美國的左心耳封閉設備市場

本報告提供美國的左心耳封閉設備市場調查，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 美國的左心耳封閉設備市場

• 簡介
• 市場分析與預測
  • 心外膜影片剪輯
  • 心外膜縫合線
• 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

The left atrial appendage (LAA) is a small pouch in the wall of the left atrium. It is unknown what function the LAA performs.

In patients with normal heart rhythm, the heart contracts with each heartbeat. As the heart contracts, blood is pushed from the left atrial appendage into the left atrium and from the left atrium into the left ventricle.

Atrial fibrillation (AF) is an abnormal heart rhythm. Patients with AF experience episodes of rapid and irregular beating. As a result of irregular beating, the atrium in AF patients does not completely contract, impeding the flow of blood from the atria into the ventricles. Blood that is not expelled from the left atria collects in the sac-shaped LAA. Once in the LAA, movement of the blood slows. As blood slows, it tends to clot. Strokes can be caused when blood clots are pumped out of the heart. As a result of increased blood clot formation, AF patients are five to seven times more likely to suffer a stroke than those without AF.

Some patients with AF take a blood thinner, such as warfarin (Coumadin), to reduce the risk of stroke. However, many AF patients dislike taking warfarin due to the increased risk of bleeding, the need to limit vitamin K intake and the increased need for blood draws to measure their international normalized ratio (INR). LAA closure devices were developed as an alternative method of reducing the risk of stroke in AF patients. LAA closure devices are used to seal off the LAA, preventing clot formation in the LAA and eliminating the need for the patient to take blood-thinning medication.

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

LEFT ATRIAL APPENDAGE CLOSURE DEVICE MARKET 78

• 4.1 INTRODUCTION 78
• 4.2 MARKET OVERVIEW 80
• 4.3 MARKET ANALYSIS AND FORECAST 84
• 4.3.1 Epicardial Device Market 84
• 4.3.1.1 Epicardial Clip Device Market 87
• 4.3.1.1.1 Open Epicardial Clip Device Market 89
• 4.3.1.1.2 MIS Epicardial Clip Device Market 91
• 4.3.1.2 Epicardial Suture Device Market 93
• 4.3.2 Endocardial Device Market 95
• 4.4 DRIVERS AND LIMITERS 97
• 4.4.1 Market Drivers 97
• 4.4.2 Market Limiters 97
• 4.5 COMPETITIVE MARKET SHARE ANALYSIS 99
• 4.5.1 Potential Competitors 101

ABBREVIATIONS 102

APPENDIX: COMPANY PRESS RELEASES 105

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: Left Atrial Appendage Closure Device Market by Segment, U.S., 2014 - 2024 82
• Chart 4 2: Left Atrial Appendage Closure Device Market Breakdown by Segment, U.S., 2017 83
• Chart 4 3: Left Atrial Appendage Closure Device Market Breakdown by Segment, U.S., 2024 83
• Chart 4 4: Epicardial Device Market by Segment, U.S., 2014 - 2024 85
• Chart 4 5: Epicardial Device Market Breakdown by Segment, U.S., 2017 86
• Chart 4 6: Epicardial Device Market Breakdown by Segment, U.S., 2024 86
• Chart 4 7: Epicardial Clip Device Market, U.S., 2014 - 2024 88
• Chart 4 8: Open Epicardial Clip Device Market, U.S., 2014 - 2024 90
• Chart 4 9: MIS Epicardial Clip Device Market, U.S., 2014 - 2024 92
• Chart 4 10: Epicardial Suture Device Market, U.S., 2014 - 2024 94
• Chart 4 11: Endocardial Device Market, U.S., 2014 - 2024 96
• Chart 4 12: Leading Competitors, Left Atrial Appendage Closure Device Market, U.S., 2017 100

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: Left Atrial Appendage Closure Device Market by Segment, U.S., 2014 - 2024 (US$M) 81
• Figure 4 2: Epicardial Device Market by Segment, U.S., 2014 - 2024 (US$M) 84
• Figure 4 3: Epicardial Clip Device Market, U.S., 2014 - 2024 87
• Figure 4 4: Open Epicardial Clip Device Market, U.S., 2014 - 2024 89
• Figure 4 5: MIS Epicardial Clip Device Market, U.S., 2014 - 2024 91
• Figure 4 6: Epicardial Suture Device Market, U.S., 2014 - 2024 93
• Figure 4 7: Endocardial Device Market, U.S., 2014 - 2024 95
• Figure 4 8: Drivers and Limiters, Left Atrial Appendage Closure Device Market, U.S., 2017 98
• Figure 4 9: Leading Competitors, Left Atrial Appendage Closure Device Market, U.S., 2017 99
• Figure 6 1: Press Release Summary 105