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市場調査レポート

米国の卵円孔開存症(PFO)用デバイス市場

US Market Report for Patent Foramen Ovale Devices 2018 - MedCore

発行 iData Research Inc. 商品コード 590202
出版日 ページ情報 英文 379 Pages
納期: 即日から翌営業日
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米国の卵円孔開存症(PFO)用デバイス市場 US Market Report for Patent Foramen Ovale Devices 2018 - MedCore
出版日: 2017年11月01日 ページ情報: 英文 379 Pages
概要

当レポートでは、米国の卵円孔開存症(PFO)用デバイス市場を調査し、市場および疾患の概要、各種製品の評価、治験・リコールの状況、市場促進・阻害要因の分析、企業の市場シェアなどについて包括的にまとめています。

目次

図表

エグゼクティブサマリー

米国の心臓手術および心臓弁市場

競合分析

市場動向

市場発展

処置件数

調査対象医療コード

調査対象市場

更新情報

改訂履歴

第1章 調査手法

第2章 疾病概要

  • 基本構造
    • 冠動脈疾患
    • 心筋梗塞
    • 狭心症
    • 心臓弁疾患
    • 鬱血性心不全

第3章 製品ポートフォリオ

  • 製品ポートフォリオ
    • 生体弁
    • 機械弁
    • 弁輪形成術用デバイス
    • 経カテーテル大動脈弁置換術(TAVR)用デバイス
    • 経カテーテル僧帽弁修復術用デバイス
    • オンポンプ冠動脈バイパス術(ONCAB)用デバイス
    • オフポンプ冠動脈バイパス術(OPCAB)用デバイス
    • 内視鏡下血管採取術(EVH)用デバイス
    • 血管吻合補助デバイス
    • 心筋内血行再建術用デバイス
    • 補助人工心臓
    • 大動脈内バルーンパンピング術(IABP)用デバイス
    • 遠隔血液動態モニタリングデバイス
    • 卵円孔開存症(PFO)用デバイス
    • 心室中隔欠損症(VSD)・心房中隔欠損(ASD)用デバイス
    • 左心耳閉鎖用デバイス
    • 体外式膜型人工肺
  • FDAによるリコール
  • 治験

第4章 卵円孔開存症(PFO)用デバイス市場

  • イントロダクション
  • 市場分析と予測
  • 市場促進・阻害要因
    • 市場促進要因
    • 市場阻害要因
  • 市場シェアの分析

略語一覧

付録:企業のプレスリリース

目次
Product Code: iDATA_USCS18_MC_PFO

A patent foramen ovale (PFO) is a defect in the septum between the two atrial chambers of the heart. Specifically, the defect is an incomplete closure of the atrial septum that results in the creation of a flap or a valve-like opening in the atrial septal wall. A PFO is distinct from a secundum atrial septal defect (ASD). A PFO is present in everyone before birth but seals shut in most people. In adults, PFO occurs when the atrial septum, which is responsible for recycling blood during womb development, does not properly occlude after birth. The condition is very common, affecting over 20% of the population. Individuals with PFO are more likely to suffer a stroke and there is evidence that migraines can be a symptom of the condition. Those who have a PFO as well as migraines often experience sensations during their migraine that include shimmering spots, blurred vision and blind spots. There are many cases where PFO patients do not need to undergo surgery and drug treatment and continual monitoring are the only measures that are necessary. However, open surgical and interventional procedures are common in patients who run the risk of having a sudden cardiac arrest.

Some studies have suggested that PFO closure can reduce the incidence of migraine headaches. While surgery would be considered too risky a treatment for the vast majority of migraine sufferers, these patients represent a large potential market for a less invasive percutaneous procedure. As a result, a number of clinical trials including the PREMIUM, PRIMA, CLOSURE I, ESCAPE, MIST I and MIST II clinical trials were created to investigate the use of PFO devices in treating patients with severe migraines. There are additional studies that have focused on migraine patients that have experienced stroke in the past and therefore may not be representative of otherwise healthy migraine patients. It is probable that PFOs contribute to certain types of migraines and PFO closure would be a suitable treatment for only a percentage of PFO patients.

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

PATENT FORAMEN OVALE DEVICE MARKET 78

  • 4.1 INTRODUCTION 78
  • 4.2 MARKET ANALYSIS AND FORECAST 80
  • 4.3 DRIVERS AND LIMITERS 82
    • 4.3.1 Market Drivers 82
    • 4.3.2 Market Limiters 82
  • 4.4 COMPETITIVE MARKET SHARE ANALYSIS 84
    • 4.4.1 Potential Competitors 86

ABBREVIATIONS 87

APPENDIX: COMPANY PRESS RELEASES 90

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: Patent Foramen Ovale Device Market, U.S., 2014 - 2024 81
  • Chart 4 2: Leading Competitors, Patent Foramen Ovale Device Market, U.S., 2017 85

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: Patent Foramen Ovale Device Market, U.S., 2014 - 2024 80
  • Figure 4 2: Drivers and Limiters, Patent Foramen Ovale Device Market, U.S., 2017 83
  • Figure 4 3: Leading Competitors, Patent Foramen Ovale Device Market, U.S., 2017 84
  • Figure 6 1: Press Release Summary 90
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