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미국의 보조인공심장(VAD) 시장

US Market Report for Ventricular Assist Devices 2018 - MedCore

리서치사 iData Research Inc.
발행일 2017년 11월 상품 코드 590198
페이지 정보 영문 381 Pages
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미국의 보조인공심장(VAD) 시장 US Market Report for Ventricular Assist Devices 2018 - MedCore
발행일 : 2017년 11월 페이지 정보 : 영문 381 Pages

이 페이지에 게재되어 있는 내용은 최신판과 약간 차이가 있을 수 있으므로 영문목차를 함께 참조하여 주시기 바랍니다. 기타 자세한 사항은 문의 바랍니다.

한글목차

미국의 보조인공심장(VAD) 시장에 대해 조사분석했으며, 질환 개요, 제품 평가, 시장 분석에 관한 정보를 정리하여 전해드립니다.

개요

미국의 심장 수술과 심장판막 디바이스 시장 개요

경쟁 분석

시장 동향

시장의 발전

시술 건수

조사 대상 의료 코드

대상 시장

주요 조사 업데이트

버전 이력

제1장 조사 방법

제2장 질환 개요

  • 기본 구조

제3장 제품 포트폴리오

  • 제품 포트폴리오
  • FDA 리콜
  • 임상시험

제4장 보조인공심장(VAD) 시장

  • 서론
  • 시장 개요
  • 시장 분석과 예측
  • 유닛 분석과 예측
  • 촉진요인과 저해요인
    • 시장 성장 촉진요인
    • 시장 성장 저해요인
  • 경쟁 시장 점유율 분석

약어

부록

KSA 17.12.20

영문목차

Ventricular assist devices (VADs) are used for aiding a failing heart by supplementing the pumping function of the heart. VADs are often used in patients with advanced heart failure (HF). HF is a chronic disease that occurs when degeneration of the heart muscle reduces the pump power of the heart, which causes the heart to become too weak to pump blood at a level sufficient to meet the body's demands. The condition may be caused by arterial and valve diseases or cardiomyopathy, which is disease of the heart muscle itself. Other conditions such as high blood pressure or diabetes may also lead to HF.

The American Heart Association (AHA) estimates that 5.1 million people suffer from HF in the U.S. and approximately 550,000 new cases are diagnosed each year. Pharmacologic therapies remain the most widely used approach for treatment of HF but heart transplantation remains the only curative option for late stages of the disease. Other procedures to treat HF include angioplasty, biventricular pacing, valve replacement, bypass and left ventricular reduction surgery.

VADs are designed to assist either the left (LVAD), the right (RVAD) ventricle, or both at the same time (BiVAD). The choice of device depends on the underlying heart disease and the pulmonary arterial resistance that determines the load on the right ventricle. LVADs are by far the most commonly performed procedures but when pulmonary resistance is high, right ventricular assist becomes necessary. Biventricular assist devices supply circulatory support to both the right and left ventricle of the heart, by pumping blood to both the systemic and pulmonary systems. Being an assist device, a BiVAD functions in conjunction with the native heart, unlike a total artificial heart with which the native heart is removed. By retaining the native ventricles of the heart, a BiVAD allows for the possibility of myocardial recovery, which would eliminate the need for cardiac transplantation. For the purpose of this report, VADs are segmented into three categories: percutaneous ventricular assist devices (pVADs), implantable ventricular assist devices and external ventricular assist devices. Implantable VADs are used for bridge-to-recovery (BTR), bridge-to-transplant (BTT) and destination therapy (DT). These labels are described briefly below.

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

VENTRICULAR ASSIST DEVICE MARKET 78

  • 4.1 INTRODUCTION 78
  • 4.2 MARKET OVERVIEW 81
  • 4.3 MARKET ANALYSIS AND FORECAST 84
    • 4.3.1 Percutaneous Ventricular Assist Device Market 84
    • 4.3.2 Implantable Ventricular Assist Device Market 86
    • 4.3.3 External Ventricular Assist Device Market 88
      • 4.3.3.1 Short Term External Ventricular Assist Device Market 91
      • 4.3.3.2 Long Term External Ventricular Assist Device Market 93
  • 4.4 UNIT ANALYSIS AND FORECAST 95
  • 4.5 DRIVERS AND LIMITERS 97
    • 4.5.1 Market Drivers 97
    • 4.5.2 Market Limiters 98
  • 4.6 COMPETITIVE MARKET SHARE ANALYSIS 99
    • 4.6.1 Potential Competitors 102

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: Ventricular Assist Device Market by Segment, U.S., 2014 - 2024 82
  • Chart 4 2: Ventricular Assist Device Market Breakdown by Segment, U.S., 2017 83
  • Chart 4 3: Ventricular Assist Device Market Breakdown by Segment, U.S., 2024 83
  • Chart 4 4: Percutaneous Ventricular Assist Device Market, U.S., 2014 - 2024 85
  • Chart 4 5: Implantable Ventricular Assist Device Market, U.S., 2014 - 2024 87
  • Chart 4 6: External Ventricular Assist Device Market by Segment, U.S., 2014 - 2024 89
  • Chart 4 7: External Ventricular Assist Device Market Breakdown by Segment, U.S., 2017 90
  • Chart 4 8: External Ventricular Assist Device Market Breakdown by Segment, U.S., 2024 90
  • Chart 4 9: Short Term External Ventricular Assist Device Market, U.S., 2014 - 2024 92
  • Chart 4 10: Long Term External Ventricular Assist Device Market, U.S., 2014 - 2024 94
  • Chart 4 11: Implantable Ventricular Assist Device Market Units by Indication, U.S., 2014 - 2024 96
  • Chart 4 12: Leading Competitors, Ventricular Assist Device Market, U.S., 2017 101

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: Ventricular Assist Device Market by Segment, U.S., 2014 - 2024 (US$M) 81
  • Figure 4 2: Percutaneous Ventricular Assist Device Market, U.S., 2014 - 2024 84
  • Figure 4 3: Implantable Ventricular Assist Device Market, U.S., 2014 - 2024 86
  • Figure 4 4: External Ventricular Assist Device Market by Segment, U.S., 2014 - 2024 (US$M) 88
  • Figure 4 5: Short Term External Ventricular Assist Device Market, U.S., 2014 - 2024 91
  • Figure 4 6: Long Term External Ventricular Assist Device Market, U.S., 2014 - 2024 93
  • Figure 4 7: Implantable Ventricular Assist Device Market Units by Indication, U.S., 2014 - 2024 95
  • Figure 4 8: Drivers and Limiters, Ventricular Assist Device Market, U.S., 2017 98
  • Figure 4 9: Leading Competitors, Ventricular Assist Device Market, U.S., 2017 101
  • Figure 6 1: Press Release Summary 106
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