US Market Report for Mechanical Heart Valves 2018 - MedCore
Mechanical heart valves are prosthetic devices designed to replicate the function of the natural valves of the human heart. Mechanical valves are designed to outlast the patient and some have been stress-tested to last several hundred years. Although mechanical valves are long-lasting and generally only require one surgery for installation, they contribute to an increased risk of blood clot formation. As a result, mechanical valve recipients often take anti-coagulant (blood thinning) drugs such as warfarin for the rest of their lives, which makes the patient more prone to bleeding. Given their durability, mechanical valves are primarily indicated for younger patients and for mitral valve replacement due to its high-pressure gradient. The primary advantage of mechanical over tissue valves is that once a mechanical valve is implanted, they never wear down and rarely need to be replaced. Mechanical valves are made from either pyrolytic carbon or titanium that has been coated with pyrolytic carbon. Pyrolytic carbon is similar to graphite and is used for many biomedical applications. They also can have parts made from Teflon, polyester or polyethylene terephthalate.
- EXECUTIVE SUMMARY
- U.S. CARDIAC SURGERY AND HEART VALVE DEVICE MARKET OVERVIEW
- COMPETITIVE ANALYSIS
- MARKET TRENDS
- MARKET DEVELOPMENTS
- PROCEDURE NUMBERS
- PROCEDURE CODES INVESTIGATED
- MARKETS INCLUDED
- KEY REPORT UPDATES
- VERSION HISTORY
- RESEARCH METHODOLOGY
- Step 1: Project Initiation & Team Selection
- Step 2: Prepare Data Systems and Perform Secondary Research
- Step 3: Preparation for Interviews & Questionnaire Design
- Step 4: Performing Primary Research
- Step 5: Research Analysis: Establishing Baseline Estimates
- Step 6: Market Forecasts and Analysis
- Step 7: Identify Strategic Opportunities
- Step 8: Final Review and Market Release
- Step 9: Customer Feedback and Market Monitoring
- DISEASE OVERVIEW
- 2.1 BASIC ANATOMY
- 2.1.11 Coronary Artery Disease
- 2.1.12 Myocardial Infarction
- 2.1.13 Angina Pectoris
- 2.1.14 Heart Valve Disease
- 2.1.15 Congestive Heart Failure
- PRODUCT PORTFOLIO
- 3.1.1 Tissue Heart Valves
- 3.1.2 Mechanical Tissue Heart Valves
- 3.1.3 Annuloplasty Repair Devices
- 3.1.4 Transcatheter Aortic Valve Replacement Devices
- 3.1.5 Transcatheter Mitral Valve Repair Devices
- 3.1.6 On-Pump Coronary Artery Bypass Devices
- 3.1.7 Off-Pump Coronary Artery Bypass Devices
- 3.1.8 Endoscopic Vessel Harvesting Devices
- 3.1.9 Anastomosis Assist Devices
- 3.1.10 Transmyocardial Revascularization Devices
- 3.1.11 Ventricular Assist Devices
- 3.1.12 Intra-Aortic Balloon Pump Device
- 3.1.13 Temporary Artificial Heart Replacement Device
- 3.1.14 Remote Hemodynamic Monitoring System Devices
- 3.1.15 Patent Foramen Ovale Devices
- 3.1.16 Atrial & Ventricular Septal Defect Device
- 3.1.17 Left Atrial Appendage Closure Device
- 3.1.18 Extracorporeal Membrane Oxygenation Machine
- 3.2 FDA RECALLS
- 3.2.1 MAQUET
- 3.2.2 Medtronic
- 3.2.3 HeartWare Inc
- 3.3 CLINICAL TRIALS
- 3.3.1 Medtronic
- 3.3.2 St. Jude Medical
- 3.3.3 Abiomed
- 3.3.4 Heartware Inc
- MECHANICAL HEART VALVE MARKET
- 4.1 INTRODUCTION
- 4.2 MARKET OVERVIEW
- 4.3 MARKET ANALYSIS AND FORECAST
- 4.3.1 Total Mechanical Heart Valve Market
- 4.3.2 Mechanical Heart Valve without Conduit Market
- 4.3.3 Mechanical Heart Valve with Conduit Market
- 4.4 DRIVERS AND LIMITERS
- 4.4.1 Market Drivers
- 4.4.2 Market Limiters
- 4.5 COMPETITIVE MARKET SHARE ANALYSIS
- ABBREVIATIONS
- APPENDIX: COMPANY PRESS RELEASES
- List of Charts
- Chart 1 1: Cardiac Surgery and Heart Valve Devices Market by Segment, U.S., 2014 – 2024
- Chart 1 2: Cardiac Surgery and Heart Valve Devices Market Overview, U.S., 2017 & 2024
- Chart 4 1: Mechanical Heart Valve Market by Segment, U.S., 2014 – 2024
- Chart 4 2: Mechanical Heart Valve Market Breakdown by Segment, U.S., 2017
- Chart 4 3: Mechanical Heart Valve Market Breakdown by Segment, U.S., 2024
- Chart 4 4: Total Mechanical Heart Valve Market, U.S., 2014 – 2024
- Chart 4 5: Mechanical Heart Valve without Conduit Market, U.S., 2014 – 2024
- Chart 4 6: Mechanical Heart Valve with Conduit Market, U.S., 2014 – 2024
- Chart 4 7: Leading Competitors, Mechanical Heart Valve Market, U.S., 2017
- List of Figures
- Figure 1 1: Cardiac Surgery and Heart Valve Devices Market Share Ranking by Segment, U.S., 2017 (1 of 4)
- Figure 1 2: Cardiac Surgery and Heart Valve Devices Market Share Ranking by Segment, U.S., 2017 (2 of 4)
- Figure 1 3: Cardiac Surgery and Heart Valve Devices Market Share Ranking by Segment, U.S., 2017 (3 of 4)
