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市場調查報告書

美國的心臟瓣膜 (生物學心臟瓣膜) 市場

US Market Report for Tissue Heart Valves 2018 - MedCore

出版商 iData Research Inc. 商品編碼 590188
出版日期 內容資訊 英文 395 Pages
商品交期: 最快1-2個工作天內
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美國的心臟瓣膜 (生物學心臟瓣膜) 市場 US Market Report for Tissue Heart Valves 2018 - MedCore
出版日期: 2017年11月01日 內容資訊: 英文 395 Pages
簡介

本報告提供美國的心臟瓣膜 (生物學心臟瓣膜) 市場相關調查分析,疾病概要,產品的評估,市場分析等相關的系統性資訊。

摘要整理

美國的心血管手術和心臟瓣膜設備市場概要

競爭分析

市場趨勢

市場發展

治療數量

調查對象的醫療編碼

對象市場

主要的調查更新

版本履歷

第1章 調查手法

第2章 疾病概要

  • 基本結構

第3章 產品系列

  • 產品系列
  • FDA回收
  • 臨床實驗

第4章 心臟瓣膜 (生物學心臟瓣膜) 市場

  • 簡介
  • 市場概要
  • 市場分析與預測
  • 促進因素及阻礙因素
    • 推動市場要素
    • 市場阻礙因素
  • 競爭市場佔有率分析

簡稱

附錄

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目錄
Product Code: iDATA_USCS18_MC_THV

Tissue valves, which are also known as bioprosthetic valves, are harvested from either human donors or animal tissue. Human tissue valves can either be obtained from donor cadavers in allograft procedures, or from one's own body in an autograft procedure. Allograft valves may be acquired from deceased family members or anonymous donors. Autograft valves may be obtained through a Ross procedure, whereby part of the pulmonary valve is grafted and harvested into the aortic position. Whether autograft or allograft, human donor valves involve complicated extraction and insertion procedures. Human tissue valves are in limited supply and typically do not function drastically better than xenograft valves.

The vast majority of commercially available tissue valves are xenograft valves derived from animals. Usually, the valves are porcine, meaning from a pig, or bovine, meaning from a cow. The porcine heart is most similar to the human heart and therefore represents the best anatomical fit for replacement. The tissue of the pericardial sac is particularly well suited for a valve leaflet due to its extremely durable physical properties. Before implantation, the tissue undergoes multiple chemical treatments to make it suitable for replacement in the human heart. The tissue is sterilized so that the biological markers are removed, thereby eliminating a response from the host's immune system. The primary advantage of tissue over mechanical valves is that tissue valves are much more biocompatible and thus a patient who receives a tissue valve does not require life-long anti-coagulation therapy. However, a disadvantage of tissue valves is that they are not as durable and typically last between 15 and 20 years before requiring replacement. Nevertheless, advances in polymer coatings have made tissue valves more durable than ever before. Furthermore, several aortic tissue valve replacement devices under development that are currently undergoing clinical trials in the U.S. or awaiting FDA approval may be implanted percutaneously.

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

TISSUE HEART VALVE MARKET 78

  • 4.1 INTRODUCTION 78
  • 4.2 MARKET OVERVIEW 80
    • 4.2.1 Tissue Heart Valve Market by Device Type 81
    • 4.2.2 Tissue Heart Valve Market by Tissue Type 84
  • 4.3 MARKET ANALYSIS AND FORECAST 87
    • 4.3.1 Total Tissue Heart Valve Market 87
    • 4.3.2 Total Tissue Heart Valve Market by Device Type 89
      • 4.3.2.1 Stented Tissue Heart Valve Market 89
      • 4.3.2.2 Stentless Tissue Heart Valve Market 91
      • 4.3.2.3 Sutureless Tissue Heart Valve Market 93
    • 4.3.3 Total Tissue Heart Valve Market by Tissue 94
      • 4.3.3.1 Xenograft Tissue Heart Valve Market 94
      • 4.3.3.2 Allograft Tissue Heart Valve Market 96
  • 4.4 DRIVERS AND LIMITERS 98
    • 4.4.1 Market Drivers 98
    • 4.4.2 Market Limiters 99
  • 4.5 COMPETITIVE MARKET SHARE ANALYSIS 100

ABBREVIATIONS 103

APPENDIX: COMPANY PRESS RELEASES 106

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: Tissue Heart Valve Market by Device Type, U.S., 2014 - 2024 82
  • Chart 4 2: Tissue Heart Valve Market Breakdown by Device Type, U.S., 2017 83
  • Chart 4 3: Tissue Heart Valve Market Breakdown by Device Type, U.S., 2024 83
  • Chart 4 4: Tissue Heart Valve Market by Tissue Type, U.S., 2014 - 2024 85
  • Chart 4 5: Tissue Heart Valve Market Breakdown by Tissue Type, U.S., 2017 86
  • Chart 4 6: Tissue Heart Valve Market Breakdown by Tissue Type, U.S., 2024 86
  • Chart 4 7: Total Tissue Heart Valve Market, U.S., 2014 - 2024 88
  • Chart 4 8: Stented Tissue Heart Valve Market, U.S., 2014 - 2024 90
  • Chart 4 9: Stentless Tissue Heart Valve Market, U.S., 2014 - 2024 92
  • Chart 4 10: Xenograft Tissue Heart Valve Market, U.S., 2014 - 2024 95
  • Chart 4 11: Allograft Tissue Heart Valve Market, U.S., 2014 - 2024 97
  • Chart 4 12: Leading Competitors, Tissue Heart Valve Market, U.S., 2017 102

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: Tissue Heart Valve Market by Device Type, U.S., 2014 - 2024 (US$M) 81
  • Figure 4 2: Tissue Heart Valve Market by Tissue Type, U.S., 2014 - 2024 (US$M) 84
  • Figure 4 3: Total Tissue Heart Valve Market, U.S., 2014 - 2024 87
  • Figure 4 4: Stented Tissue Heart Valve Market, U.S., 2014 - 2024 89
  • Figure 4 5: Stentless Tissue Heart Valve Market, U.S., 2014 - 2024 91
  • Figure 4 6: Xenograft Tissue Heart Valve Market, U.S., 2014 - 2024 94
  • Figure 4 7: Allograft Tissue Heart Valve Market, U.S., 2014 - 2024 96
  • Figure 4 8: Drivers and Limiters, Tissue Heart Valve Market, U.S., 2017 99
  • Figure 4 9: Leading Competitors, Tissue Heart Valve Market, U.S., 2017 101
  • Figure 6 1: Press Release Summary 106
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