VSDs are defects in the ventricular septum, the wall dividing the left and right ventricles of the heart. VSDs are similar to ASDs but tend to cause fewer complications because VSDs are small and most people with the defect barely feel the symptoms. However, approximately 10% of individuals with VSD will develop Eisenmenger’s Syndrome, which is a condition that can curtail life expectancy by several years. This condition can also be found in ASD patients. VSDs are found in approximately 3 to 3.5 of every 1,000 births but the vast majority of VSDs are likely to close spontaneously during childhood. Only in a small percentage of cases, they will have to be treated surgically. ASDs and VSDs can be treated percutaneously by inserting a device through the defect, which expands and forms a seal around the defect. Many of these devices allow heart tissue to grow over the device with time.
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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
ATRIAL AND VENTRICULAR SEPTAL DEFECT DEVICE MARKET 78
4.1 INTRODUCTION 78
4.2 MARKET OVERVIEW 79
4.3 MARKET ANALYSIS AND FORECAST 82
4.3.1 Total Atrial and Ventricular Septal Defect Device Market 82
4.3.2 Atrial Septal Defect Device Market 84
4.3.3 Ventricular Septal Defect Device Market 86
4.4 DRIVERS AND LIMITERS 88
4.4.1 Market Drivers 88
4.4.2 Market Limiters 88
4.5 COMPETITIVE MARKET SHARE ANALYSIS 90
ABBREVIATIONS 92
APPENDIX: COMPANY PRESS RELEASES 95
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: Atrial and Ventricular Septal Defect Device Market by Segment, U.S., 2014 – 2024 80
Chart 4 2: Atrial and Ventricular Septal Defect Device Market Breakdown by Segment, U.S., 2017 81
Chart 4 3: Atrial and Ventricular Septal Defect Device Market Breakdown by Segment, U.S., 2024 81
Chart 4 4: Total Atrial and Ventricular Septal Defect Device Market, U.S., 2014 – 2024 83
Chart 4 5: Atrial Septal Defect Device Market, U.S., 2014 – 2024 85
Chart 4 6: Ventricular Septal Defect Device Market, U.S., 2014 – 2024 87
Chart 4 7: Leading Competitors, Atrial and Ventricular Septal Defect Device Market, U.S., 2017 91
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: Atrial and Ventricular Septal Defect Device Market by Segment, U.S., 2014 – 2024 (US$M) 79
Figure 4 2: Total Atrial and Ventricular Septal Defect Device Market, U.S., 2014 – 2024 82
Figure 4 3: Atrial Septal Defect Device Market, U.S., 2014 – 2024 84
Figure 4 4: Ventricular Septal Defect Device Market, U.S., 2014 – 2024 86
Figure 4 5: Drivers and Limiters, Atrial and Ventricular Septal Defect Device Market, U.S., 2017 89
Figure 4 6: Leading Competitors, Atrial and Ventricular Septal Defect Device Market, U.S., 2017 90
Figure 6 1: Press Release Summary 95
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.
