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Cardiac Rhythm Management Devices World Markets

TriMark Publications
October 1, 2011
250 Pages - SKU: TRI6655638

Abstract Table of Contents Related Reports

Countries covered: Global

Cardiac Rhythm Management Devices World Markets

In the last five decades, electronic cardiac medicine has witnessed dramatic technological developments. The cardiac rhythm management products mainly marketed by a handful of global players are used to treat arrhythmias, specifically supraventricular arrhythmias (SVA) and ventricular arrhythmias (VA). The different types of SVA are premature atrial contractions (PAC), supraventricular tachycardia (SVT), sick sinus syndrome (SSS), atrial fibrillation (A-fib) and atrial flutter (AFL). Varying forms of VA are premature ventricular complex (PVC), ventricular tachycardia (VT) and ventricular fibrillation (VF). These cardiac disorders are treated with the aid of different types of electronic cardiac devices. This TriMark Publications report focuses on the global and regional markets for all cardiac rhythm management (CRM) devices, and includes data on implant volumes, procedure costs and reimbursement coverage. This study also covers in detail important areas within CRM such as: implantable cardioverter-defibrillators (ICDs), cardiovascular implantable electronic devices (CIEDs), resynchronisation therapy (CRT), implantable loop recorders (ILRs) and implantable hemodynamic monitoring (IHM).

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; 2.2 Abnormal Rhythms; 2.3 Causes of Heart Rhythm Disorders; 2.4 Sudden Cardiac Death (SCD); 2.5 Cardiac Rhythm Management Devices: An Overview; 2.6 Basic Concepts and Terms in Pacemaker Procedures; 2.7 Basic Single Chamber Pacing; 2.8 Additional Concepts in Single Chamber Pacing; 2.9 Concepts and Modes in Dual Chamber Pacing; 2.10 Tips for Buying Cardiac Pacemakers; 2.11 Implantable Cardioverter-Defibrillators (ICDs); 2.12 Recommended Replacement Time for ICDs; 2.13 Cardiac Resynchronization Therapy (CRT); 2.15 External Cardioverter-Defibrillators; 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; 3.2 Global Market for Cardiac Rhythm Management (CRM) Devices; 3.3 Global Market for Cardiac Pacemakers; 3.4 Global Market for ICDs
4. The U.S. and European Scenario of Cardiac Rhythm Management: 4.1 U.S. Opportunities in Cardiovascular Segment; 4.2 Data from U.S. ICD Registry; 4.3 Cardiac Implants in 45 Californian Hospitals; 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.; 4.7 Reimbursement Guide for ICD Implants; 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; 4.28 U.K.: ICD Registry; 4.29 CRM Device Implants in Switzerland; 4.30 CRM Device Implants in Italy; 4.31 ICD Implants in Spain; 4.32 ICD Implants by Type in Israel
5. Selected Company Profiles: 5.1 Biotronik, Inc.; 5.2 Boston Scientific Corporation; 5.3 Cardiac Science Corporation; 5.4 Esaote S.p.A; 5.5 Fukuda Denshi, Co., Ltd.; 5.6 Laerdal Medical AS; 5.7 Medtronic, Inc.; 5.8 Nihon Kohden Corporation; 5.9 Philips Healthcare; 5.10 Schiller AG; 5.11 Sorin Group USA, Inc.; 5.12 St. Jude Medical, Inc.; 5.13 Welch Allyn, Inc.; 5.14 Zoll Medical Corporation
Appendix 1: The Evolution of Pacemakers: An Electronics Perspective
