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Published by: Medtech Insight
Published: Mar. 1, 2007 - 368 Pages
Table of Contents
- EXECUTIVE SUMMARY
- i. Overview of Heart Failure
- a New York Heart Association Classification System
- b. American College of Cardiology/American Heart Association Staging System
- c. Epidemiology of Heart Failure
- ii. Heart Failure-Specific Diagnostic and Therapeutic Products Market
- a. Heart Failure-Specific Device-Based Diagnostic Products Market Segment
- i. B-Type Natriuretic Peptide Testing Products for Heart Failure-Related Applications
- b. Heart Failure-Specific Device-Based Therapeutic Products Market Segment
- i. Cardiac Resynchronization Therapy Devices
- ii. Ventricular Assist Devices
- iii. Intra-Aortic Balloon Pump Producs
- iv. External Counterpulsation Products
- v. Implantable Counterpulsation Systems
- vi. Total Artificial Heart Systems
- vii. Surgical Ventricular Restoration Devices
- c. Heart Failure-Specific Cell- and Gene-Based Therapeutic Products Market Segment
- i. Cell-Based Myocardial Tissue Repair/Regeneration Technologies
- ii. Gene-Based Myocardial Tissue Repair/Regeneration Technologies
- iii. Methodology
- Exhibit ES-1: Summary, American College of Cardiology/American Heart Association Heart Failure Staging System
- Exhibit ES-2: Incidence, Prevalence, and Mortality Figures for Heart Failure and for Selected Cardiac Conditions Contributing to the Onset of Heart Failure
- Exhibit ES-3: Diagnosis and Treatment for Heart Failure, Procedure Volumes Forecast, 2005-2010
- Exhibit ES-4: Heart Failure-Specific Diagnostic and Therapeutic Products, Market Forecast, 2005-2010
- Exhibit ES-5: Heart Failure-Related B-Type Natriuretic Peptide Testing Products, Market Forecast, 2005-2010
- Exhibit ES-6: Heart Failure-Specific Device-Based Therapeutic Products, Market Forecast, 2005-2010
- Exhibit ES-7: Cardiac Resynchronization Therapy Devices, Market Forecast, 2005-2010
- Exhibit ES-8: Ventricular Assist Devices, Market Forecast, 2005-2010
- Exhibit ES-9: Intra-Aortic Balloon Pump Products, Market Forecast, 2005-2010
- Exhibit ES-10: External Counterpulsation Products, Market Forecast, 2005-2010
- Exhibit ES-11: Total Artificial Heart Systems, Market Forecast, 2005-2010
- Exhibit ES-12: Surgical Ventricular Restoration Devices, Market Forecast, 2005-2010
- Exhibit ES-13: Cell Graft Types for Myocardial Tissue Repair/Regeneration Procedures
- Exhibit ES-14: Emerging Cell- and Gene-Based Myocardial Tissue Repair/Regeneration Products, Market Forecast, 2005-2010
- 1. OVERVIEW OF HEART FAILURE
- 1.1 Anatomy and Physiology of the Heart
- 1.2 The Cardiac Conduction System
- 1.3 Heart Failure Etiology and Classification/Staging Systems
- 1.3.1 New York Heart Association Classification System
- 1.3.2 American College of Cardiology/American Heart Association Staging System
- 1.4 Diseases/Disorders Associated with the Development of Heart Failure
- 1.4.1 Cardiac Dysrhythmia
- 1.4.1.1 Bradycardia
- 1.4.1.2 Sick Sinus Syndrome
- 1.4.1.3 Heart Block
- 1.4.1.4 Atrial Fibrillation
- 1.4.1.5 Tachycardia
- 1.4.1.6 Ventricular Fibrillation
- 1.4.2 Cardiomyopathy
- 1.4.2.1 Dilated Cardiomyopathy
- 1.4.2.2 Hypertrophic Cardiomyopathy
- 1.4.2.3 Restrictive Cardiomyopathy
