Some studies have suggested that PFO closure can reduce the incidence of migraine headaches. While surgery would be considered too risky a treatment for the vast majority of migraine sufferers, these patients represent a large potential market for a less invasive percutaneous procedure. As a result, a number of clinical trials including the PREMIUM, PRIMA, CLOSURE I, ESCAPE, MIST I and MIST II clinical trials were created to investigate the use of PFO devices in treating patients with severe migraines. There are additional studies that have focused on migraine patients that have experienced stroke in the past and therefore may not be representative of otherwise healthy migraine patients. It is probable that PFOs contribute to certain types of migraines and PFO closure would be a suitable treatment for only a percentage of PFO patients.
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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
PATENT FORAMEN OVALE DEVICE MARKET 78
4.1 INTRODUCTION 78
4.2 MARKET ANALYSIS AND FORECAST 80
4.3 DRIVERS AND LIMITERS 82
4.3.1 Market Drivers 82
4.3.2 Market Limiters 82
4.4 COMPETITIVE MARKET SHARE ANALYSIS 84
4.4.1 Potential Competitors 86
ABBREVIATIONS 87
APPENDIX: COMPANY PRESS RELEASES 90
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: Patent Foramen Ovale Device Market, U.S., 2014 – 2024 81
Chart 4 2: Leading Competitors, Patent Foramen Ovale Device Market, U.S., 2017 85
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.