Appendix 1.1: Excitation and Conducting System in Heart
Appendix 1.2: Cardiac Signals
Appendix 1.2.1: Surface Electrocardiogram
Appendix 1.2.2: Intracardiac Electrogram (IECG)
Appendix 1.2.3: Arrhythmia
Appendix 1.3: History and Development of Cardiac Pacing
Appendix 1.3.1: Hyman’s Pacemaker
Appendix 1.3.2: Dawn of Modern Era: Implantable Pacemakers
Appendix 1.3.3: Demand Pacemaker
Appendix 1.3.4: Dual-Chamber Pacemaker
Appendix 1.3.5: Rate-Responsive Pacemaker
Appendix 1.3.6: New Features in Modern Pacemakers
Appendix 2: Glossary of Terms: Cardiac Rhythm Disorders
INDEX OF FIGURES: Figure 2.1: Incidence of SCD in the U.S. by Age and Gender; Figure 2.2: Radiograph of a Nuclear Pacemaker; Figure 2.3: Photograph of an Older Pacemaker Showing the Discrete Components; Figure 2.4: Radiograph of a Current Model of Pacemaker of Microprocessor-based; Design; Figure 2.5: Print-out of a Pacemaker Telemetry Data; Figure 2.6: Intracardiac Electrogram from a Pacemaker; Figure 2.7: Connector Block Types in Pacemakers; Figure 2.8: Diagram of a Typical Bipolar Pacing Lead; Figure 2.9: The Five Basic Types of Leads in Pacemakers; Figure 2.10: Diagram of a Steroid-eluting Lead Design in Pacemaker; Figure 2.11: Conductor Coil Types in Pacemakers; Figure 2.12: Fixation Types in Pacemakers; Figure 2.13: Connector Types in Pacemakers; Figure 2.14: Unipolar and Bipolar Pacing Systems; Figure 2.15: Strength Duration Curve; Figure 2.16: Comparison of Surface Cardiogram Recordings; Figure 2.17: Raw and Filtered Electrograms as Transmetered from a Pacemaker; Figure 2.18: Comparison of a Signal with a Good Slew Rate and Poor Slew Rate; Figure 2.19: Capture Threshold vs. Time Plot in Pacing; Figure 2.20: Pacing Strip Showing Magnetic Response; Figure 2.21: Automatic Interval in Single Chamber Pacing; Figure 2.22: Escape Interval in Single Chamber Pacing; Figure 2.23: Refractory Period in Single Chamber Pacing; Figure 2.24: VVI Mode in Single Chamber Pacing; Figure 2.25: VVT Mode in Single Chamber Pacing; Figure 2.26: VOO Mode in Single Chamber Pacing; Figure 2.27: AAT Mode in Single Chamber Pacing; Figure 2.28: AAI Mode in Single Chamber Pacing; Figure 2.29: AAT Mode in Single Chamber Pacing; Figure 2.30: Hysteresis in Single Chamber Pacing; Figure 2.31: Fusion in Single Chamber Pacing; Figure 2.32: Pseudofusion in Single Chamber Pacing; Figure 2.33: Latency in Single Chamber Pacing; Figure 2.34: AV Interval in Dual Chamber Pacing; Figure 2.35: Differential AV Interval in Dual Chamber Pacing; Figure 2.36: Adaptive AVI in Dual Chamber Pacing; Figure 2.37: Atrial Escape Interval in Dual Chamber Pacing; Figure 2.38: PVARP in Dual Chamber Pacing; Figure 2.39: URL in Dual Chamber Pacing; Figure 2.40: Relationship between the Major Timing Cycles in Dual Chamber Pacing; Figure 2.41: Ventricular-based Timing at Low and High Rates; Figure 2.42: Totally Inhibited Pacing in Dual Chamber Pacemaker; Figure 2.43: AR Pacing in Dual Chamber Pacing; Figure 2.44: Atrial Inhibited Ventricular Pace (PV); Figure 2.45: AV Pacing in Dual Chamber Pacemaker; Figure 2.46: DVI-C (Committed) Mode in Dual Chamber Pacing; Figure 2.47: DVI-NC (Non-Committed) Mode in Dual Chamber Pacing; Figure 2.48: Sensing of Both Atrium and Ventricle by DDI Mode; Figure 2.49: Comparison of DDD, DDI and DVI in Dual Chamber