- 1.4.3 Coronary Heart Disease
- 1.4.3.1 Atherosclerosis
- 1.4.3.2 Angina Pectoris
- 1.4.3.3 Myocardial Infarction
- 1.4.4 Hypertension
- 1.4.5 Valvular Disorders
- 1.5 Epidemiology of Heart Failure
- Exhibit 1-1: Cross-Section Diagram of the Normal Heart
- Exhibit 1-2: Summary, New York Heart Association Heart Failure Classification System
- Exhibit 1-3: Summary, American College of Cardiology/American Heart Association Heart Failure Staging System
- Exhibit 1-4: Standard Angina Pectoris Classification
- Exhibit 1-5: Incidence, Prevalence, and Mortality Figures for Heart Failure and for Selected Cardiac Conditions Contributing to the Onset of Heart Failure
- 2. APPROACHES TO THE DIAGNOSIS OF HEART FAILURE
- 2.1 Initial Patient Work-Up
- 2.1.1 Patient History and Physical Examination
- 2.1.2 Electrocardiography
- 2.1.2.1 Resting Electrocardiography
- 2.1.2.2 Holter Monitoring
- 2.1.2.3 Exercise Stress Testing
- 2.2 Diagnostic Imaging
- 2.2.1 X-Ray-Based Imaging
- 2.2.1.1 Conventional X-Ray-Based Imaging
- 2.2.1.2 Angiography
- 2.2.2 Computed Tomography
- 2.2.3 Magnetic Resonance Imaging
- 2.2.4 Nuclear Medicine Imaging
- 2.2.5 Ultrasound Imaging
- 2.3 In Vitro Cardiac Marker Testing
- 2.3.1 Creatine Kinase-MB
- 2.3.2 Myoglobin
- 2.3.3 Troponin-I and Troponin-T
- 2.3.4 Natriuretic Peptides
- 2.3.4.1 B-Type Natriuretic Peptide Testing
- 2.4.4.1.1 Approved Indications for B-Type Natriuretic Peptide Testing
- 2.4.4.1.2 Emerging Heart Failure-Related Applications of B-Type Natriuretic Peptide Testing
- 2.4.4.1.3 B-Type Natriuretic Peptide Testing, Procedure Volumes Forecast
- 2.4.4.1.4 B-Type Natriuretic Peptide Testing Products for Heart Failure-Related Applications
- 2.4.4.1.5 B-Type Natriuretic Peptide Testing Products for Heart Failure-Related Applications, Market Forecast
- 2.4.4.1.6 B-Type Natriuretic Peptide Testing Products for Heart Failure-Related Applications, Competitive Analysis
- Exhibit 2-1: Initial Work-Up for Suspected Heart Failure Patients, Selected Methods of Evaluation
- Exhibit 2-2: Normal Electrocardiogram Tracing
- Exhibit 2-3: Diagnostic Imaging Modalities, Selected Cardiac Applications
- Exhibit 2-4: In Vitro Cardiac Marker Testing, Selected Applications
- Exhibit 2-5: Medical Conditions Associated with Elevated B-Type Natriuretic Peptide Levels
- Exhibit 2-6: B-Type Natriuretic Peptide Cut-Off/Scaling Levels for the Differentiation of Heart Failure and Non-Heart Failure Patients
- Exhibit 2-7: Interpretation of Natriuretic Peptide Levels in Patients Presenting with Acute Dyspnea
- Exhibit 2-8: Correlation of Natriuretic Peptide Levels with New York Heart Association Heart Failure Classes
- Exhibit 2-9: Approved and Emerging Clinical Applications for Heart Failure-Related Natriuretic Peptide Testing
- Exhibit 2-10: Natriuretic Peptide Testing, Procedure Volumes Forecast, 2005-2010
- Exhibit 2-11: Heart Failure-Related B-Type Natriuretic Peptide Testing Products, Market Forecast, 2005-2010
- Exhibit 2-12: 2005, Heart Failure-Related B-Type Natriuretic Peptide Testing Products Market, Share by Supplier
- 3. APPROACHES TO HEART FAILURE MANAGEMENT
- 3.1 Cardiac Resynchronization Therapy
- 3.1.1 Types of Cardiac Resynchronization Therapy Devices
- 3.1.2 Cardiac Resynchronization Therapy, Benefits/Limitations
