Product Segment - Percentage Breakdown of Dollar Sales for Implantable Cardioverter Defibrillators, Pacemakers, External Defibrillators, and EP Catheterization, Mapping, and Ablation (CMA) for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)

2b. REST OF WORLD

A. Market Analysis
Outlook
Market Share Statistics
Table 17: Implantable Cardioverter Defibrillator (ICD) Market in EMEA, Asia, & South America (2007&2010): Percentage Market Share Breakdown of Leading Players - Medtronic, Boston Scientific (Guidant), St Jude Medical, and Others (includes corresponding Graph/Chart)
Table 18: Core Pacemakers & CRT-P Market in EMEA, Asia, & South America (2007&2010): Percentage Market Share Breakdown of Leading Players - Medtronic, St. Jude, Boston Scientific and Others (includes corresponding Graph/Chart)
Focus on Select Markets
Europe
Highly Competitive External Defibrillators Market Paves Way for Consolidations
UK
Asia-Pacific
China
B. Market Analytics
Table 19: Rest of World Recent Past, Current & Future Analysis for Cardiac Rhythm Management Devices by Product Segment - Implantable Cardioverter Defibrillators, Pacemakers, External Defibrillators, and EP Catheterization, Mapping, and Ablation (CMA) Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
Table 20: Rest of World Historic Review for Cardiac Rhythm Management Devices by Product Segment - Implantable Cardioverter Defibrillators, Pacemakers, External Defibrillators, and EP Catheterization, Mapping, and Ablation (CMA) Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2005 (includes corresponding Graph/Chart)
Table 21: Rest of World 10-Year Perspective for Cardiac Rhythm Management Devices by Product Segment - Percentage Breakdown of Dollar Sales for Implantable Cardioverter Defibrillators, Pacemakers, External Defibrillators, and EP Catheterization, Mapping, and Ablation (CMA) for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)

3. PRODUCT OVERVIEW

Sudden Cardiac Arrest: A Leading Cause of Death
Cardiac Rhythm Management (CRM): A Definition
Implantable Cardioverter Defibrillators (ICDs)
Surgical Implantation of ICDs: The Procedure
ICDs - The Benefits
Types of ICDs
ICDs: An Evolution Scan
Complications Associated With ICD Usage
CRT-D - A New Therapeutic Device
Pacemakers
Surgical Implantation of Pacemakers: The Procedure
Types of Pacemakers
Methods of Pacing
Fixed Rate Pacemakers
Demand Pacemakers
Rate-Responsive Pacemaker
Pacemakers: An Evolution Scan
Complications Associated with Pacemakers
Advent of CRT-P
Electrophysiology (EP) Catheterization, Mapping, and Ablation (CMA)
The Ablation Procedure
External Defibrillators
Types of AEDs
Cardiac Rhythm Disorders: A Brief Review
Cardiac Arrhythmias
Classification of Cardiac Arrhythmias
Bradycardia
Tachycardia
Atrial Fibrillation
Heart Blocks
Syncope
Sick Sinus Syndrome
Cardiomyopathy

