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Market Research Report

US Market Report for Transcatheter Heart Valve Replacement Machines 2018 - MedCore

Published by iData Research Inc. Product code 590192
Published Content info 381 Pages
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US Market Report for Transcatheter Heart Valve Replacement Machines 2018 - MedCore
Published: November 1, 2017 Content info: 381 Pages
Description

The primary method for treating heart valve conditions is through open surgery to place a replacement valve. Biological tissue valves can be allografts (provided by deceased donors), xenografts (bovine or porcine valves) or autografts (using the patient's own pulmonary valve, which in turn, needs to be replaced). Tissue valves have been gaining popularity over the alternative mechanical valves because tissue valves are much more biocompatible and do not require lifelong treatment with

anti-coagulant medication. However, mechanical valves are more durable and are designed to last for

20-30 years, whereas bioprosthetic valves last 10-15 years. Some patients with heart valve problems are poor candidates for valve replacement surgery because they may be too ill to undergo such an invasive procedure. Therefore, there is a great deal of interest in the development of transcatheter heart valve replacement (THVR) devices.

The nomenclature for such devices includes transcatheter heart valve replacement (THVR) and percutaneous heart valve replacement. In this instance, 'percutaneous' is used interchangeably with 'transcatheter'. For the sake of this report, these devices will be referred to as transcatheter heart valve replacement devices. The industry standard is to define these products further by denoting the specific heart valve for which the device is indicated. Examples of this would be transcatheter aortic valve replacement (TAVR), transcatheter mitral valve replacement (TMVR) devices and transcatheter pulmonary valve replacement (TPVR) devices.

In a transcatheter heart valve replacement procedure, a collapsible replacement valve is delivered to the damaged valve via a balloon catheter. The balloon catheter then inflates to expand the replacement within the old valve, pushing the old valve leaflets out of the way and allowing the replacement valve to regulate blood flow. The balloon catheter is then deflated and removed.

Table of Contents
Product Code: iDATA_USCS18_MC_THVR

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

TRANSCATHETER HEART VALVE REPLACEMENT DEVICE MARKET 78

  • 4.1 INTRODUCTION 78
  • 4.2 MARKET ANALYSIS AND FORECAST 80
  • 4.3 DRIVERS AND LIMITERS 83
    • 4.3.1 Market Drivers 83
    • 4.3.2 Market Limiters 84
  • 4.4 COMPETITIVE MARKET SHARE ANALYSIS 86
    • 4.4.1 Potential Competitors 88

ABBREVIATIONS 89

APPENDIX: COMPANY PRESS RELEASES 92

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: Transcatheter Heart Valve Replacement Device Market, U.S., 2014 - 2024 82
  • Chart 4 2: Leading Competitors, Transcatheter Heart Valve Replacement Device Market, U.S., 2017 87

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: Transcatheter Heart Valve Replacement Device Market, U.S., 2014 - 2024 81
  • Figure 4 2: Drivers and Limiters, Transcatheter Heart Valve Replacement Device Market, U.S., 2017 85
  • Figure 4 3: Leading Competitors, Transcatheter Heart Valve Replacement Device Market, U.S., 2017 86
  • Figure 6 1: Press Release Summary 92
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