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

EXTRACORPOREAL MEMBRANE OXYGENATION MACHINE MARKET 78
4.1 INTRODUCTION 78
4.2 MARKET ANALYSIS AND FORECAST 79
4.3 DRIVERS AND LIMITERS 81
4.3.1 Market Drivers 81
4.3.2 Market Limiters 81
4.4 COMPETITIVE MARKET SHARE ANALYSIS 82

ABBREVIATIONS 83

APPENDIX: COMPANY PRESS RELEASES 86

Chart List
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: Extracorporeal Membrane Oxygenation Machine Market, U.S., 2014 – 2024 80

Figure List
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: Extracorporeal Membrane Oxygenation Machine Market, U.S., 2014 – 2024 (US$M) 79
Figure 4 2: Drivers and Limiters, Extracorporeal Membrane Oxygenation Machine Market, U.S., 2017 81
Figure 6 1: Press Release Summary 86

Companies
• The "US Market Report Suite for Cardiac Surgery and Heart Valve Devices 2018 - MedSuite" includes analysis on the following companies currently active in this market:
• Edwards Lifesciences
• St. Jude Medical
• Medtronic
• Maquet
• Abiomed
• HeartWare Inc.
• Sorin Group
• Terumo
• Abbott Laboratories
• Teleflex Medical
• Cardiac Assist
• AtriCure
• W.L. Gore
• SynCardia
• Boston Scientific
• Cryolife

Others include: Berlin Heart, Cardica, Chase Medical, Genesee Biomedical, Karl Storz, LifeNet Health, Microline Surgical, Novadaq, On-X, Saphena Medical, SentreHeart, Vitalitec, etc.
• *Not all companies are currently active in every segment or sub-report from this suite. For more details contact an iData Research Product Advisor.