US Market Report for On-Pump Coronary Artery Bypass Devices 2018 - MedCore

  • ID: 4435261
  • Report
  • Region: United States
  • 381 pages
  • iData Research
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until Oct 31st 2018
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FEATURED COMPANIES

  • Abbott Laboratories
  • Boston Scientific
  • Cryolife
  • Karl Storz
  • Microline Surgical
  • SentreHeart
  • MORE
CPB is also used in heart valve replacement and repair procedures, repair of septal and congenital heart defects and transplants. However, for the purposes of this report, this chapter analyzes the use of CPB specifically in ONCAB procedures. During an ONCAB procedure, the patient’s heart is stopped temporarily while surgeons use a continuous thread and hand sew vessels together to bypass the blockages. During this procedure, a mechanical cardiopulmonary bypass machine keeps the blood circulating through the body. The blood is rerouted through the healthy vessel and blood flow is restored to the heart muscle. Redirecting the blood flow to a pump enables the surgeon to clamp the aorta and stop the heart, resulting in a motionless and bloodless field. This allows the surgeon to precisely perform manual suturing to obtain accurate connections (anastomoses) between the graft vessel and the aorta, as well as effectively bypass the narrowed or obstructed coronary artery. The absence of blood flow and a motionless heart are important factors in ensuring precision and providing consistent, reproducible positive clinical outcomes.

There are some downsides to the use of CPB pumps. Use of the CPB for circulation exposes the patient’s blood to foreign surfaces, which has been shown to increase the incidence of bleeding and short-term neurocognitive defects. This is known as post-perfusion syndrome or “pump head.” Symptoms of post-perfusion syndrome are subtle and include defects associated with attention, concentration, short-term memory, fine motor function and speed of mental and motor responses. Additionally, stopping of the heart may damage the heart muscle. In certain studies, clamping of the aorta has been shown in certain studies to cause the release of particles into the blood stream that may produce blockages in other parts of the body, such as the brain, which may lead to neurological damage, including strokes. Despite these potential complications, the majority of CABG procedures are still performed on-pump. Furthermore, the percentage of total CABG procedures performed on-pump has been increasing year-over-year since 2004.
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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. ON-PUMP CORONARY ARTERY BYPASS DEVICE MARKET
4.1 INTRODUCTION
4.2 MARKET OVERVIEW
4.3 MARKET ANALYSIS AND FORECAST
4.3.1 On-Pump Coronary Artery Bypass Disposables Market
4.3.2 Perfusion System 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: On-Pump Coronary Artery Bypass Device Market by Segment, U.S., 2014 – 2024
Chart 4 2: On-Pump Coronary Artery Bypass Device Market Breakdown by Segment, U.S., 2017
Chart 4 3: On-Pump Coronary Artery Bypass Device Market Breakdown by Segment, U.S., 2024
Chart 4 4: On-Pump Coronary Artery Bypass Disposables Market, U.S., 2014 – 2024
Chart 4 5: Perfusion System Market, U.S., 2014 – 2024
Chart 4 6: Leading Competitors, On-Pump Coronary Artery Bypass 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: On-Pump Coronary Artery Bypass Device Market by Segment, U.S., 2014 – 2024 (US$M)
Figure 4 2: On-Pump Coronary Artery Bypass Disposables Market, U.S., 2014 – 2024
Figure 4 3: Perfusion System Market, U.S., 2014 – 2024
Figure 4 4: Drivers and Limiters, On-Pump Coronary Artery Bypass Device Market, U.S., 2017
Figure 4 5: Leading Competitors, On-Pump Coronary Artery Bypass Device Market, U.S., 2017
Figure 6 1: Press Release Summary
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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.
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