米国のECMO (体外式膜型人工肺) 市場の分析

当レポートでは、米国国内の体外式膜型人工肺 (ECMO) 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
  • ECMO (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

ECMO (体外式膜型人工肺) 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

略語一覧

付録・各企業のプレスリリース一覧

The ECMO market includes disposable products and capital equipment. ECMO products have been in the market for a long time but have only recently started gaining traction. ECMO has experienced a reinvigoration due to positive reports and the stagnation of heart-lung machines in the market. The market is expected to grow as more surgeons view the technique as a better alternative to heart-lung machines.

Extracorporeal membrane oxygenation (ECMO) is used as a support device for use in heart failure. ECMO is a miniaturized and simplified form of heart-lung machines. ECMO involves withdrawing venous blood with an active pump and returning oxygenated blood into a major central artery. ECMO is primarily used for patients who need cardiac and lung support. ECMO is divided into three types: veno-arterial (VA), veno-venous (VV) and arteriovenous (AV). VA is used for support during cardiac failure. The blood is drained from a large central vein, into an oxygenator and re-enters the arterial system at the aorta. VA is generally done as a bridge to left ventricular assist device replacement. VV is the most common mode of ECMO done and is generally utilized for support during respiratory failure. VV is not used for cardiac failure and is a bridge to lung transplant.

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

EXTRACORPOREAL MEMBRANE OXYGENATION MACHINE MARKET 78

• 4.1 INTRODUCTION 78
• 4.2 MARKET ANALYSIS AND FORECAST 79
• 4.3 DRIVERS AND LIMITERS 81
• 4.3.1 Market Drivers 81
• 4.3.2 Market Limiters 81
• 4.4 COMPETITIVE MARKET SHARE ANALYSIS 82

ABBREVIATIONS 83

APPENDIX: COMPANY PRESS RELEASES 86

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: Extracorporeal Membrane Oxygenation Machine Market, U.S., 2014 - 2024 80

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: Extracorporeal Membrane Oxygenation Machine Market, U.S., 2014 - 2024 (US$M) 79
• Figure 4 2: Drivers and Limiters, Extracorporeal Membrane Oxygenation Machine Market, U.S., 2017 81
• Figure 6 1: Press Release Summary 86