US Market Report for Remote Hemodynamic Monitoring Systems 2018 - MedCore

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

REMOTE HEMODYNAMIC MONITORING SYSTEM MARKET

4.1 INTRODUCTION

4.2 MARKET ANALYSIS AND FORECAST

4.3 DRIVERS AND LIMITERS

4.3.1 Market Drivers

4.3.2 Market Limiters

4.4 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: Remote Hemodynamic Monitoring System Market, U.S., 2014 – 2024

Chart 4 2: Leading Competitors, Remote Hemodynamic Monitoring System 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: Remote Hemodynamic Monitoring System Market, U.S., 2014 – 2024

Figure 4 2: Drivers and Limiters, Remote Hemodynamic Monitoring System Market, U.S., 2017

Figure 4 3: Leading Competitors, Remote Hemodynamic Monitoring System Market, U.S., 2017

Figure 6 1: Press Release Summary

US Market Report for Remote Hemodynamic Monitoring Systems 2018 - MedCore

Remote hemodynamic monitoring devices are implanted into the patient to monitor the blood pressure in the pulmonary artery. The device takes measurements from inside the body and transmits the data to a secure website for clinicians to review. The clinicians are then able to preemptively able to detect heart failure and treat them before symptoms arise.