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市場調查報告書

美國的體外循環輔助下冠狀動脈繞道手術(ONCAB)用設備市場

US Market Report for On-Pump Coronary Artery Bypass Devices 2018 - MedCore

出版商 iData Research Inc. 商品編碼 590193
出版日期 內容資訊 英文 381 Pages
商品交期: 最快1-2個工作天內
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美國的體外循環輔助下冠狀動脈繞道手術(ONCAB)用設備市場 US Market Report for On-Pump Coronary Artery Bypass Devices 2018 - MedCore
出版日期: 2017年11月01日 內容資訊: 英文 381 Pages
簡介

本報告提供美國的體外循環輔助下冠狀動脈繞道手術(ONCAB)術用設備市場調查,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
    • 泵上冠狀動脈主動脈側道術用設備
    • 非體外循環冠狀動脈主動脈側道術用設備
    • 內視鏡取血管手術(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
    • 主動脈內球囊泵(IABP)用設備
    • 遠隔血液動態監測設備
    • 卵圓孔未閉合(PFO) 用設備
    • 心室中隔缺損症(VSD)·心房中隔缺損(ASD)用設備
    • 左心房封閉用設備
    • 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 體外循環輔助下冠狀動脈繞道手術(ONCAB)用設備市場

  • 簡介
  • 市場概要
  • 市場分析與預測
    • 消耗品
    • 首位灌流系統
  • 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

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目錄
Product Code: iDATA_USCS18_MC_ONCAB

The majority of coronary artery bypass graft (CABG) procedures are performed with the heart stopped. This type of procedure is termed on-pump coronary artery bypass (ONCAB) because the procedure requires the usage of a cardiopulmonary bypass (CPB). CPB is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body. The CPB pump itself is often referred to as a heart-lung machine. In addition to the heart-lung machine, a complete extracorporeal bypass system is composed of various single-use products, called disposables for the purposes of this report. As disposables come into direct contact with the patient's blood, they cannot be reused for safety reasons and must be disposed of and replaced following each procedure.

CPB is also used in heart valve replacement and repair procedures, repair of septal and congenital heart defects and transplants. However, for the purposes of this report, this chapter analyzes the use of CPB specifically in ONCAB procedures. During an ONCAB procedure, the patient's heart is stopped temporarily while surgeons use a continuous thread and hand sew vessels together to bypass the blockages. During this procedure, a mechanical cardiopulmonary bypass machine keeps the blood circulating through the body. The blood is rerouted through the healthy vessel and blood flow is restored to the heart muscle. Redirecting the blood flow to a pump enables the surgeon to clamp the aorta and stop the heart, resulting in a motionless and bloodless field. This allows the surgeon to precisely perform manual suturing to obtain accurate connections (anastomoses) between the graft vessel and the aorta, as well as effectively bypass the narrowed or obstructed coronary artery. The absence of blood flow and a motionless heart are important factors in ensuring precision and providing consistent, reproducible positive clinical outcomes.

There are some downsides to the use of CPB pumps. Use of the CPB for circulation exposes the patient's blood to foreign surfaces, which has been shown to increase the incidence of bleeding and short-term neurocognitive defects. This is known as post-perfusion syndrome or "pump head." Symptoms of post-perfusion syndrome are subtle and include defects associated with attention, concentration, short-term memory, fine motor function and speed of mental and motor responses. Additionally, stopping of the heart may damage the heart muscle. In certain studies, clamping of the aorta has been shown in certain studies to cause the release of particles into the blood stream that may produce blockages in other parts of the body, such as the brain, which may lead to neurological damage, including strokes. Despite these potential complications, the majority of CABG procedures are still performed on-pump. Furthermore, the percentage of total CABG procedures performed on-pump has been increasing year-over-year since 2004.

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

ON-PUMP CORONARY ARTERY BYPASS DEVICE MARKET 78

  • 4.1 INTRODUCTION 78
  • 4.2 MARKET OVERVIEW 80
  • 4.3 MARKET ANALYSIS AND FORECAST 83
    • 4.3.1 On-Pump Coronary Artery Bypass Disposables Market 83
    • 4.3.2 Perfusion System Market 85
  • 4.4 DRIVERS AND LIMITERS 87
    • 4.4.1 Market Drivers 87
    • 4.4.2 Market Limiters 88
  • 4.5 COMPETITIVE MARKET SHARE ANALYSIS 90

ABBREVIATIONS 93

APPENDIX: COMPANY PRESS RELEASES 96

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: On-Pump Coronary Artery Bypass Device Market by Segment, U.S., 2014 - 2024 81
  • Chart 4 2: On-Pump Coronary Artery Bypass Device Market Breakdown by Segment, U.S., 2017 82
  • Chart 4 3: On-Pump Coronary Artery Bypass Device Market Breakdown by Segment, U.S., 2024 82
  • Chart 4 4: On-Pump Coronary Artery Bypass Disposables Market, U.S., 2014 - 2024 84
  • Chart 4 5: Perfusion System Market, U.S., 2014 - 2024 86
  • Chart 4 6: Leading Competitors, On-Pump Coronary Artery Bypass Device Market, U.S., 2017 92

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: On-Pump Coronary Artery Bypass Device Market by Segment, U.S., 2014 - 2024 (US$M) 80
  • Figure 4 2: On-Pump Coronary Artery Bypass Disposables Market, U.S., 2014 - 2024 83
  • Figure 4 3: Perfusion System Market, U.S., 2014 - 2024 85
  • Figure 4 4: Drivers and Limiters, On-Pump Coronary Artery Bypass Device Market, U.S., 2017 89
  • Figure 4 5: Leading Competitors, On-Pump Coronary Artery Bypass Device Market, U.S., 2017 91
  • Figure 6 1: Press Release Summary 96
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