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米国の一時的人工心臓置換え装置市場の分析

US Market Report for Temporary Artificial Heart Replacement Devices 2018 - MedCore

発行 iData Research Inc. 商品コード 590200
出版日 ページ情報 英文 381 Pages
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米国の一時的人工心臓置換え装置市場の分析 US Market Report for Temporary Artificial Heart Replacement Devices 2018 - MedCore
出版日: 2017年11月01日 ページ情報: 英文 381 Pages
概要

当レポートでは、米国国内の一時的人工心臓置換え装置 (人工心臓デバイス) の市場について分析し、全体的な市場構造や昨今の主な出来事との関連性、市場規模の推移と見通し (過去4年間・今後7年間分)、市場促進・抑制要因、近年の企業間競争・資本取引の情勢、主要企業のプロファイルなどの情報を取りまとめてお届けいたします。

エグゼクティブ・サマリー

米国の心臓手術・心臓弁装置市場の概要

競争分析

市場の傾向

市場の発展

処置件数

分析対象の処置コード

分析対象市場

主要レポートの更新状況

過去のバージョン

分析手法

  • IDATAの9段階の分析手法

疾患概要

  • 人体構造
    • 冠動脈疾患
    • 心筋梗塞
    • 狭心症
    • 心臓弁膜症
    • うっ血性心不全

製品ポートフォリオ

  • イントロダクション
    • 組織心臓弁
    • 機械心臓弁
    • 弁形成術 (修復) 装置
    • 経カテーテル僧帽弁修復術
    • 経カテーテル心臓弁留置術
    • オンポンプ冠動脈バイパス (ONCAB) 装置
    • オフポンプ冠動脈バイパス (OPCAB) 装置
    • EVH (内視鏡下大伏在静脈摘出) デバイス
    • 吻合補助デバイス
    • 経心筋血行再建デバイス
    • 心室補助デバイス
    • 大動脈内バルーンポンプデバイス
    • 一時的人工心臓置換え装置
    • 血行力学遠隔モニタリングシステム
    • 心房中隔欠損 (ASD)/心室中隔欠損 (VSD) デバイス
    • 左心耳閉鎖装置
    • EMOM (体外式膜型人工肺)
  • FDA (米国食品医薬品局) によるリコール
    • MAQUET
    • Medtronic
    • HeartWare Inc
  • 治験動向
    • Medtronic
    • St. Jude Medical
    • Abiomed
    • Heartware Inc

一時的人工心臓置換え装置市場

  • イントロダクション
  • 市場の分析と予測
  • 市場促進・抑制要因
    • 市場促進要因
    • 市場抑制要因
  • 企業別市場シェアの分析
    • 将来的な競合企業

略語一覧

付録・各企業のプレスリリース一覧

目次
Product Code: iDATA_USCS18_MC_TAHR

Artificial heart devices can be temporary or permanent mechanical devices that are designed to replace the function of a biological heart. The term "artificial heart" should not be used for describing ventricular assist devices (VADs). VADs are pumps that assist the heart but are not designed to replace it. Instead, they are used in collaboration with a patient's heart. An artificial heart is also distinct from a cardiopulmonary bypass machine (CPB), which is an external device used for providing the functions of both the heart and lungs. CPBs are only used for a few hours at a time, most commonly during heart surgery. Artificial hearts were originally intended to be a permanent replacement for the biological human heart.

SynCardia's CardioWest™ was the world's first FDA-approved total artificial heart. It received FDA approval in October 2004 following a ten-year pivotal clinical study. The CardioWest™ was originally designed as a permanent replacement heart, but was approved as a bridge-to-transplant device for patients dying due to irreversible end-stage biventricular failure in which both the left and right ventricles of their hearts are failing. SynCardia's CardioWest™ is now marketed as the SynCardia Total Artificial Heart™. As of 2017, SynCardia's Total Artificial Heart™ has been implanted in over 1,700 cases worldwide, with over 500 implants in the United States. It is estimated to have accounted for more than 600 patient years of extended life on the device.

TABLE OF CONTENTS I

LIST OF FIGURES XII

LIST OF CHARTS XV

EXECUTIVE SUMMARY 1

U.S. CARDIAC SURGERY AND HEART VALVE DEVICE MARKET OVERVIEW 1

COMPETITIVE ANALYSIS 4

MARKET TRENDS 7

MARKET DEVELOPMENTS 11

PROCEDURE NUMBERS 12

PROCEDURE CODES INVESTIGATED 16

MARKETS INCLUDED 17

KEY REPORT UPDATES 19

VERSION HISTORY 20

RESEARCH METHODOLOGY 21

    • Step 1: Project Initiation & Team Selection 21
    • Step 2: Prepare Data Systems and Perform Secondary Research 24
    • Step 3: Preparation for Interviews & Questionnaire Design 26
    • Step 4: Performing Primary Research 27
    • Step 5: Research Analysis: Establishing Baseline Estimates 29
    • Step 6: Market Forecasts and Analysis 30
    • Step 7: Identify Strategic Opportunities 32
    • Step 8: Final Review and Market Release 33
    • Step 9: Customer Feedback and Market Monitoring 34

