Contents:

1. Overview 1.1 Scope of This Report 1.2 Methodology 1.3 Executive Summary 2. Cardiac Rhythm Management: An Overview 2.1 Cardiac Rhythm Disorders 2.1.1 Premature Atrial Contractions (PACs) Sinus Tachycardia 2.1.2 Sinus Tachycardia 2.1.3 Sinus Bradycardia 2.2 Abnormal Rhythms 2.2.1 Tachycardia Ventricular Fibrillation (V Fib) 2.2.2 Ventricular Fibrillation (V Fib) 2.2.3 Ventricular Flutter 2.2.4 Paraxysmal Supraventricular Tachycardia (PSVT) 2.2.5 Atrial Fibrillation (A Fib) 2.3 Causes of Heart Rhythm Disorders 2.3.1 Symptoms of Heart Rhythm Disorders, Exams and Tests 2.3.1.1 Treatment for Heart Rhythm Disorders 2.4 Sudden Cardiac Death (SCD) 2.4.1 Incidence of SCD in the U.S. 2.5 Cardiac Rhythm Management Devices: An Overview 2.5.1 Cardiac Pacemakers 2.5.1.1 NBG Codes for Permanent Pacing 2.5.2 Pacemaker Components 2.5.2.1 Batteries in Pacemakers 2.5.2.2 Circuitry in Pacemakers 2.5.2.3 Connector Blocks of Pacemakers 2.5.2.4 Leads in Pacemakers 2.5.2.5 Electrodes in Pacemakers 2.5.2.6 Insulation in Pacemakers 2.5.2.7 Conductor Coils in Pacemakers 2.5.2.8 Fixation Mechanisms 2.5.2.9 Connectors in Pacemakers 2.5.2.10 Unipolar and Bipolar Pacing Systems 2.6 Basic Concepts and Terms in Pacemaker Procedures 2.6.1 Pacing Threshold 2.6.2 Sensing of Pacemakers 2.6.3 Slew Rate 2.6.4 Impedance in Pacing 2.6.5 Acute Implant Values in Pacing 2.6.6 Post-Implant Values 2.6.7 Pacing Intervals 2.6.8 Programmability 2.6.9 Magnetic Response in Pacing 2.7 Basic Single Chamber Pacing 2.7.1 Automatic Interval in Basic Single Chamber Pacing 2.7.2 Escape Interval 2.7.3 Refractory Period 2.8 Additional Concepts in Single Chamber Pacing 2.8.1 Hysteresis 2.8.2 Fusion and Pseudofusion in Single Chamber Pacing 2.8.3 Latency in Single Chamber Pacing 2.9 Concepts and Modes in Dual Chamber Pacing 2.9.1 AV Interval (AVI) 2.9.2 Differential AV Interval 2.9.3 Adaptive AVI 2.9.4 Atrial Escape Interval (AEI) 2.9.5 Post-Ventricular Atrial Refractory Period (PVARP) 2.9.6 Total Atrial Refractory Period (TARP) 2.9.7 Adaptive PVARP 2.9.8 Upper Rate Limit (URL) 2.9.9 Ventricular Blanking Period 2.9.10 Atrial-based Timing 2.9.11 DDD Mode 2.9.12 Totally Inhibited (PR) Pacing 2.9.13 Atrial Pace/Ventricular Inhibited (AR) 2.9.14 Atrial Inhibited Ventricular Pacing (PV) 2.9.15 Atrial Paced and Ventricular Paced (AV) 2.9.16 DVI Pacing 2.9.17 DDI Mode 2.9.18 VDD Mode 2.9.19 Upper Rate Behavior 2.9.20 Block (Multiblock) 2.9.21 Pseudo-Wenckebach 2.9.22 Rate Smoothing 2.9.23 Fallback Response 2.9.24 Sensor-driven Rate Smoothing 2.9.25 Sensor-driven Pacing in Dual Chamber Pacemakers 2.9.26 Activity/Vibration 2.10 Tips for Buying Cardiac Pacemakers 2.10.1 Comparison of Biotronik’s Cardiac Pacemakers 2.10.2 Comparison of Cardiac Pacemakers from Boston Scientific 2.10.3 Comparison of Cardiac Pacemakers from Medtronic 2.11 Implantable Cardioverter-Defibrillators (ICDs) 2.11.1 NBD Code for ICD 2.11.2 Basic Concepts of ICDs 2.11.3 Battery in ICDs 2.11.4 Capacitors in ICDs 2.11.5 Sensing in ICDs 2.11.6 Detection in ICDs 2.11.7 Defibrillation Waveform 2.11.8 Defibrillation Threshold 2.11.9 Anti Tachycardia Pacing (ATP) 2.12 Recommended Replacement Time for ICDs 2.13 Cardiac Resynchronization Therapy (CRT) 2.13.1 Clinical Benefits of CRT in Atrial Fibrillation 2.13.2 Differences between Pacemaker and CRT Device 2.13.3 CRT-P Implantation 2.13.4 CRT-D Implantation 2.13.5 CRT-D Implantation Procedure 