4. PRODUCT APPROVALS/INTRODUCTIONS

Biosense Catheter Receives FDA Marketing Approval
St. Jude Medical Secures Approval for Atlas II ICD from Japan
Zoll Medical Defibrillators Receive FDA Clearance
St. Jude Medical Receives CE Mark for Integrated Irrigation Pump and Ablation Generator
AtriCure Secures FDA 510(k) Approval for Coolrail Device
Hansen Medical Gains FDA Approval for CoHesion(tm) Module
St. Jude Medical Obtains CE Mark and FDA Approval for HIFU Surgical Ablation Solutions
Biosense Releases NAVISTAR(r) RMT THERMOCOOL(r) Catheter
Atricure Unveils The ORLab(tm)
Cardima Receives SFDA Approval to Market INTELLITEMP(r) in China
ZOLL Obtains 510K Clearance to Sell and Market Zoll R Series Code-Ready Defibrillator
ST. Jude Medical Obtains FDA and CE Mark Approval for New Epicor LP Cardiac Ablation System
Cardima Obtains Approval for Marketing Surgical Ablation System in Thailand
ATS Medical Introduces First CryoMaze Surgical Ablation Clamp
CardioNet Unveils New Reporting Package for Atrial Fibrillation Treatment
Boston Scientific Defibrillator Receives CE Mark Approval
TyRx Introduces New Anti-bacterial Envelope, AIGISRX(tm) ICD
St. Jude Medical Receives Approval from Japanese MHLW
Boston Scientific Secures FDA Approval for CRM Solutions
Sorin Group Develops New-Generation CRT-D Implants
BSC Secures CE Mark Approval for ALTRUA Pacemakers
Medtronic Secures FDA Approval for New Vision 3D Devices
Medtronic Obtains FDA Approval for Software Update
St. Jude Medical Obtains FDA Approval for SJM Cardiac Monitor
Boston Scientific Obtains Approval For Cognis CRT-D And Teligen ICD
FDA Approves Medtronic' s Medtronic Sprint Quattro Secure(r) S Lead
Medtronic Obtains CE Mark Approval for Pacemaker and Pacing Leads
St. Jude Medical Obtains Japanese Approval for Victory(r) Pacemakers Family
Sorin Group Obtains Approval For Isoline Defibrillation Leads In Japan
BSC Secures FDA Approval for New ALTRUA Pacemakers
St. Jude Medical Obtains Approval for Durata Defibrillation Lead
St. Jude Medical Obtains Japanese Approval for Durata Defibrillation Lead
St. Jude Medical Obtains Japanese Approval for Victory Family of Pacemakers
Sorin Group Gains FDA Approval for OVATIO(tm)
Sorin SpA Gains FDA Approval for REPLY
Medtronic Receives Approval for Lead Integrity Alert(tm)
Physio-Control Gains FDA Approval for LIFEPAK(r) 20e Defibrillator/Monitor
TyRx Introduces New Anti-Bacterial Envelope, AIGISRX(tm) ICD
LifeWatch Introduces Next-Generation Monitor, LifeStar ACT III Platinum
eCardio Launches eVolution, New Cardiac Monitoring System
Philips Introduces PageWriter TC70 Cardiograph
Sorin Group Announces Commercial Release and First Implant of PARADYM(tm) CRT 8750
St. Jude Medical Introduces QuickOpt(r) Timing Cycle Optimization in CRT-D
Cardiac Science Unveils Simple Electronic Reporting System
Mennen Medical Introduces VitaLogik(r) 4000 Line
BIOTRONIK Releases CRT-P in US Market
Vermed Releases Defibrillation Pads Series and Universal Connector System
St. Jude Releases Reflexion Spiral X(tm) in US
St. Jude Introduces Therapy Cool Path
Ablation Frontiers Obtains CE Marks and Commercially Launches Cardiac Ablation System
Isolator(r) Bipolar Ablation Clamp System of AtriCure Obtains FDA 510(k) Clearance
Hansen Medical Receives CE Mark Approval for Sensei Robotic Catheter System and Artisan Control Catheter
ZOLL AED Pro Secures FDA Approval for Use with See-Thru CPR(tm) Technology
European Approval for CardioFocus' s Endoscopic Ablation System
Leipzig' s Heart Centre Unveils New Catheter Ablation Solution
CardioFocus Receives CE Mark for Endoscopic Ablation System
FDA Approves SOLAR(tm) Surgical Ablation System of MedicalCV
Cardima Launches Cardima Surgical Ablation Probe with 24 Electrodes
Stereotaxis Receives Approval from FDA for a 8mm Ablation Catheter
Japan Approves Sprint Quattro(tm) of Medtronic
Boston Scientific Receives European Clearance for CONFIENT(tm) ICD
St. Jude Receives Japanese Approval for CRT-D Systems
St. Jude Receives CE Mark and FDA Approval for QuickOpt(tm)
Hansen Medical Unveils Sensei(tm) Robotic Catheter System
St. Jude Medical Receives FDA Approval for Two Devices
St. Jude Medical Obtains European CE Mark Clearance for Cardiac Devices
St. Jude Medical Receives Approval for Pacemaker in the US and UK
Boston Scientific Receives FDA Approval for ACUITY(r) Steerable Lead
St. Jude Medical Receives FDA Approval for its New CRM Device
The Sorin Group Receives CE Mark for Its New Reply(tm) Pacemakers
St. Jude Medical Receives FDA Approval for Merlin.net Patient Care Network
Europe Approves Implantable Cardiac Rhythm Appliance of Boston Scientific
CE Mark and FDA Approve Zephyr(tm) Pacemaker of St. Jude
FDA Gives Clearance for Atlas II+ HF CRT-D of St. Jude
St Jude Medical Receives Approval from Japan
Sorin Launches REPLY Following CE Mark Certification
BIOTRONIK Launches Lumax 340 VR-T XL ICD
Medtronic to Launch Medtronic CareLink Network in EU
St. Jude Medical Receives Approval for Using CRT-D Systems in Japan
St. Jude Medical Receives FDA Approval for Promote CRT-D and Current ICD
Bio-Detek Receives FDA Approval for PocketCPR(tm)
EZ STEER Bi-Directional Catheter for Treating Abnormal Cardiac Rhythms
Philips Unveils EP Navigator Tool for Complex Cardiac Arrhythmias
Medtronic Launches Advanced Cardiac Defibrillators with Wireless Feature
Sorin Group Introduces OVATIO Implantable Cardioverter Defibrillators

