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US Market Report for Mechanical Heart Valves 2018 - MedCore

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

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