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.
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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
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
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
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
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.
