US Market Report for Left Atrial Appendage Closure Devices 2018 - MedCore

iData Research
394 Pages - IDR10502
$3,495.00

Atrial fibrillation (AF) is an abnormal heart rhythm. Patients with AF experience episodes of rapid and irregular beating. As a result of irregular beating, the atrium in AF patients does not completely contract, impeding the flow of blood from the atria into the ventricles. Blood that is not expelled from the left atria collects in the sac-shaped LAA. Once in the LAA, movement of the blood slows. As blood slows, it tends to clot. Strokes can be caused when blood clots are pumped out of the heart. As a result of increased blood clot formation, AF patients are five to seven times more likely to suffer a stroke than those without AF.
Some patients with AF take a blood thinner, such as warfarin (Coumadin), to reduce the risk of stroke. However, many AF patients dislike taking warfarin due to the increased risk of bleeding, the need to limit vitamin K intake and the increased need for blood draws to measure their international normalized ratio (INR). LAA closure devices were developed as an alternative method of reducing the risk of stroke in AF patients. LAA closure devices are used to seal off the LAA, preventing clot formation in the LAA and eliminating the need for the patient to take blood-thinning medication.

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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
LEFT ATRIAL APPENDAGE CLOSURE DEVICE MARKET 78
4.1 INTRODUCTION 78
4.2 MARKET OVERVIEW 80
4.3 MARKET ANALYSIS AND FORECAST 84
4.3.1 Epicardial Device Market 84
4.3.1.1 Epicardial Clip Device Market 87
4.3.1.1.1 Open Epicardial Clip Device Market 89
4.3.1.1.2 MIS Epicardial Clip Device Market 91
4.3.1.2 Epicardial Suture Device Market 93
4.3.2 Endocardial Device Market 95
4.4 DRIVERS AND LIMITERS 97
4.4.1 Market Drivers 97
4.4.2 Market Limiters 97
4.5 COMPETITIVE MARKET SHARE ANALYSIS 99
4.5.1 Potential Competitors 101
ABBREVIATIONS 102
APPENDIX: COMPANY PRESS RELEASES 105

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: Left Atrial Appendage Closure Device Market by Segment, U.S., 2014 – 2024 82
Chart 4 2: Left Atrial Appendage Closure Device Market Breakdown by Segment, U.S., 2017 83
Chart 4 3: Left Atrial Appendage Closure Device Market Breakdown by Segment, U.S., 2024 83
Chart 4 4: Epicardial Device Market by Segment, U.S., 2014 – 2024 85
Chart 4 5: Epicardial Device Market Breakdown by Segment, U.S., 2017 86
Chart 4 6: Epicardial Device Market Breakdown by Segment, U.S., 2024 86
Chart 4 7: Epicardial Clip Device Market, U.S., 2014 – 2024 88
Chart 4 8: Open Epicardial Clip Device Market, U.S., 2014 – 2024 90
Chart 4 9: MIS Epicardial Clip Device Market, U.S., 2014 – 2024 92
Chart 4 10: Epicardial Suture Device Market, U.S., 2014 – 2024 94
Chart 4 11: Endocardial Device Market, U.S., 2014 – 2024 96
Chart 4 12: Leading Competitors, Left Atrial Appendage Closure Device Market, U.S., 2017 100

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: Left Atrial Appendage Closure Device Market by Segment, U.S., 2014 – 2024 (US$M) 81
Figure 4 2: Epicardial Device Market by Segment, U.S., 2014 – 2024 (US$M) 84
Figure 4 3: Epicardial Clip Device Market, U.S., 2014 – 2024 87
Figure 4 4: Open Epicardial Clip Device Market, U.S., 2014 – 2024 89
Figure 4 5: MIS Epicardial Clip Device Market, U.S., 2014 – 2024 91
Figure 4 6: Epicardial Suture Device Market, U.S., 2014 – 2024 93
Figure 4 7: Endocardial Device Market, U.S., 2014 – 2024 95
Figure 4 8: Drivers and Limiters, Left Atrial Appendage Closure Device Market, U.S., 2017 98
Figure 4 9: Leading Competitors, Left Atrial Appendage Closure Device Market, U.S., 2017 99
Figure 6 1: Press Release Summary 105

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.

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