2.14 Insertable Loop Recorder (ILR) 2.14.1 Implantation of ILR 2.15 External Cardioverter-Defibrillators 2.15.1 Types of Automatic External Defibrillators (AEDs) 2.15.2 External Defibrillation Procedure 2.15.3 Accuracy of an AED 2.15.4 Battery Core and Maintenance of an AED 2.15.5 Purchase Considerations for AEDs 2.16 Wearable Cardioverter-Defibrillators 2.17 Devices Interfering with Cardiac Implants 2.18 Future Applications for Pacemakers 2.19 Device Life of CRM Implants 2.20 Quality of Life with CRM Implants 2.21 Cost of CRM Implants 3. Market Analysis for CRM Products 3.1 Global Cardiac Devices Market 3.1.1 North American Market for Cardiac Medical Devices 3.1.2 European Market for Cardiac Medical Devices 3.1.3 Cardiac Medical Devices Market in Asia-Pacific 3.1.4 Global market for Interventional Cardiac Devices 3.1.5 Global Market for Peripheral Vascular Devices 3.1.6 Global Peripheral Vascular Device Market by Vendor 3.1.7 Global market for Cardiac Electrophysiology Market 3.1.8 Global Market for Cardiac Prosthetic Devices (CPD) 3.2 Global Market for Cardiac Rhythm Management (CRM) Devices 3.2.1 Market for CRM Devices in BRICSS Countries 3.2.2 Market for CRM Devices in China 3.2.3 Leading Global CRM Device Vendors 3.2.4 Global Market for Cardiac Monitoring and Diagnostic Devices 3.3 Global Market for Cardiac Pacemakers 3.3.1 North American Market for Cardiac Pacemakers 3.3.2 European Cardiac Pacemaker Market 3.4 Global Market for ICDs 3.4.1 North American Market for ICDs 3.4.2 European Market for ICDs 3.4.3 Asia-Pacific Market for ICDs 4. The U.S. and European Scenario of Cardiac Rhythm Management 4.1 U.S. Opportunities in Cardiovascular Segment 4.1.1 U.S. Cardiovascular Devices Market 4.2 Data from U.S. ICD Registry 4.2.1 Demographics and ICD Indications in the U.S. 4.2.2 Physician Training and ICD Implant Volume in the U.S. 4.2.3 ICD Types and Adverse Events in the U.S. 4.2.4 ICD Implants in the U.S. 4.2.5 Single Chamber, Dual Chamber and Biventricular Implants in the U.S. 4.2.6 Proportion of ICD Utilization for Primary and Secondary Prevention in the U.S. 4.2.7 Proportion of ICD/CRT-D by Type in the U.S. 4.2.8 Characteristics of ICD Patients in the U.S. 4.3 Cardiac Implants in 45 Californian Hospitals 4.3.1 Annual Volume of Pacemaker Procedures in California 4.3.2 Procedure and Average Implant Costs 4.3.3 Best Cardiology Hospitals in California 4.3.4 Pacemaker Procedure Costs in 42 Californian Hospitals 4.3.5 Cost as a Percentage of Total Reimbursement 4.3.6 Pacemaker Cost as a Percentage of Total Reimbursement 4.4 Future of Pacemaker Implantation in the U.S. 4.5 ICD Complication Rates in the U.S. 4.6 Cost of CRT-D Therapy in the U.S. 4.6.1 Cost of ICDs in the U.S. 4.6.2 Cost for Pacemakers in the U.S. 4.6.3 Options for Negotiating the Costs 4.7 Reimbursement Guide for ICD Implants 4.7.1 Coverage for ICD Therapy 4.7.2 Coverage with Non-Medicare Patients 4.7.3 Coding for ICD Therapy 4.7.4 Hospital Inpatients Procedure Codes 4.7.5 Hospital Outpatient Procedure Codes 4.7.6 C-Codes for ICD Implants 4.7.7 ICD-9-CM Diagnosis Codes 4.7.8 Inpatient Hospital Medicare Payment for ICD Therapy 4.8 ICD Implants in South America 4.9 Pacemaker Implant Rate in Europe 4.10 CRT-D Implants in Europe 4.11 ICD Implants in Europe 4.12 ICD and CRT-D Implants in Europe 4.13 All CRT-P Implants in Europe 4.14 Implanted CRM Devices in Europe by Type and Country 