The vast majority of commercially available tissue valves are xenograft valves derived from animals. Usually, the valves are porcine, meaning from a pig, or bovine, meaning from a cow. The porcine heart is most similar to the human heart and therefore represents the best anatomical fit for replacement. The tissue of the pericardial sac is particularly well suited for a valve leaflet due to its extremely durable physical properties. Before implantation, the tissue undergoes multiple chemical treatments to make it suitable for replacement in the human heart. The tissue is sterilized so that the biological markers are removed, thereby eliminating a response from the host's immune system. The primary advantage of tissue over mechanical valves is that tissue valves are much more biocompatible and thus a patient who receives a tissue valve does not require life-long anti-coagulation therapy. However, a disadvantage of tissue valves is that they are not as durable and typically last between 15 and 20 years before requiring replacement. Nevertheless, advances in polymer coatings have made tissue valves more durable than ever before. Furthermore, several aortic tissue valve replacement devices under development that are currently undergoing clinical trials in the U.S. or awaiting FDA approval may be implanted percutaneously.
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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
TISSUE HEART VALVE MARKET 78
4.1 INTRODUCTION 78
4.2 MARKET OVERVIEW 80
4.2.1 Tissue Heart Valve Market by Device Type 81
4.2.2 Tissue Heart Valve Market by Tissue Type 84
4.3 MARKET ANALYSIS AND FORECAST 87
4.3.1 Total Tissue Heart Valve Market 87
4.3.2 Total Tissue Heart Valve Market by Device Type 89
4.3.2.1 Stented Tissue Heart Valve Market 89
4.3.2.2 Stentless Tissue Heart Valve Market 91
4.3.2.3 Sutureless Tissue Heart Valve Market 93
4.3.3 Total Tissue Heart Valve Market by Tissue 94
4.3.3.1 Xenograft Tissue Heart Valve Market 94
4.3.3.2 Allograft Tissue Heart Valve Market 96
4.4 DRIVERS AND LIMITERS 98
4.4.1 Market Drivers 98
4.4.2 Market Limiters 99
4.5 COMPETITIVE MARKET SHARE ANALYSIS 100
ABBREVIATIONS 103
APPENDIX: COMPANY PRESS RELEASES 106
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: Tissue Heart Valve Market by Device Type, U.S., 2014 – 2024 82
Chart 4 2: Tissue Heart Valve Market Breakdown by Device Type, U.S., 2017 83
Chart 4 3: Tissue Heart Valve Market Breakdown by Device Type, U.S., 2024 83
Chart 4 4: Tissue Heart Valve Market by Tissue Type, U.S., 2014 – 2024 85
Chart 4 5: Tissue Heart Valve Market Breakdown by Tissue Type, U.S., 2017 86
Chart 4 6: Tissue Heart Valve Market Breakdown by Tissue Type, U.S., 2024 86
Chart 4 7: Total Tissue Heart Valve Market, U.S., 2014 – 2024 88
Chart 4 8: Stented Tissue Heart Valve Market, U.S., 2014 – 2024 90
Chart 4 9: Stentless Tissue Heart Valve Market, U.S., 2014 – 2024 92
Chart 4 10: Xenograft Tissue Heart Valve Market, U.S., 2014 – 2024 95
Chart 4 11: Allograft Tissue Heart Valve Market, U.S., 2014 – 2024 97
Chart 4 12: Leading Competitors, Tissue Heart Valve Market, U.S., 2017 102
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: Tissue Heart Valve Market by Device Type, U.S., 2014 – 2024 (US$M) 81
Figure 4 2: Tissue Heart Valve Market by Tissue Type, U.S., 2014 – 2024 (US$M) 84
Figure 4 3: Total Tissue Heart Valve Market, U.S., 2014 – 2024 87
Figure 4 4: Stented Tissue Heart Valve Market, U.S., 2014 – 2024 89
Figure 4 5: Stentless Tissue Heart Valve Market, U.S., 2014 – 2024 91
Figure 4 6: Xenograft Tissue Heart Valve Market, U.S., 2014 – 2024 94
Figure 4 7: Allograft Tissue Heart Valve Market, U.S., 2014 – 2024 96
Figure 4 8: Drivers and Limiters, Tissue Heart Valve Market, U.S., 2017 99
Figure 4 9: Leading Competitors, Tissue Heart Valve Market, U.S., 2017 101
Figure 6 1: Press Release Summary 106
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.