Pacing; Figure 2.50: VDD Mode in Dual Chamber Pacing; Figure 2.51: Block (Multiblock) in Dual Chamber Pacing; Figure 2.52: Pseudo-Wenckebach Behavior in Dual Mode Pacing; Figure 2.53: Rate Smoothing in Dual Chamber Pacing; Figure 2.54: Sensor Output in Relation to Activity; Figure 2.55: Diagram Showing Signals from a Piezoelectric Sensor; Figure 2.56: The Slope Values and Determination of Target Heart Rate; Figure 2.57: Reaction/Acceleration Time and Recovery/Deceleration Time; Figure 2.58: True Bipolar and Integrated Bipolar Sensing in ICDs; Figure 2.59: Detection of Arrhythmia Using Rate Stability Criterion; Figure 2.60: Sudden Onset Criteria to Differentiate VT from Sinus Tachycardia; Figure 2.61: Truncated Exponential Monophasic Waveform; Figure 2.62: DFT Probability Curve; Figure 2.63: Success of ATP; Figure 3.1: Global Cardiac Devices Market, 2010-2017; Figure 3.2: North American Market for Cardiac Medical Devices, 2010-2017; Figure 3.3: European Market for Cardiac Medical Devices, 2010-2017; Figure 3.4: Asia-Pacific Market for Cardiac Devices, 2010-2017; Figure 3.5: Global Market for Interventional Cardiac Devices, 2010-2017; Figure 3.6: Global Market for Peripheral Vascular Devices, 2010-2017; Figure 3.7: Global Peripheral Vascular Device Market Share by Company, 2010; Figure 3.8: Global Market for Electrophysiology Devices (EP), 2010-2017; Figure 3.9: Global Market for Cardiac Prosthetic Devices, 2010-2017; Figure 3.10: Global Market for Cardiac Rhythm Management (CRM) Devices,; 2010-2017; Figure 3.11: CRM Devices Market in BRICSS Countries, 2010-2017; Figure 3.12: Chinese Market for CRM Devices, 2010-2017; Figure 3.13: Global Share of CRM Products by Vendor; Figure 3.14: Global Market for Cardiac Monitoring and Diagnostic Devices (CM&D),; 2010-2017; Figure 3.15: Global Market for Cardiac Pacemakers, 2010-2017; Figure 3.16: North American Pacemaker Market, 2010-2017; Figure 3.17: European Pacemaker Market, 2010-2017; Figure 3.18: Global Market for ICDs, 2010-2017; Figure 3.19: North American Market for ICDs, 2010-2017; Figure 3.20: European Market for ICDs, 2010-2017; Figure 3.21: Asia-Pacific Market for ICDs, 2010-2017; Figure 4.1: Percentage of Deaths from Cardiovascular Diseases in the U.S.; Figure 4.2: ICD Implants in the U.S., 2006-2009; Figure 4.3: Implanted ICD Types in the U.S., 2006-2009; Figure 4.4: First ICD/CRT-D Implantation by Indication in the U.S.; Figure 4.5: Distribution of ICD Implants by Type in the U.S.; Figure 4.6: Annual Volume of Pacemaker Procedures in 42 Hospitals in California; Figure 4.7: Average Implant Cost in 34 Californian Hospitals; Figure 4.8: Total Pacemaker Procedure Costs in 42 Californian Hospitals; Figure 4.9: Defibrillator Cost as a Percentage of Total Reimbursement for; Medicare FFS Patients; Figure 4.10: Pacemaker Cost as a Percentage of Total Reimbursement for; Commercial HMO and PPO Patients; Figure 4.11: Future Demand for Pacemaker Implants in the U.S. by Type of Device,; 2010-2028; Figure 4.12: Comparison of ICD Implants between Latin America, the U.S. and; Europe; Figure 4.13: All Pacemaker Implants in Europe, 2009; Figure 4.14: All CRT-D Implants in Europe, 2009; Figure 4.15: All ICD Implants in Europe, 2009; Figure 4.16: All ICD and CRT-D Implants in Europe, 2009; Figure 4.17: All CRT-P Implants in Europe, 2009; Figure 4.18: Comparison between U.S. and European Implant Rates; Figure 4.19: Comparison between CRT-D and CRT-P Implant Rates in the U.S. and; Europe; Figure 4.20: Pacing Modes Used in Europe by Percentage; Figure 4.21: Number of ICDs Per Million Inhabitants in Select Countries of; Europe, 2006-2008; Figure 4.22: Percentage of Single vs. Dual Chambered ICDs in Europe, 2008; Figure 4.23: New Implant Rates in U.K., 1999-2009; Figure 4.24: New ICD Implant Rates in U.K., 1999-2009; Figure 4.25: New CRT Implant Rates in U.K., 1999-2009; Figure 4.26: Total CRT Implant Rate in U.K., 1999-2009; Figure 4.27: Pacing as Percentage of Total New Implants in England and Wales,; 2009; Figure 4.28: Projected Pacemaker Sales in U.K., 2008-2016; Figure 4.29: Projected ICD Sales in U.K., 2008-2016; Figure 4.30: Projected CRT Implant Sales in U.K., 2008-2016; Figure 4.31: Top Ten CRM Device Implanting Hospitals in U.K, 2007 and 2008; Figure 4.32: ICD and CRT Activity in NW London for April to July 2010; Figure 4.33: New, Planned and Projected Activity for CRTP in 2010-2011; Figure 4.34: Actual New and Changed Device in 2010 and Projected Pacemaker; Activity in 2011; Figure 4.35: Increasing Role of CRT in England, 2000-2009; Figure 4.36: High-Energy Implants for Primary Prevention in U.K., 2009; Figure 4.37: High-Energy Implants for Secondary Prevention in U.K., 2009; Figure 4.38: Increasing Role of CRT Devices (New) in U.K., 2009; Figure 4.39: CRT Type and Symptom Indication Percentage in U.K., 2009; Figure 4.40: Pacemaker New Implant Rate in Anglia Network, 2003-2009; Figure 4.41: ICD New Implant Rate in Anglia Network, 2003-2009; Figure 4.42: CRT Implant Rate in Anglia Network, 2003-2009; Figure 4.43: Pacemaker and ICD Implants in Switzerland, 1998-2008; Figure 4.44: ICD Implantations Reported to the Registry and Estimated by; EUCOMED, 2003-2009; Figure 4.45: ICD Implantation per Million People Reported to the Registry and; Estimated by EUCOMED, 2003-2009; Figure 4.46: Types of Heart Devices Reported for Total Implantations in Spain; Figure 4.47: Left Ventricular Ejection Fraction (LVEF) of Patients in the; Spanish Registry; Figure 4.48: Clinical Arrhythmias Requiring ICD Implants in Spain; Figure 4.49: Clinical Presentations of Arrhythmias in Spanish Patients; Figure 4.50: CRM Device Implants by Type in Serbia, 2008 and 2009; Figure 4.51: Total Number of CRM Device Implants in Serbia, 2000-2009; Figure 4.52: New ICD Implants by Type in Israel; Figure 4.53: Number of ICD Implants in Israel from July 2010 to February 2011; Figure 4.54: ICD Implantations in Israel by Age and Ethnicity; Figure 4.55: New ICD Implants in Israel, 2010-2011; Figure 4.56: Number of New ICD Implants in Israel by Month, 2010-2011; Figure 4.57: ICD Implantation by Age and Gender in Israel, 2010-2011; Figure 4.58: ICD Implantation Percentage by Gender in Israel vs. the U.S.; Figure 4.59: New ICD and CRT-D Implantation by Indication in Israel; Figure 4.60: Distribution of Implantations by Type of Devices in Israel; Figure 4.61: Off-Label ICD Implants in Israel; Figure A1.1: The Cardiac Conducting System; Figure A1.2: A Typical Electrocardiogram (ECD); Figure A1.3: Basic Pacemaker Functional Block Diagram; Figure A1.4: The First Artificial Pacemaker; Figure A1.5: Block Diagram of Hyman’s Pacemaker; Figure A1.6: Schematic of First Implanted Pacemaker; Figure A1.7: Block Diagram of Demand Pacemaker; Figure A1.8: Schematic of the Pulse Generator of the First Demand Pacemaker; Figure A1.9: Schematic of Dual-Chamber Demand Pacemaker; Figure A1.10: Block Diagram of a Rate-Responsive Pacemaker; Figure A1.11: Block Diagram of a Typical Modern Pulse Generator