4.15 Comparison between U.S. and European Implant Rates 4.16 Comparison of CRT-D and CRT-P Implant Rates between the U.S. and Europe 4.17 Proportions of Pacing Modes Used in Europe 4.18 Geographic Variations in ICD Implantation in Europe 4.19 ICD Utilization in Europe 4.20 Rates of ICD Implants in Select Countries of Europe 4.21 ICD Implantation and Economic Factors in Europe 4.22 Penetration of Dual Chamber ICDs in Europe 4.23 Number of ICD Implanting Centers in Europe 4.24 Healthcare Factors and ICD Implantation in Europe 4.25 Potential ICD Implant Recipients in Europe 4.26 Status of Cardiac Electrophysiology in ESC Member Countries 4.27 U.K. National Survey on CRM Devices 4.27.1 New Pacemaker Implant Rates in U.K. 4.27.2 New ICD Implant Rate in U.K. 4.27.3 New CRT Implant Rates in U.K. 4.27.4 Total (New and Replacements) CRT Implant Rates in U.K. 4.27.5 Physiological Pacing and Age in U.K. 4.27.6 Projected Pacemaker Sales in U.K., 2008-2016 4.27.7 Projected ICD Sales in U.K. 4.27.8 Projected CRT Device Sales in U.K. 4.27.9 Top Ten CRM Device Implanting Hospitals in U.K. 4.28 U.K.: ICD Registry 4.28.1 CRT Activity in U.K. 4.28.2 Over-Performance of ICD and CRT-D Activity Compared to Plan 4.28.3 CRT Activity in U.K. 4.28.4 Pacemaker Activity 4.28.5 Increasing Role of CRT in England 4.28.6 High-Energy Implants for Primary Prevention in U.K. 4.28.7 High-Energy Implants for Secondary Prevention in U.K., 2009 4.28.8 Increasing Role of CRT in U.K. 4.28.9 CRT-P and CRT-D 4.28.10 Survival after CRM Device Implants in U.K. 4.28.11 Pacemaker Implantation Rate in U.K.’s Anglia Network Region 4.28.12 New ICD Implant Rate in Anglia Network 4.28.13 CRT Implant Rate in Anglia Network 4.29 CRM Device Implants in Switzerland 4.30 CRM Device Implants in Italy 4.31 ICD Implants in Spain 4.31.1 Total Number of Implantations in Spain 4.31.2 New Implants vs. Replacements in Spain 4.31.3 Age and Gender of Device Recipients in Spain 4.31.4 Underlying Heart Diseases in Spain Requiring CRM Device 4.31.5 LVEF Patients in Spanish Registry 4.31.6 Clinical Arrhythmias Requiring ICD Implants in Spain 4.31.7 Clinical Presentations of Arrhythmias in Spanish Patient 4.31.8 Cardiovascular Diseases in Serbia 4.31.9 CRM Devices Implants in Serbia, 2009 4.32 ICD Implants by Type in Israel 4.32.1 Initial and Replacement ICD Implants in Israel, 2010 4.32.2 ICD Implants in Israel by Age and Ethnicity 4.32.3 Doubling of ICD Implants in Israel, 2011 4.32.4 Off-Label ICD Implants in Israel 5. Selected Company Profiles 5.1 Biotronik, Inc. 5.1.1 Selected CRM Products from Biotronik 5.1.1.1 Evia DR-T 5.1.1.2 Estella DR-T 5.1.1.3 Effecta DR 5.1.1.4 Cyclos 990 DR-T 5.1.1.5 Philos II DR-T 5.1.1.6 Talos DR 5.1.1.7 Axios-S 5.1.2 Biotronik’s ICDs for Tachyarrhythmia 5.1.2.1 Lumax 540 VR-T DX 5.1.2.2 Lumax 540 VR-T 5.1.3 Biotronik’s CRT Products 5.1.3.1 Lumax 540 HF-T 5.1.3.2 Stratos LV-T 5.1.3.3 Lumax 340 HF-T 5.2 Boston Scientific Corporation 5.2.1 Selected CRM Products from Boston 5.2.1.1 PeriVac Pericardiocentesis Kits 5.2.1.2 COGNIS (CRT-D) 5.2.1.3 Contak Renewal 3 RF 5.2.1.4 Contak Renewal TR 5.2.1.5 Livian CRT-DS 5.2.1.6 Confient ICD 5.2.1.7 Teligen ICD 5.2.1.8 Vitality ICD 5.2.1.9 The Altrua Pacemaker Family 5.3 Cardiac Science Corporation 5.3.1 Powerheart AED G3 Plus 5.3.2 Powerheart AED G3 Pro 5.3.3 Powerheart AED G3 5.3.4 Powerheart AED G3 Trainer 5.4 Esaote S.p.A 5.4.1 P80 5.4.2 P8000 