5. RECENT INDUSTRY ACTIVITY

Medtronic Takes Over Ablation Frontiers
Philips Signs a Deal with Bard Electrophysiology
Boston Scientific Bags CRM Contract from Dept. of Veterans Affairs
Medtronic and Boston Scientific Inks Agreement to End IP Disputes
St Jude Medical to Invest in Penang
Cardima Enters into a Distribution Agreement with Peerless Medical
Cardiac Science Enters into an Alliance with Boy Scouts of America
Cardima Enters into a New Strategic Surgical Alliance with Biocore
Cardima Enters into a New Strategic Marketing Alliance with On-X Life Technologies
Welch Allyn and ZOLL Medical Corporation Collaborate
Cardima Selects Dot Medical to Distribute Its EP Products in the UK
Royal Philips to Guide ' euHeart' Project
Target Center Acquires HeartSine(r) Defibrillators
St Jude Medical Acquires EP MedSystems
St. Jude Takes Over Radi Medical AB
Medrad to Acquire Possis
Phoenix Acquires Stake in Possis
Biotronik Acquires VascoMed
Medtronic Takes Over CryoCath Technologies
Boston Scientific Takes Over CryoCor
St. Jude Completes Acquisition of MediGuide
Greatbatch Enters Into A Strategic Partnership With Issys
Sorin Group Inks Collaborative Agreement with Greatbatch
Philips Enters into MOU with King' s College London on Research Collaboration
Welch Allyn Collaborates with ZOLL Medical Corporation
ZOLL and HealthTrust Sign Purchasing Deal
ZOLL Inks Multi-Year Agreement with Masimo
First Responder Wins Contract from Harvard School of Public Health
Beijing Airport Group to Deploy ZOLL AED Plus Solutions
STH NHS Trust to Deploy New R Series BLS Solutions of ZOLL
Major EMS Centers in China Deploys ZOLL M Series Defibrillator
DRF to Deploy corpuls3 Heart Defibrillators
Riedel & Schulz and GS Elektromed Distributes 8 corpuls3 Medical Units
Trivitron Inks Marketing And Distribution Agreement With Boston Scientific
CardioComm Signs Licensing Agreement with GE Healthcare
Cambridge Heart Licenses Technology for Implantable Devices
Synovis Life Technologies to Divest Interventional Business
Boston Scientific Divests Cardiac Surgery And Vascular Surgery Businesses
Sorin Group Sells Its Vascular Therapy Business to CIDl
Medtronic and Biosense Webster Enter Into Alliance for Advance Cardiac Ablation
ATS Medical Takes Over Surgical Ablation Business of CryoCath
Biosense Webster Enters into a Strategic Alliance with Medtronic
Atricure Takes Over Frigitronics(r) Cryogenic Product Series
Boston Scientific Announces Approval and Launch of VITALITY(tm) DR ICD
Boston Scientific to Reallocate Resources for R&D in CRM
Vicor Technologies Merges with SRKP 6
Greatbatch Takes Over Biomec
Greatbatch Completes Quan Emerteq Acquisition
Greatbatch Takes Over Enpath Medical
Medtronic to Take Over MRI Safety Patents of Biophan
Teleflex Takes Over Arrow
Edwards Acquires CardioVations Division
Boston Scientific Inks Deal to Take Over Remon Medical Technologies
Sorin and Japan Lifeline Sign Ten-Year CRM Partnership
Royal Philips Joins Hands with Healthcare Entities
Triple Ring Forms Partnership with Aubrey
SurModics and St. Jude Medical Sign Corporate Technology Agreement
Siemens Medical Solutions Extends Strategic Alliance with Biosense Webster
Hansen and St. Jude Enter into Agreements
St. Jude Medical Secures a Cardiac Rhythm Management Devices Contract
Biotronik Secures Cardiac Rhythm Management Contract from Premier
ZOLL Selected to Supply Emergency Preparedness Equipment
Edwards Lifesciences Announces Multi-Year Grant to University of California
St. Jude Medical Announced Plans to Expand Operations in Puerto Rico
Biophan to Make Investment in Myotech