INDEX OF TABLES: Table 2.1: NASPE/BPEG (NBG) Codes; Table 2.2: Medication Effects of Sensing in a Pacemaker; Table 2.3: Programmable Features of a Single Chamber Pacemaker; Table 2.4: Comparison of Two Models of Cardiac Pacemakers from Biotronik; Table 2.5: Comparison of Two Models of Pacemakers from Boston Scientific; Table 2.6: Comparison of Two Models of Pacemakers from Medtronic; Table 2.7: NBD Codes for ICDs; Table 2.8: Product Comparison Chart for External Defibrillators from Burdick; Table 2.9: Product Comparison Chart for External Defibrillators from Cardiac; Science; Table 2.10: Product Comparison Chart for External Defibrillators from Medtronic; Table 4.1: Cardiovascular Medical Procedures in the U.S., 2009; Table 4.2: Estimated Direct Cost of Cardiovascular Disease and Stroke in the; U.S., 2009; Table 4.3: U.S. Cardiovascular Devices Market, 2008-2012; Table 4.4: National ICD Registry (2006-2009): Medical History and Baseline Tests; Table 4.5: Demographics and ICD Indications in the U.S.; Table 4.6: Physician Training and ICD Implant Volume in the U.S.; Table 4.7: ICD Types and Adverse Events in the U.S., 2006-2009; Table 4.8: Characteristics of Patients with ICD Implants in the U.S. and; Canadian Registries; Table 4.9: Comprehensive Calculator for CRT-D; Table 4.10: Comprehensive Calculator for Single Channel ICD; Table 4.11: Comprehensive Calculator for Pacemaker; Table 4.12: Physician Procedure Codes; Table 4.13: ICD-9-CM Procedure Codes; Table 4.14: ICD-9-CM Code for an Electrophysiology Study and Non-Invasive; Programmed Stimulation; Table 4.15: Hospital Outpatient Procedure Codes; Table 4.16: C-Codes for ICD Implants; Table 4.17: ICD-9-CM Diagnosis Codes; Table 4.18: Heart Failure Diagnosis Codes and Medicare’s Classification; Table 4.19: Codes for Myocardial Infarction; Table 4.20: Inpatient Hospital Medicare Payment for ICD Therapy; Table 4.21: ICD Implants in Latin America by Country, 2006 and 2007; Table 4.22: Implanted CRM Devices in Europe by Type and Country; Table 4.23: Demographic, Economic and Insurance Data for Europe; Table 4.24: Number of ICD Implanting Centers in Europe; Table 4.25: Status of Cardiac Electrophysiology in ESC Member Countries, 2008; and 2009; Table 2.26: Current Activity Rate Compared to National Target and National; Average; Table 4.27: Survival after High-Energy Implants in U.K., 2009; Table 4.28: Pacemaker and ICD Implant Rate in Anglia Network, 2006-2009; Table 4.29: New CRT and Total CRT Implant Rate in Anglia Network, 2006-2009; Table 4.30: Number of CRM Device Implantations in Switzerland and Neighboring; Countries, 2007; Table 5.1: Medtronic’s Ablation Products for Arrhythmia; Table 5.2: Medtronic’s Cardiac CryoAblation System; Table 5.3: Medtronic’s Surgical Ablation Products; Table 5.4: Medtronic’s Pacemakers

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