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市場調査レポート - 220783

世界の心調律管理装置市場

Cardiac Rhythm Management Devices World Markets

発行 TriMark Publications
出版日 ページ情報 英文 250 Pages
価格
世界の心調律管理装置市場 Cardiac Rhythm Management Devices World Markets
出版日: 2011年10月01日 ページ情報: 英文 250 Pages
概要

過去50年、電子心臓医学は劇的な技術的発展を遂げました。心調律管理製品は一握りの世界的企業が販売しているもので、特に上室性不整脈(SVA)、心室性不整脈(VA)などの不整脈治療に用いられています。

当レポートでは、世界および地域別の心調律管理(CRM)製品に焦点をあて、処置費用や償還動向、製品概要などをまとめ、概略下記の内容でお届けいたします。

第1章 概要

第2章 心調律管理:概要

  • 心調律疾患
  • 律動異常
  • 心調律疾患の原因
  • 心臓突然死
  • 心調律管理装置:概要
  • ペースメーカーにおける基本的概念と用語
  • 基本的単腔ペーシング
  • 単腔ペーシングにおける追加概念
  • 二腔ペーシングの概念とモード
  • 心臓ペースメーカー購入動向
  • 埋め込み型除細動器(ICD)
  • ICDの推奨置換時期
  • 心臓再同期治療(CRT)
  • 挿入ループレコーダー(ILR)
  • 体外除細動器
  • 装着型除細動器
  • 心臓インプラントに干渉する装置
  • 将来の心臓ペースメーカーの応用
  • CRMインプラントの装置寿命
  • CRMインプラントによるクオリティオブライフ
  • CRMのコスト

第3章 CRM製品市場分析

  • 世界の心臓装置市場
  • 世界の心調律管理(CRM)装置市場
  • 世界の心臓ペースメーカー市場
  • 世界のICD市場

第4章 欧米の心調律管理シナリオ

  • 米国市場の機会
  • 米国ICD登録データ
  • カリフォルニアの45の病院における心臓移植
  • 将来の米国におけるペースメーカー埋め込み
  • 米国のICD合併率
  • 米国におけるCRT-D治療費
  • ICDインプラントの償還ガイド
  • 南米におけるICDインプラント
  • 欧州におけるペースメーカーインプラント
  • 欧州におけるCRT-Dインプラント
  • 欧州のICDインプラント
  • 欧州におけるICDおよびCRT-Dインプラント
  • 欧州のCRT-Pインプラント
  • タイプ、国別インプラントCRM装置
  • 欧米でのインプラント率の比較
  • 欧米でのCRT-DとCRT-Pインプラント率の比較
  • 欧州で用いられるペーシングモードの比率
  • 欧州のICDインプラントにおける地域的差異
  • 欧州のICD使用
  • 欧州各国のICDインプラント率
  • 欧州のICDインプラントと経済的因子
  • 欧州の二腔ICDの浸透度
  • 欧州のICDインプラントセンターの数
  • 欧州の医療因子とICDインプラント
  • 欧州のICDインプラントレシピエント
  • ESC加盟国における心臓電子生理学動向
  • 英国のCRM装置調査
  • 英国:ICD登録
  • スイスのCRM装置インプラント
  • イタリアのCRM装置インプラント
  • スペインのCRM装置インプラント
  • イスラエルのタイプ別ICDインプラント

第5章 企業プロファイル

  • Biotronik, Inc. 185
  • Biotronik's ICDs for Tachyarrhythmia
  • Cardiac Science Corporation
  • フクダ電子
  • Laerdal Medical AS
  • Medtronic, Inc.
  • 日本光電
  • Philips Healthcare
  • Schiller AG
  • Sorin Group USA, Inc.
  • St. Jude Medical, Inc.
  • Welch Allyn, Inc.
  • Zoll Medical Corporation

付録

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次

Abstract

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).

METHODOLOGY

The author of this report is a Ph.D. in biochemistry from the University of Minnesota with many decades of experience in science writing and as a medical industry analyst. He has been a senior director of several large regional and national healthcare laboratories. The editor is a retired college professor with three decades of experience in teaching biochemistry, biotechnology and pharmacology. Company-specific information is obtained mainly from industry trade publications, academic journals, news and research articles, press releases and corporate websites, as well as annual reports for publicly-held firms. Additionally, sources of information include, Heart Rhythm Society, Journal of American College of Cardiology (JACC), National Heart, Lung and Blood Institute, Berkeley Center for Health Technology, Diagnostic & Interventional Cardiology, MD Buyline, European Heart Rhythm Association (EHRA), World Society of Arrhythmia, Israel Heart Society, U.K. National Survey on Heart Diseases, European Journal of Heart Failure, Heart Rhythm Congress (HRC), The Israeli Working Group on Pacing and Electrophysiology, etc.

Some of the statistical information was taken from Biotechnology Associates' database and from TriMark's private data stores. The information in this study was obtained from sources that TriMark believes to be reliable, but do not guarantee the accuracy, adequacy or completeness of any information or omission or for the results obtained by the use of such information. Key information from the business literature was used as a basis to conduct dialogue with and obtain expert opinion from market professionals regarding commercial potential and market sizes. Senior managers from major company players were interviewed for part of the information in this report.

Table of 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 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
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