5.5 Fukuda Denshi, Co., Ltd. 5.5.1 CardiMax FCP-7101 5.5.2 CardiMax FX-7102 5.5.3 CardiMax FX-7202 5.5.4 CardiMax FX-7402 5.6 Laerdal Medical AS 5.6.1 Defibrillation Products from Laerdal 5.6.1.1 HeartStart HSI First Aid Defibrillator 5.6.1.2 HeartStart FR2 Automated External Defibrillator 5.6.1.3 HeartStart FRx 5.6.1.4 HeartStart MRx 5.7 Medtronic, Inc. 5.7.1 Medtronic’s CRM Products 5.7.1.1 Reveal DX and Reveal XT Insertable Cardiac Monitors 5.7.1.2 Protecta XT (CRT-D) 5.7.1.3 Protecta (CRT-D) 5.7.1.4 Consulta (CRT-D) 5.7.1.5 Maximo II (CRT-D) 5.7.1.6 Historical CRT Devices 5.7.2 Medtronic’s CRT-P Devices 5.7.2.1 Syncra CRT-P 5.7.3 Medtronic’s ICDs 5.7.3.1 Protecta XT DR and VR 5.7.3.2 Secura DR and VR 5.8 Nihon Kohden Corporation 5.8.1 Cardiofax ECG 9620 5.8.2 Cardiofax C ECG 1150 5.8.3 CardiofaxS ECG -1250 5.8.4 Cardiofax M ECG-1350 5.8.5 Cardiofax V ECG-1500 Series 5.9 Philips Healthcare 5.9.1 Selected CRM Products from Philips 5.9.1.1 HeartStart FR2+ 5.9.1.2 HeartStart FRx Defibrillator 5.9.1.3 HeartStart OnSite (HIS) 5.9.1.4 HeartStart MRx ALS Monitor/Defibrillator 5.9.1.5 HeartStart XL Defibrillator/Monitor 5.9.1.6 Q-CPR Measurement and Feedback Tool 5.9.1.7 HeartStart Telemedicine System 5.9.1.8 HeartStart Event Review Pro—EMS 5.9.1.9 HeartStart Event Review Pro—Hospitals 5.9.1.10 HeartStart Data Messenger 5.9.1.11 HeartStart Event Review for AEDs 5.9.1.12 HeartStart Configure 5.9.1.13 HeartStart Event Review Pro—Hospitals 5.10 Schiller AG 5.10.1 Schiller’s Public Access Defibrillators 5.10.1.1 FRED easy (Automatic) 5.10.1.2 FRED easyport 5.11 Sorin Group USA, Inc. 5.11.1 Selected CRM Products from Sorin 5.11.1.1 Paradym (CRT) 5.11.1.2 Ovatio (CRT) 5.11.1.3 Paradym DR 5.11.1.4 Paradym VR 5.11.1.5 Esprit DR 5.12 St. Jude Medical, Inc. 5.12.1 Accent Pacemakers 5.12.2 Affinity Pacemakers 5.12.3 Entity Pacemakers 5.12.4 Identity ADx Pacemakers 5.12.5 Integrity Pacemakers 5.12.6 Microny Pacemakers 5.12.7 Regency Pacemakers 5.12.8 Temporary Pacemakers 5.12.9 Verity ADx Pacemakers 5.12.10 Victory Pacemakers 5.12.11 Zephyr Pacemakers 5.12.12 Anthem CRT-P 5.12.13 Atlas II HF CRT-D 5.12.14 Epic HF CRT-D 5.12.15 Epic II HF CRT-D 5.12.16 Frontier II CRT-P 5.12.17 Promote Accel CRT-D 5.12.18 Promote Plus CRT-D 5.12.19 Unify CRT-D 5.12.20 Atlas ICD Family 5.12.21 Atlas II ICD Family 5.12.22 Current Accel ICD 5.12.23 Current Plus ICD 5.12.24 Epic ICD 5.12.25 Epic II ICD Family 5.13 Welch Allyn, Inc. 5.13.1 AED10 Defibrillator 5.14 Zoll Medical Corporation 5.14.1 Selected Zoll’s CRM Products 5.14.1.1 AED Plus Automated External Defibrillator 5.14.1.2 AED Plus Automated External Defibrillator 5.14.1.3 Auto-Pulse Non-Invasive Cardiac Support Pump 5.14.1.4 CodeNet Resusciation Data Management System 5.14.1.5 Defibrillator Dashboard Software 5.14.1.6 E Series Defibrillators 5.14.1.7 Zoll Life Vest 5.14.1.8 M Series CCT 5.14.1.9 M Series Defibrillators 5.14.1.10 Propaq MD 5.14.1.11 R Series Monitor Defibrillator Appendix 1: The Evolution of Pacemakers: An Electronics Perspective 236 Appendix 1.1: Excitation and Conducting System in Heart 236 Appendix 1.2: Cardiac Signals 237 Appendix 1.2.1: Surface Electrocardiogram 237 Appendix 1.2.2: Intracardiac Electrogram (IECG) 238 Appendix 1.2.3: Arrhythmia 238 Appendix 1.3: History and Development of Cardiac Pacing 239 Appendix 1.3.1: Hyman’s Pacemaker 240 Appendix 1.3.2: Dawn of Modern Era: Implantable Pacemakers 