6. FOCUS ON SELECT PLAYERS

Bard Electrophysiology (USA)
Biosense Webster, Inc. (USA)
Boston Scientific Corporation (USA)
Biotronik GMBH & Co. KG (Germany)
Medtronic, Inc. (USA)
Medtronic CryoCath LP (USA)
Vitatron Nederland BV (Netherlands)
Philips Healthcare (The Netherlands)
St. Jude Medical, Inc. (USA)
Sorin Group (Italy)

7. GLOBAL MARKET PERSPECTIVE

Table 22: World Recent Past, Current & Future Analysis for Cardiac Rhythm Management Devices by Geographic Region - United States and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
Table 23: World Historic Review for Cardiac Rhythm Management Devices by Geographic Region - United States and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2005 (includes corresponding Graph/Chart)
Table 24: World 10-Year Perspective for Cardiac Rhythm Management Devices by Geographic Region - Percentage Breakdown of Dollar Sales for United States and Rest of World for Years 2006, 2009 & 2015
Table 25: World Recent Past, Current & Future Analysis for Cardiac Rhythm Management Devices by Product Segment - Implantable Cardioverter Defibrillators, Pacemakers, External Defibrillators, and EP Catheterization, Mapping, and Ablation (CMA) Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
Table 26: World Historic Review for Cardiac Rhythm Management Devices by Product Segment - Implantable Cardiac Defibrillators, Pacemakers, External Defibrillators, and EP Catheterization, Mapping, and Ablation (CMA) Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2005 (includes corresponding Graph/Chart)
Table 27: World 10-Year Perspective for Cardiac Rhythm Management Devices by Product Segment - Percentage Breakdown of Dollar Sales for Implantable Cardioverter Defibrillators, Pacemakers, External Defibrillators, and EP Catheterization, Mapping, and Ablation (CMA) for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)

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Cardiac Rhythm Management (CRM) Devices

Introduction

Abstract

Table of Contents