US Market Report for Ventricular Assist Devices 2018 - MedCore

  • ID: 4435270
  • Report
  • Region: United States
  • 381 pages
  • iData Research
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FEATURED COMPANIES

  • Abbott Laboratories
  • Boston Scientific
  • Cryolife
  • Karl Storz
  • Microline Surgical
  • SentreHeart
  • MORE
The American Heart Association (AHA) estimates that 5.1 million people suffer from HF in the U.S. and approximately 550,000 new cases are diagnosed each year. Pharmacologic therapies remain the most widely used approach for treatment of HF but heart transplantation remains the only curative option for late stages of the disease. Other procedures to treat HF include angioplasty, biventricular pacing, valve replacement, bypass and left ventricular reduction surgery.

VADs are designed to assist either the left (LVAD), the right (RVAD) ventricle, or both at the same time (BiVAD). The choice of device depends on the underlying heart disease and the pulmonary arterial resistance that determines the load on the right ventricle. LVADs are by far the most commonly performed procedures but when pulmonary resistance is high, right ventricular assist becomes necessary. Biventricular assist devices supply circulatory support to both the right and left ventricle of the heart, by pumping blood to both the systemic and pulmonary systems. Being an assist device, a BiVAD functions in conjunction with the native heart, unlike a total artificial heart with which the native heart is removed.

By retaining the native ventricles of the heart, a BiVAD allows for the possibility of myocardial recovery, which would eliminate the need for cardiac transplantation. For the purpose of this report, VADs are segmented into three categories: percutaneous ventricular assist devices (pVADs), implantable ventricular assist devices and external ventricular assist devices. Implantable VADs are used for bridge-to-recovery (BTR), bridge-to-transplant (BTT) and destination therapy (DT). These labels are described briefly below.
Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • Abbott Laboratories
  • Boston Scientific
  • Cryolife
  • Karl Storz
  • Microline Surgical
  • SentreHeart
  • MORE
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

1. 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

2. 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

3. 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

4. VENTRICULAR ASSIST DEVICE MARKET
4.1 INTRODUCTION
4.2 MARKET OVERVIEW
4.3 MARKET ANALYSIS AND FORECAST
4.3.1 Percutaneous Ventricular Assist Device Market
4.3.2 Implantable Ventricular Assist Device Market
4.3.3 External Ventricular Assist Device Market
4.3.3.1 Short Term External Ventricular Assist Device Market
4.3.3.2 Long Term External Ventricular Assist Device Market
4.4 UNIT ANALYSIS AND FORECAST
4.5 DRIVERS AND LIMITERS
4.5.1 Market Drivers
4.5.2 Market Limiters
4.6 COMPETITIVE MARKET SHARE ANALYSIS
4.6.1 Potential Competitors

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: Ventricular Assist Device Market by Segment, U.S., 2014 – 2024
Chart 4 2: Ventricular Assist Device Market Breakdown by Segment, U.S., 2017
Chart 4 3: Ventricular Assist Device Market Breakdown by Segment, U.S., 2024
Chart 4 4: Percutaneous Ventricular Assist Device Market, U.S., 2014 – 2024
Chart 4 5: Implantable Ventricular Assist Device Market, U.S., 2014 – 2024
Chart 4 6: External Ventricular Assist Device Market by Segment, U.S., 2014 – 2024
Chart 4 7: External Ventricular Assist Device Market Breakdown by Segment, U.S., 2017
Chart 4 8: External Ventricular Assist Device Market Breakdown by Segment, U.S., 2024
Chart 4 9: Short Term External Ventricular Assist Device Market, U.S., 2014 – 2024
Chart 4 10: Long Term External Ventricular Assist Device Market, U.S., 2014 – 2024
Chart 4 11: Implantable Ventricular Assist Device Market Units by Indication, U.S., 2014 – 2024
Chart 4 12: Leading Competitors, Ventricular Assist Device 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: Ventricular Assist Device Market by Segment, U.S., 2014 – 2024 (US$M)
Figure 4 2: Percutaneous Ventricular Assist Device Market, U.S., 2014 – 2024
Figure 4 3: Implantable Ventricular Assist Device Market, U.S., 2014 – 2024
Figure 4 4: External Ventricular Assist Device Market by Segment, U.S., 2014 – 2024 (US$M)
Figure 4 5: Short Term External Ventricular Assist Device Market, U.S., 2014 – 2024
Figure 4 6: Long Term External Ventricular Assist Device Market, U.S., 2014 – 2024
Figure 4 7: Implantable Ventricular Assist Device Market Units by Indication, U.S., 2014 – 2024
Figure 4 8: Drivers and Limiters, Ventricular Assist Device Market, U.S., 2017
Figure 4 9: Leading Competitors, Ventricular Assist Device Market, U.S., 2017
Figure 6 1: Press Release Summary
Note: Product cover images may vary from those shown
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  • 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
  • Berlin Heart
  • Cardica
  • Chase Medical
  • Genesee Biomedical
  • Karl Storz
  • LifeNet Health
  • Microline Surgical
  • Novadaq
  • On-X
  • Saphena Medical
  • SentreHeart
  • Vitalitec
Please Note: Not all companies are currently active in every segment or sub-report from this suite.
Note: Product cover images may vary from those shown
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