241 Appendix 1.3.3: Demand Pacemaker 242 Appendix 1.3.4: Dual-Chamber Pacemaker 244 Appendix 1.3.5: Rate-Responsive Pacemaker 245 Appendix 1.3.6: New Features in Modern Pacemakers 245 Appendix 2: Glossary of Terms: Cardiac Rhythm Disorders 247 INDEX OF FIGURES Figure 2.1: Incidence of SCD in the U.S. by Age and Gender 25 Figure 2.2: Radiograph of a Nuclear Pacemaker 27 Figure 2.3: Photograph of an Older Pacemaker Showing the Discrete Components 27 Figure 2.4: Radiograph of a Current Model of Pacemaker of Microprocessor-based Design 28 Figure 2.5: Print-out of a Pacemaker Telemetry Data 29 Figure 2.6: Intracardiac Electrogram from a Pacemaker 29 Figure 2.7: Connector Block Types in Pacemakers 30 Figure 2.8: Diagram of a Typical Bipolar Pacing Lead 30 Figure 2.9: The Five Basic Types of Leads in Pacemakers 31 Figure 2.10: Diagram of a Steroid-eluting Lead Design in Pacemaker 31 Figure 2.11: Conductor Coil Types in Pacemakers 32 Figure 2.12: Fixation Types in Pacemakers 33 Figure 2.13: Connector Types in Pacemakers 33 Figure 2.14: Unipolar and Bipolar Pacing Systems 34 Figure 2.15: Strength Duration Curve 35 Figure 2.16: Comparison of Surface Cardiogram Recordings 36 Figure 2.17: Raw and Filtered Electrograms as Transmetered from a Pacemaker 37 Figure 2.18: Comparison of a Signal with a Good Slew Rate and Poor Slew Rate 37 Figure 2.19: Capture Threshold vs. Time Plot in Pacing 38 Figure 2.20: Pacing Strip Showing Magnetic Response 40 Figure 2.21: Automatic Interval in Single Chamber Pacing 40 Figure 2.22: Escape Interval in Single Chamber Pacing 41 Figure 2.23: Refractory Period in Single Chamber Pacing 41 Figure 2.24: VVI Mode in Single Chamber Pacing 42 Figure 2.25: VVT Mode in Single Chamber Pacing 42 Figure 2.26: VOO Mode in Single Chamber Pacing 42 Figure 2.27: AAT Mode in Single Chamber Pacing 43 Figure 2.28: AAI Mode in Single Chamber Pacing 43 Figure 2.29: AAT Mode in Single Chamber Pacing 43 Figure 2.30: Hysteresis in Single Chamber Pacing 44 Figure 2.31: Fusion in Single Chamber Pacing 45 Figure 2.32: Pseudofusion in Single Chamber Pacing 45 Figure 2.33: Latency in Single Chamber Pacing 46 Figure 2.34: AV Interval in Dual Chamber Pacing 46 Figure 2.35: Differential AV Interval in Dual Chamber Pacing 47 Figure 2.36: Adaptive AVI in Dual Chamber Pacing 47 Figure 2.37: Atrial Escape Interval in Dual Chamber Pacing 48 Figure 2.38: PVARP in Dual Chamber Pacing 48 Figure 2.39: URL in Dual Chamber Pacing 49 Figure 2.40: Relationship between the Major Timing Cycles in Dual Chamber Pacing 50 Figure 2.41: Ventricular-based Timing at Low and High Rates 50 Figure 2.42: Totally Inhibited Pacing in Dual Chamber Pacemaker 51 Figure 2.43: AR Pacing in Dual Chamber Pacing 52 Figure 2.44: Atrial Inhibited Ventricular Pace (PV) 52 Figure 2.45: AV Pacing in Dual Chamber Pacemaker 52 Figure 2.46: DVI-C (Committed) Mode in Dual Chamber Pacing 53 Figure 2.47: DVI-NC (Non-Committed) Mode in Dual Chamber Pacing 53 Figure 2.48: Sensing of Both Atrium and Ventricle by DDI Mode 53 Figure 2.49: Comparison of DDD, DDI and DVI in Dual Chamber Pacing 54 Figure 2.50: VDD Mode in Dual Chamber Pacing 54 Figure 2.51: Block (Multiblock) in Dual Chamber Pacing 55 Figure 2.52: Pseudo-Wenckebach Behavior in Dual Mode Pacing 56 Figure 2.53: Rate Smoothing in Dual Chamber Pacing 56 Figure 2.54: Sensor Output in Relation to Activity 58 Figure 2.55: Diagram Showing Signals from