- Figure 1 4: Cardiac Surgery and Heart Valve Devices Market Share Ranking by Segment, U.S., 2017 (4 of 4)
- Figure 1 5: Companies Researched in this Report, U.S., 2017
- Figure 1 6: Factors Impacting the Cardiac Surgery and Heart Valve Devices Market by Segment, U.S. (1 of 4)
- Figure 1 7: Factors Impacting the Cardiac Surgery and Heart Valve Devices Market by Segment, U.S. (2 of 4)
- Figure 1 8: Factors Impacting the Cardiac Surgery and Heart Valve Devices Market by Segment, U.S. (3 of 4)
- Figure 1 9: Factors Impacting the Cardiac Surgery and Heart Valve Devices Market by Segment, U.S. (4 of 4)
- Figure 1 10: Recent Events in the Cardiac Surgery and Heart Valve Devices Market, U.S., 2015 – 2017
- Figure 1 11: Cardiac Surgery and Heart Valve Devices Procedures Covered, U.S., 2017 (1 of 4)
- Figure 1 12: Cardiac Surgery and Heart Valve Devices Procedures Covered, U.S., 2017 (2 of 4)
- Figure 1 13: Cardiac Surgery and Heart Valve Devices Procedures Covered, U.S., 2017 (3 of 4)
- Figure 1 14: Cardiac Surgery and Heart Valve Devices Procedures Covered, U.S., 2017 (4 of 4)
- Figure 1 15: Procedure Codes Investigated, U.S., 2017
- Figure 1 16: Cardiac Surgery and Heart Valve Devices Markets Covered, U.S., 2017 (1 of 2)
- Figure 1 17: Cardiac Surgery and Heart Valve Devices Markets Covered, U.S., 2017 (2 of 2)
- Figure 1 18: Key Report Updates (1 of 2)
- Figure 1 19: Key Report Updates (2 of 2)
- Figure 1 20: Version History
- Figure 3 1: Tissue Heart Valves by Company
- Figure 3 2: Mechanical Tissue Heart Valves by Company
- Figure 3 3: Annuloplasty Repair Devices by Company
- Figure 3 4: Transcatheter Heart Valve Replacement Devices by Company
- Figure 3 5: Transcatheter Mitral Valve Repair Devices by Company
- Figure 3 6: On-Pump Coronary Artery Bypass Devices by Company
- Figure 3 7: Off-Pump Coronary Artery Bypass Devices by Company
- Figure 3 8: Endoscopic Vessel Harvesting Devices by Company
- Figure 3 9: Anastomosis Assist Devices by Company
- Figure 3 10: Transmyocardial Revascularization Devices by Company
- Figure 3 11: Ventricular Assist Devices by Company
- Figure 3 12: Intra-Aortic Balloon Devices by Company
- Figure 3 13: Temporary Artificial Heart Replacement Devices by Company
- Figure 3 14: Remote Hemodynamic Monitoring System Devices by Company
- Figure 3 15: Patent Foramen Ovale Devices by Company
- Figure 3 16: Atrial & Ventricular Septal Defect Devices by Company
- Figure 3 17: Left Atrial Appendage Closure Devices by Company
- Figure 3 18: Extracorporeal Membrane Oxygenation Machine by Company
- Figure 3 19: Class 2 Device Recall MAQUET
- Figure 3 20: Class 2 Device Recall MAQUET
- Figure 3 21: Class 2 Device Recall MAQUET
- Figure 3 22: Class 1 Device Recall Medtronic
- Figure 3 23: Class 1 Device Recall Heartware Inc
- Figure 3 24: The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
- Figure 3 25: Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance
- Figure 3 26: Medtronic CoreValve Evolut R U.S. Clinical Study
- Figure 3 27: Medtronic Transcatheter Aortic Valve Replacement in Low Risk Patients
- Figure 3 28: AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption
- Figure 3 29: AMPLATZER Duct Occluder II Additional Sizes (ADO II AS)
- Figure 3 30: HeartMate 3 CE Mark Study Long Term Follow-up (HM3 CE LTFU)
- Figure 3 31: Trifecta™ GT Post Market Clinical Follow-up
- Figure 3 32: AMPLATZER™ LAA Occluder Post Approval Study (PAS)
- Figure 3 33: AMPLATZER™ Cardiac Plug Observational Post-Approval Study (ACP PAS China)
- Figure 3 34: MOMENTUM 3 Continued Access Protocol (MOMENTUM 3 CAP)
- Figure 3 35: AMPLATZER™ Amulet™ LAA Occluder Trial (Amulet IDE)
- Figure 3 36: Prevention of Non-Surgical Bleeding by Management of HeartMate II
- Figure 3 37: Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction (DTU)
- Figure 3 38: Protected PCI Study
- Figure 3 39: Assessment of the WATCHMAN™ Device
- Figure 3 40: Watchman FLX Left Atrial Appendage Closure Device Post Approval Study
- Figure 3 41: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
- Figure 4 1: Mechanical Heart Valve Market by Segment, U.S., 2014 – 2024 (US$M)
- Figure 4 2: Total Mechanical Heart Valve Market, U.S., 2014 – 2024
- Figure 4 3: Mechanical Heart Valve without Conduit Market, U.S., 2014 – 2024
- Figure 4 4: Mechanical Heart Valve with Conduit Market, U.S., 2014 – 2024
- Figure 4 5: Drivers and Limiters, Mechanical Heart Valve Market, U.S., 2017
- Figure 4 6: Leading Competitors, Mechanical Heart Valve Market, U.S., 2017
- Figure 6 1: Press Release Summary