- 3.1.3 Cardiac Resynchronization Therapy, Indications/Contraindications
- 3.1.4 Cardiac Resynchronization Therapy, Emerging Applications
- 3.1.5 Cardiac Resynchronization Therapy Device Implantation, Procedure Volumes Forecast
- 3.1.6 Cardiac Resynchronization Therapy Devices, Market Analysis
- 3.1.6.1 Products
- 3.1.6.2 Market Forecast
- 3.1.6.3 Competitors
- 3.2 Mechanical Circulatory Support
- 3.2.1 Ventricular Assist Devices
- 3.2.1.1 Types of Ventricular Assist
- 3.2.1.1.1 External Ventricular Assist
- 3.2.1.1.2 Internal Ventricular Assist
- 3.2.1.1.3 Percutaneous Ventricular Assist
- 3.2.1.1.4 Pulsatile Flow Ventricular Assist
- 3.2.1.1.5 Continuous Flow Ventricular Assist
- 3.2.1.2 Ventricular Assist Therapy, Benefits/Limitations
- 3.2.1.3 Ventricular Assist Therapy, Indications/Contraindications
- 3.2.1.4 Ventricular Assist Therapy, Emerging Applications
- 3.2.1.5 Ventricular Assist Device Placement, Procedure Volumes Forecast
- 3.2.1.6 Ventricular Assist Devices, Market Analysis
- 3.2.1.6.1 Products
- 3.2.1.6.2 Market Forecast
- 3.2.1.6.3 Competitors
- 3.2.2 Intra-Aortic Balloon Pump Products
- 3.2.2.1 Intra-Aortic Balloon Pump Therapy, Benefits/Limitations
- 3.2.2.2 Intra-Aortic Balloon Pump Therapy, Indications/Contraindications
- 3.2.2.3 Intra-Aortic Balloon Pump Therapy, Procedure Volumes Forecast
- 3.2.2.4 Intra-Aortic Balloon Pump Products, Market Analysis
- 3.2.2.4.1 Products
- 3.2.2.4.2 Market Forecast
- 3.2.2.4.3 Competitors
- 3.2.3 External Counterpulsation Products
- 3.2.3.1 External Counterpulsation Therapy, Benefits/Limitations
- 3.2.3.2 External Counterpulsation Therapy, Indications/Contraindications
- 3.2.3.3 External Counterpulsation Therapy, Caseload Volumes Forecast
- 3.2.3.4 External Counterpulsation Therapy Systems, Market Analysis
- 3.2.3.4.1 Products
- 3.2.3.4.2 Market Forecast
- 3.2.3.4.3 Competitors
- 3.2.4 Implantable Counterpulsation Systems
- 3.2.4.1 Types of Implantable Counterpulsation Systems
- 3.2.4.1.1 Implantable Intra-Aortic Counterpulsation Systems
- 3.2.4.1.2 Implantable Extra-Aortic Counterpulsation Systems
- 3.2.4.2 Emerging Market for Implantable Counterpulsation Systems
- 3.2.5 Total Artificial Heart Systems
- 3.2.5.1 Complications Associated with Total Artificial Heart System Implantation
- 3.2.5.2 Qualification Criteria for Total Artificial Heart Implantation
- 3.2.5.3 Emerging Market for Total Artificial Heart Implantation
- 3.3 Cardiac Structural Support and Modification Therapies
- 3.3.1 Direct Cardiac Compression Devices
- 3.3.1.1 Products in Development
- 3.3.2 Myocardial Support and Remodeling Devices
- 3.3.2.1 Products in Development
- 3.3.3 Surgical Ventricular Restoration Devices
- 3.3.3.1 Surgical Ventricular Restoration, Procedure Volumes Forecast
- 3.3.3.2 Surgical Ventricular Restoration Devices, Market Analysis
- 3.3.3.2.1 Products
- 3.3.3.2.2 Market Forecast
- 3.3.3.2.3 Competitors
- Exhibit 3-1: Summary, Recommended Heart Failure Treatment Regimens, by Stage
- Exhibit 3-2: Device-Based Heart Failure Therapies, Procedure Volumes Forecast, 2005-2010
- Exhibit 3-3: Heart Failure-Specific Therapeutic Devices, Market Forecast, 2005-2010
- Exhibit 3-4: Cardiac Resynchronization Therapy Device Implantation, Procedure Volumes Forecast, 2005-2010