a Piezoelectric Sensor 59 Figure 2.56: The Slope Values and Determination of Target Heart Rate 59 Figure 2.57: Reaction/Acceleration Time and Recovery/Deceleration Time 60 Figure 2.58: True Bipolar and Integrated Bipolar Sensing in ICDs 66 Figure 2.59: Detection of Arrhythmia Using Rate Stability Criterion 67 Figure 2.60: Sudden Onset Criteria to Differentiate VT from Sinus Tachycardia 68 Figure 2.61: Truncated Exponential Monophasic Waveform 68 Figure 2.62: DFT Probability Curve 69 Figure 2.63: Success of ATP 70 Figure 3.1: Global Cardiac Devices Market, 2010-2017 84 Figure 3.2: North American Market for Cardiac Medical Devices, 2010-2017 85 Figure 3.3: European Market for Cardiac Medical Devices, 2010-2017 86 Figure 3.4: Asia-Pacific Market for Cardiac Devices, 2010-2017 87 Figure 3.5: Global Market for Interventional Cardiac Devices, 2010-2017 88 Figure 3.6: Global Market for Peripheral Vascular Devices, 2010-2017 89 Figure 3.7: Global Peripheral Vascular Device Market Share by Company, 2010 89 Figure 3.8: Global Market for Electrophysiology Devices (EP), 2010-2017 90 Figure 3.9: Global Market for Cardiac Prosthetic Devices, 2010-2017 91 Figure 3.10: Global Market for Cardiac Rhythm Management (CRM) Devices, 2010-2017 92 Figure 3.11: CRM Devices Market in BRICSS Countries, 2010-2017 92 Figure 3.12: Chinese Market for CRM Devices, 2010-2017 93 Figure 3.13: Global Share of CRM Products by Vendor 94 Figure 3.14: Global Market for Cardiac Monitoring and Diagnostic Devices (CM&D), 2010-2017 95 Figure 3.15: Global Market for Cardiac Pacemakers, 2010-2017 95 Figure 3.16: North American Pacemaker Market, 2010-2017 96 Figure 3.17: European Pacemaker Market, 2010-2017 97 Figure 3.18: Global Market for ICDs, 2010-2017 98 Figure 3.19: North American Market for ICDs, 2010-2017 98 Figure 3.20: European Market for ICDs, 2010-2017 99 Figure 3.21: Asia-Pacific Market for ICDs, 2010-2017 100 Figure 4.1: Percentage of Deaths from Cardiovascular Diseases in the U.S. 101 Figure 4.2: ICD Implants in the U.S., 2006-2009 107 Figure 4.3: Implanted ICD Types in the U.S., 2006-2009 108 Figure 4.4: First ICD/CRT-D Implantation by Indication in the U.S. 109 Figure 4.5: Distribution of ICD Implants by Type in the U.S. 110 Figure 4.6: Annual Volume of Pacemaker Procedures in 42 Hospitals in California 111 Figure 4.7: Average Implant Cost in 34 Californian Hospitals 112 Figure 4.8: Total Pacemaker Procedure Costs in 42 Californian Hospitals 113 Figure 4.9: Defibrillator Cost as a Percentage of Total Reimbursement for Medicare FFS Patients 114 Figure 4.10: Pacemaker Cost as a Percentage of Total Reimbursement for Commercial HMO and PPO Patients 115 Figure 4.11: Future Demand for Pacemaker Implants in the U.S. by Type of Device, 2010-2028 116 Figure 4.12: Comparison of ICD Implants between Latin America, the U.S. and Europe 127 Figure 4.13: All Pacemaker Implants in Europe, 2009 128 Figure 4.14: All CRT-D Implants in Europe, 2009 129 Figure 4.15: All ICD Implants in Europe, 2009 130 Figure 4.16: All ICD and CRT-D Implants in Europe, 2009 131 Figure 4.17: All CRT-P Implants in Europe, 2009 132 Figure 4.18: Comparison between U.S. and European Implant Rates 135 Figure 4.19: Comparison between CRT-D and CRT-P Implant Rates in the U.S. and Europe 136 Figure 4.20: Pacing Modes Used in Europe by Percentage 137 Figure 4.21: Number of ICDs Per Million Inhabitants in Select Countries