美國的心房中膈缺損症(ASD)及心室中隔缺損症(VSD)用設備市場

本報告提供美國的心房中膈缺損症(ASD)及心室中隔缺損症(VSD)用設備市場調查，總括性彙整市場及疾病概要，各種產品的評估，臨床實驗·回收狀況，市場促進·阻礙因素分析，企業的市場佔有率等資訊。

目錄

圖表

摘要整理

美國的心血管手術及心臟瓣膜市場

競爭分析

市場趨勢

市場發展

治療數量

調查對象醫療編碼

調查對象市場

更新資訊

修訂履歷

第1章 調查手法

第2章 疾病概要

• 基本結構
  • 冠狀動脈疾病
  • 心肌梗塞
  • 心絞痛
  • 心臟瓣膜疾病
  • 鬱血性心衰竭

第3章 產品系列

• 產品系列
  • 生物學心臟瓣膜
  • 機械瓣膜
  • 瓣環成形術術用設備
  • 經導管主動脈瓣置換術(TAVR)用設備
  • 經導管二尖瓣瓣膜修復術用設備
  • 體外循環輔助下冠狀動脈繞道手術術(ONCAB)用設備
  • 非體外循環冠狀動脈繞道手術術(OPCAB)用設備
  • 內視鏡取血管手術術(EVH)用設備
  • 血管吻合補助設備
  • 心肌內血液循環重組術用設備
  • 輔助人工心臟
  • 主動脈內球囊麵包ping術(IABP)用設備
  • 遠隔血液動態監測設備
  • 卵圓孔未閉合症(PFO)用設備
  • 心房中膈缺損症(ASD)及心室中隔缺損症(VSD)用設備
  • 左心耳封閉用設備
  • 體外式薄膜型人工肺
• FDA的回收
  • MAQUET
  • Medtronic
  • HeartWare Inc
• 臨床實驗
  • Medtronic
  • St. Jude Medical
  • Abiomed
  • Heartware Inc

第4章 心房中膈缺損症(ASD)及心室中隔缺損症(VSD)用設備市場

• 簡介
• 市場分析與預測
  • 心房中膈缺損症(ASD)及心室中隔缺損症(VSD)用設備市場
  • 心房中膈缺損症(ASD)用設備市場
  • 心室中隔缺損症(VSD)用設備市場
• 市場促進·阻礙因素
  • 推動市場要素
  • 市場阻礙因素
• 市場佔有率分析

簡稱一覽

附錄:企業的新聞稿

Atrial septal defect (ASD) and ventricular septal defect (VSD) are both conditions that involve incorrect blood flow within the heart. ASD is an opening in the muscular tissue that separates the sides of the heart's two upper chambers. Due to blood reflux, the heart is made to work more strenuously and below its optimal level. The condition is more common in females than males and tends to get worse with time. If left untreated, ASD can cause hypertension, heart arrhythmia and even a stroke. As with patent foramen ovale (PFO), ASD can be treated with open-heart surgery, but the operation is highly invasive. ASDs are found in approximately 1 in 1,500 live births and can lead to death if not treated in some cases.

VSDs are defects in the ventricular septum, the wall dividing the left and right ventricles of the heart. VSDs are similar to ASDs but tend to cause fewer complications because VSDs are small and most people with the defect barely feel the symptoms. However, approximately 10% of individuals with VSD will develop Eisenmenger's Syndrome, which is a condition that can curtail life expectancy by several years. This condition can also be found in ASD patients. VSDs are found in approximately 3 to 3.5 of every 1,000 births but the vast majority of VSDs are likely to close spontaneously during childhood. Only in a small percentage of cases, they will have to be treated surgically. ASDs and VSDs can be treated percutaneously by inserting a device through the defect, which expands and forms a seal around the defect. Many of these devices allow heart tissue to grow over the device with time.

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

ATRIAL AND VENTRICULAR SEPTAL DEFECT DEVICE MARKET 78

• 4.1 INTRODUCTION 78
• 4.2 MARKET OVERVIEW 79
• 4.3 MARKET ANALYSIS AND FORECAST 82
• 4.3.1 Total Atrial and Ventricular Septal Defect Device Market 82
• 4.3.2 Atrial Septal Defect Device Market 84
• 4.3.3 Ventricular Septal Defect Device Market 86
• 4.4 DRIVERS AND LIMITERS 88
• 4.4.1 Market Drivers 88
• 4.4.2 Market Limiters 88
• 4.5 COMPETITIVE MARKET SHARE ANALYSIS 90

ABBREVIATIONS 92

APPENDIX: COMPANY PRESS RELEASES 95

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: Atrial and Ventricular Septal Defect Device Market by Segment, U.S., 2014 - 2024 80
• Chart 4 2: Atrial and Ventricular Septal Defect Device Market Breakdown by Segment, U.S., 2017 81
• Chart 4 3: Atrial and Ventricular Septal Defect Device Market Breakdown by Segment, U.S., 2024 81
• Chart 4 4: Total Atrial and Ventricular Septal Defect Device Market, U.S., 2014 - 2024 83
• Chart 4 5: Atrial Septal Defect Device Market, U.S., 2014 - 2024 85
• Chart 4 6: Ventricular Septal Defect Device Market, U.S., 2014 - 2024 87
• Chart 4 7: Leading Competitors, Atrial and Ventricular Septal Defect Device Market, U.S., 2017 91

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: Atrial and Ventricular Septal Defect Device Market by Segment, U.S., 2014 - 2024 (US$M) 79
• Figure 4 2: Total Atrial and Ventricular Septal Defect Device Market, U.S., 2014 - 2024 82
• Figure 4 3: Atrial Septal Defect Device Market, U.S., 2014 - 2024 84
• Figure 4 4: Ventricular Septal Defect Device Market, U.S., 2014 - 2024 86
• Figure 4 5: Drivers and Limiters, Atrial and Ventricular Septal Defect Device Market, U.S., 2017 89
• Figure 4 6: Leading Competitors, Atrial and Ventricular Septal Defect Device Market, U.S., 2017 90
• Figure 6 1: Press Release Summary 95