DISEASE OVERVIEW 35

  • 2.1 BASIC ANATOMY 35
    • 2.1.11 Coronary Artery Disease 37
    • 2.1.12 Myocardial Infarction 37
    • 2.1.13 Angina Pectoris 38
    • 2.1.14 Heart Valve Disease 39
    • 2.1.15 Congestive Heart Failure 39

PRODUCT PORTFOLIO 41

    • 3.1.1 Tissue Heart Valves 41
    • 3.1.2 Mechanical Tissue Heart Valves 43
    • 3.1.3 Annuloplasty Repair Devices 45
    • 3.1.4 Transcatheter Aortic Valve Replacement Devices 47
    • 3.1.5 Transcatheter Mitral Valve Repair Devices 49
    • 3.1.6 On-Pump Coronary Artery Bypass Devices 50
    • 3.1.7 Off-Pump Coronary Artery Bypass Devices 52
    • 3.1.8 Endoscopic Vessel Harvesting Devices 53
    • 3.1.9 Anastomosis Assist Devices 54
    • 3.1.10 Transmyocardial Revascularization Devices 55
    • 3.1.11 Ventricular Assist Devices 56
    • 3.1.12 Intra-Aortic Balloon Pump Device 57
    • 3.1.13 Temporary Artificial Heart Replacement Device 58
    • 3.1.14 Remote Hemodynamic Monitoring System Devices 59
    • 3.1.15 Patent Foramen Ovale Devices 59
    • 3.1.16 Atrial & Ventricular Septal Defect Device 61
    • 3.1.17 Left Atrial Appendage Closure Device 62
    • 3.1.18 Extracorporeal Membrane Oxygenation Machine 63
  • 3.2 FDA RECALLS 64
    • 3.2.1 MAQUET 64
    • 3.2.2 Medtronic 66
    • 3.2.3 HeartWare Inc 67
  • 3.3 CLINICAL TRIALS 68
    • 3.3.1 Medtronic 68
    • 3.3.2 St. Jude Medical 70
    • 3.3.3 Abiomed 75
    • 3.3.4 Heartware Inc 76

TEMPORARY ARTIFICIAL HEART REPLACEMENT DEVICE MARKET 78

  • 4.1 INTRODUCTION 78
  • 4.2 MARKET ANALYSIS AND FORECAST 80
  • 4.3 DRIVERS AND LIMITERS 83
    • 4.3.1 Market Drivers 83
    • 4.3.2 Market Limiters 84
  • 4.4 COMPETITIVE MARKET SHARE ANALYSIS 86
    • 4.4.1 Potential Competitors 88

ABBREVIATIONS 89

APPENDIX: COMPANY PRESS RELEASES 92

LIST OF CHARTS

  • Chart 1 1: Cardiac Surgery and Heart Valve Devices Market by Segment, U.S., 2014 - 2024 3
  • Chart 1 2: Cardiac Surgery and Heart Valve Devices Market Overview, U.S., 2017 & 2024 3
  • Chart 4 1: Temporary Artificial Heart Replacement Device Market, U.S., 2014 - 2024 82
  • Chart 4 2: Leading Competitors, Temporary Artificial Heart Replacement Device Market, U.S., 2017 87