of Europe, 2006-2008 139 Figure 4.22: Percentage of Single vs. Dual Chambered ICDs in Europe, 2008 140 Figure 4.23: New Implant Rates in U.K., 1999-2009 153 Figure 4.24: New ICD Implant Rates in U.K., 1999-2009 154 Figure 4.25: New CRT Implant Rates in U.K., 1999-2009 154 Figure 4.26: Total CRT Implant Rate in U.K., 1999-2009 155 Figure 4.27: Pacing as Percentage of Total New Implants in England and Wales, 2009 156 Figure 4.28: Projected Pacemaker Sales in U.K., 2008-2016 157 Figure 4.29: Projected ICD Sales in U.K., 2008-2016 157 Figure 4.30: Projected CRT Implant Sales in U.K., 2008-2016 158 Figure 4.31: Top Ten CRM Device Implanting Hospitals in U.K, 2007 and 2008 159 Figure 4.32: ICD and CRT Activity in NW London for April to July 2010 160 Figure 4.33: New, Planned and Projected Activity for CRTP in 2010-2011 161 Figure 4.34: Actual New and Changed Device in 2010 and Projected Pacemaker Activity in 2011 162 Figure 4.35: Increasing Role of CRT in England, 2000-2009 163 Figure 4.36: High-Energy Implants for Primary Prevention in U.K., 2009 163 Figure 4.37: High-Energy Implants for Secondary Prevention in U.K., 2009 164 Figure 4.38: Increasing Role of CRT Devices (New) in U.K., 2009 165 Figure 4.39: CRT Type and Symptom Indication Percentage in U.K., 2009 165 Figure 4.40: Pacemaker New Implant Rate in Anglia Network, 2003-2009 166 Figure 4.41: ICD New Implant Rate in Anglia Network, 2003-2009 167 Figure 4.42: CRT Implant Rate in Anglia Network, 2003-2009 168 Figure 4.43: Pacemaker and ICD Implants in Switzerland, 1998-2008 169 Figure 4.44: ICD Implantations Reported to the Registry and Estimated by EUCOMED, 2003-2009 171 Figure 4.45: ICD Implantation per Million People Reported to the Registry and Estimated by EUCOMED, 2003-2009 172 Figure 4.46: Types of Heart Devices Reported for Total Implantations in Spain 173 Figure 4.47: Left Ventricular Ejection Fraction (LVEF) of Patients in the Spanish Registry 173 Figure 4.48: Clinical Arrhythmias Requiring ICD Implants in Spain 174 Figure 4.49: Clinical Presentations of Arrhythmias in Spanish Patients 175 Figure 4.50: CRM Device Implants by Type in Serbia, 2008 and 2009 176 Figure 4.51: Total Number of CRM Device Implants in Serbia, 2000-2009 177 Figure 4.52: New ICD Implants by Type in Israel 177 Figure 4.53: Number of ICD Implants in Israel from July 2010 to February 2011 178 Figure 4.54: ICD Implantations in Israel by Age and Ethnicity 179 Figure 4.55: New ICD Implants in Israel, 2010-2011 180 Figure 4.56: Number of New ICD Implants in Israel by Month, 2010-2011 181 Figure 4.57: ICD Implantation by Age and Gender in Israel, 2010-2011 181 Figure 4.58: ICD Implantation Percentage by Gender in Israel vs. the U.S. 182 Figure 4.59: New ICD and CRT-D Implantation by Indication in Israel 183 Figure 4.60: Distribution of Implantations by Type of Devices in Israel 183 Figure 4.61: Off-Label ICD Implants in Israel 184 Figure A1.1: The Cardiac Conducting System 237 Figure A1.2: A Typical Electrocardiogram (ECD) 238 Figure A1.3: Basic Pacemaker Functional Block Diagram 239 Figure A1.4: The First Artificial Pacemaker 240 Figure A1.5: Block Diagram of Hyman’s Pacemaker 240 Figure A1.6: Schematic of First Implanted Pacemaker 241 Figure A1.7: Block Diagram of Demand Pacemaker 242 Figure A1.8: Schematic of the Pulse Generator of the First Demand Pacemaker 242 Figure A1.9: Schematic of Dual-Chamber Demand Pacemaker 