Cardiac Rhythm Management (CRM) Devices

Table of Contents

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)

III. COMPETITIVE LANDSCAPE