LIST OF FIGURES

  • Figure 1 1: Cardiac Surgery and Heart Valve Devices Market Share Ranking by Segment, U.S., 2017 (1 of 4) 4
  • Figure 1 2: Cardiac Surgery and Heart Valve Devices Market Share Ranking by Segment, U.S., 2017 (2 of 4) 5
  • Figure 1 3: Cardiac Surgery and Heart Valve Devices Market Share Ranking by Segment, U.S., 2017 (3 of 4) 5
  • Figure 1 4: Cardiac Surgery and Heart Valve Devices Market Share Ranking by Segment, U.S., 2017 (4 of 4) 5
  • Figure 1 5: Companies Researched in this Report, U.S., 2017 6
  • Figure 1 6: Factors Impacting the Cardiac Surgery and Heart Valve Devices Market by Segment, U.S. (1 of 4) 7
  • Figure 1 7: Factors Impacting the Cardiac Surgery and Heart Valve Devices Market by Segment, U.S. (2 of 4) 8
  • Figure 1 8: Factors Impacting the Cardiac Surgery and Heart Valve Devices Market by Segment, U.S. (3 of 4) 9
  • Figure 1 9: Factors Impacting the Cardiac Surgery and Heart Valve Devices Market by Segment, U.S. (4 of 4) 10
  • Figure 1 10: Recent Events in the Cardiac Surgery and Heart Valve Devices Market, U.S., 2015 - 2017 11
  • Figure 1 11: Cardiac Surgery and Heart Valve Devices Procedures Covered, U.S., 2017 (1 of 4) 12
  • Figure 1 12: Cardiac Surgery and Heart Valve Devices Procedures Covered, U.S., 2017 (2 of 4) 13
  • Figure 1 13: Cardiac Surgery and Heart Valve Devices Procedures Covered, U.S., 2017 (3 of 4) 14
  • Figure 1 14: Cardiac Surgery and Heart Valve Devices Procedures Covered, U.S., 2017 (4 of 4) 15
  • Figure 1 15: Procedure Codes Investigated, U.S., 2017 16
  • Figure 1 16: Cardiac Surgery and Heart Valve Devices Markets Covered, U.S., 2017 (1 of 2) 17
  • Figure 1 17: Cardiac Surgery and Heart Valve Devices Markets Covered, U.S., 2017 (2 of 2) 18
  • Figure 1 18: Key Report Updates (1 of 2) 19
  • Figure 1 19: Key Report Updates (2 of 2) 20
  • Figure 1 20: Version History 20
  • Figure 3 1: Tissue Heart Valves by Company 42
  • Figure 3 2: Mechanical Tissue Heart Valves by Company 44
  • Figure 3 3: Annuloplasty Repair Devices by Company 46
  • Figure 3 4: Transcatheter Heart Valve Replacement Devices by Company 48
  • Figure 3 5: Transcatheter Mitral Valve Repair Devices by Company 49
  • Figure 3 6: On-Pump Coronary Artery Bypass Devices by Company 51
  • Figure 3 7: Off-Pump Coronary Artery Bypass Devices by Company 52
  • Figure 3 8: Endoscopic Vessel Harvesting Devices by Company 53
  • Figure 3 9: Anastomosis Assist Devices by Company 54
  • Figure 3 10: Transmyocardial Revascularization Devices by Company 55
  • Figure 3 11: Ventricular Assist Devices by Company 56
  • Figure 3 12: Intra-Aortic Balloon Devices by Company 57
  • Figure 3 13: Temporary Artificial Heart Replacement Devices by Company 58
  • Figure 3 14: Remote Hemodynamic Monitoring System Devices by Company 59
  • Figure 3 15: Patent Foramen Ovale Devices by Company 60
  • Figure 3 16: Atrial & Ventricular Septal Defect Devices by Company 61
  • Figure 3 17: Left Atrial Appendage Closure Devices by Company 62
  • Figure 3 18: Extracorporeal Membrane Oxygenation Machine by Company 63
  • Figure 3 19: Class 2 Device Recall MAQUET 64
  • Figure 3 20: Class 2 Device Recall MAQUET 64
  • Figure 3 21: Class 2 Device Recall MAQUET 65
  • Figure 3 22: Class 1 Device Recall Medtronic 66
  • Figure 3 23: Class 1 Device Recall Heartware Inc 67
  • Figure 3 24: The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study 68
  • Figure 3 25: Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance 68
  • Figure 3 26: Medtronic CoreValve Evolut R U.S. Clinical Study 69
  • Figure 3 27: Medtronic Transcatheter Aortic Valve Replacement in Low Risk Patients 69
  • Figure 3 28: AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption 70
  • Figure 3 29: AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) 70
  • Figure 3 30: HeartMate 3 CE Mark Study Long Term Follow-up (HM3 CE LTFU) 71
  • Figure 3 31: Trifecta™ GT Post Market Clinical Follow-up 71
  • Figure 3 32: AMPLATZER™ LAA Occluder Post Approval Study (PAS) 72
  • Figure 3 33: AMPLATZER™ Cardiac Plug Observational Post-Approval Study (ACP PAS China) 72
  • Figure 3 34: MOMENTUM 3 Continued Access Protocol (MOMENTUM 3 CAP) 73
  • Figure 3 35: AMPLATZER™ Amulet™ LAA Occluder Trial (Amulet IDE) 73
  • Figure 3 36: Prevention of Non-Surgical Bleeding by Management of HeartMate II 74
  • Figure 3 37: Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction (DTU) 75
  • Figure 3 38: Protected PCI Study 75
  • Figure 3 39: Assessment of the WATCHMAN™ Device 76
  • Figure 3 40: Watchman FLX Left Atrial Appendage Closure Device Post Approval Study 76
  • Figure 3 41: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology 77
  • Figure 4 1: Temporary Artificial Heart Replacement Device Market, U.S., 2014 - 2024 81
  • Figure 4 2: Drivers and Limiters, Temporary Artificial Heart Replacement Device Market, U.S., 2017 85
  • Figure 4 3: Leading Competitors, Temporary Artificial Heart Replacement Device Market, U.S., 2017 86
  • Figure 6 1: Press Release Summary 92
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