244 Figure A1.10: Block Diagram of a Rate-Responsive Pacemaker 245 Figure A1.11: Block Diagram of a Typical Modern Pulse Generator 246 INDEX OF TABLES Table 2.1: NASPE/BPEG (NBG) Codes 26 Table 2.2: Medication Effects of Sensing in a Pacemaker 36 Table 2.3: Programmable Features of a Single Chamber Pacemaker 39 Table 2.4: Comparison of Two Models of Cardiac Pacemakers from Biotronik 61 Table 2.5: Comparison of Two Models of Pacemakers from Boston Scientific 62 Table 2.6: Comparison of Two Models of Pacemakers from Medtronic 63 Table 2.7: NBD Codes for ICDs 64 Table 2.8: Product Comparison Chart for External Defibrillators from Burdick 76 Table 2.9: Product Comparison Chart for External Defibrillators from Cardiac Science 77 Table 2.10: Product Comparison Chart for External Defibrillators from Medtronic 79 Table 4.1: Cardiovascular Medical Procedures in the U.S., 2009 102 Table 4.2: Estimated Direct Cost of Cardiovascular Disease and Stroke in the U.S., 2009 102 Table 4.3: U.S. Cardiovascular Devices Market, 2008-2012 103 Table 4.4: National ICD Registry (2006-2009): Medical History and Baseline Tests 105 Table 4.5: Demographics and ICD Indications in the U.S. 105 Table 4.6: Physician Training and ICD Implant Volume in the U.S. 106 Table 4.7: ICD Types and Adverse Events in the U.S., 2006-2009 107 Table 4.8: Characteristics of Patients with ICD Implants in the U.S. and Canadian Registries 110 Table 4.9: Comprehensive Calculator for CRT-D 119 Table 4.10: Comprehensive Calculator for Single Channel ICD 120 Table 4.11: Comprehensive Calculator for Pacemaker 120 Table 4.12: Physician Procedure Codes 122 Table 4.13: ICD-9-CM Procedure Codes 123 Table 4.14: ICD-9-CM Code for an Electrophysiology Study and Non-Invasive Programmed Stimulation 123 Table 4.15: Hospital Outpatient Procedure Codes 123 Table 4.16: C-Codes for ICD Implants 124 Table 4.17: ICD-9-CM Diagnosis Codes 125 Table 4.18: Heart Failure Diagnosis Codes and Medicare’s Classification 125 Table 4.19: Codes for Myocardial Infarction 126 Table 4.20: Inpatient Hospital Medicare Payment for ICD Therapy 127 Table 4.21: ICD Implants in Latin America by Country, 2006 and 2007 128 Table 4.22: Implanted CRM Devices in Europe by Type and Country 133 Table 4.23: Demographic, Economic and Insurance Data for Europe 137 Table 4.24: Number of ICD Implanting Centers in Europe 141 Table 4.25: Status of Cardiac Electrophysiology in ESC Member Countries, 2008 and 2009 143 Table 2.26: Current Activity Rate Compared to National Target and National Average 160 Table 4.27: Survival after High-Energy Implants in U.K., 2009 166 Table 4.28: Pacemaker and ICD Implant Rate in Anglia Network, 2006-2009 167 Table 4.29: New CRT and Total CRT Implant Rate in Anglia Network, 2006-2009 168 Table 4.30: Number of CRM Device Implantations in Switzerland and Neighboring Countries, 2007 170 Table 5.1: Medtronic’s Ablation Products for Arrhythmia 201 Table 5.2: Medtronic’s Cardiac CryoAblation System 202 Table 5.3: Medtronic’s Surgical Ablation Products 203 Table 5.4: Medtronic’s Pacemakers 207

Companies Mentioned

- Biotronik, Inc. - Boston Scientific Corporation - Cardiac Science Corporation - Esaote S.p.A - Fukuda Denshi, Co., Ltd. - Laerdal Medical AS - Medtronic, Inc. - Nihon Kohden Corporation - Philips Healthcare - Schiller AG - Sorin Group USA, Inc. - St. Jude Medical, Inc. - Welch Allyn, Inc. - Zoll Medical Corporation