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Cardiac Rhythm Management Devices World Markets

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Published Date Oct 1, 2011
Pages 250
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Publisher TriMark Publications LLC

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This TriMark Publications 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...
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This TriMark Publications 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
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 Defibrillators

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

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

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 Defibrillators
5.14.1.9 M Series Defibrillators
5.14.1.10 Propaq MD
5.14.1.11 R Series Monitor Defibrillator
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