- Exhibit 3-5: 2007, Selected Cardiac Resynchronization Therapy Devices
- Exhibit 3-6: Cardiac Resynchronization Therapy Devices, Market Forecast, 2005-2010
- Exhibit 3-7: 2006, Cardiac Resynchronization Therapy Devices Market, Share by Supplier
- Exhibit 3-8: Advantages/Disadvantages of Pulsatile and Continuous Flow Ventricular Assist Devices
- Exhibit 3-9: Ventricular Assist Device Placements, Procedure Volumes Forecast, 2005-2010
- Exhibit 3-10: 2007, Selected Ventricular Assist Devices
- Exhibit 3-11: Ventricular Assist Devices, Market Forecast, 2005-2010
- Exhibit 3-12: 2006, Ventricular Assist Devices Market, Share by Supplier
- Exhibit 3-13: Indications/Contraindications for Intra-Aortic Balloon Pump Therapy
- Exhibit 3-14: Intra-Aortic Balloon Pump Therapy, Procedure Volumes Forecast, 2005-2010
- Exhibit 3-15: 2007, Selected Intra-Aortic Balloon Pump Products
- Exhibit 3-16: Intra-Aortic Balloon Pump Products, Market Forecast, 2005-2010
- Exhibit 3-17: 2006, Intra-Aortic Balloon Pump Products Market, Share by Supplier
- Exhibit 3-18: Indications/Contraindications for External Counterpulsation Therapy
- Exhibit 3-19: External Counterpulsation Therapy, Caseload Volumes Forecast, 2005-2010
- Exhibit 3-20: 2007, Selected External Counterpulsation Systems
- Exhibit 3-21: External Counterpulsation Products, Market Forecast, 2005-2010
- Exhibit 3-22: 2006, External Counterpulsation Products Market, Share by Supplier
- Exhibit 3-23: 2007, Selected Implantable Counterpulsation Systems
- Exhibit 3-24: Total Artificial Heart Placement, Procedure Volumes Forecast, 2005-2010
- Exhibit 3-25: 2006, Selected Total Artificial Heart Systems
- Exhibit 3-26: Total Artificial Heart Systems, Market Forecast, 2005-2010
- Exhibit 3-27: Surgical Ventricular Restoration, Procedure Volumes Forecast, 2005-2010
- Exhibit 3-28: 2007, Selected Surgical Ventricular Restoration Devices
- Exhibit 3-29: Surgical Ventricular Restoration Devices, Market Forecast, 2005-2010
- Exhibit 3-30: 2006, Surgical Ventricular Restoration Devices Market, Share by Supplier
- 4. EMERGING CELL- AND GENE-BASED MYOCARDIAL TISSUE REPAIR/REGENERATION TECHNOLOGIES
- 4.1 Cell-Based Myocardial Tissue Repair/Regeneration Technologies
- 4.1.1 Graft Sources
- 4.1.2 Cellular Therapy Administration
- 4.1.3 Clinical Experience with Cell-Based Myocardial Tissue Repair/Regeneration Technologies
- 4.1.4 Cell-Based Myocardial Tissue Repair/Regeneration Technologies in Development
- 4.1.5 Cell-Based Myocardial Tissue Repair/Regeneration, Procedure Volumes Forecast
- 4.2 Gene-Based Myocardial Tissue Repair/Regeneration Technologies
- 4.2.1 Gene-Based Therapies for the Enhancement of Myocardial Tissue Contractile Function and the Prevention of Degenerative Ventricular Remodeling
- 4.2.1.1 Type 6 Adenylate Cyclase Coding Gene
- 4.2.1.2 bARKct Coding Gene
- 4.2.1.3 SERCA2a and Phospholamban Coding Genes
- 4.2.1.4 Prolyl Hydroxylase Collagen Formation Inhibitor
- 4.2.1.5 Tumor Necrosis Factor Binding Gene
- 4.2.2 Gene-Based Therapies for Cardiac Tissue Regeneration
- 4.2.2.1 Adult Cardiomyocyte Division- and Proliferation-Controlling p38 MAP Kinase
- 4.3 Emerging Cell- and Gene-Based Myocardial Tissue Repair/Regeneration Products Market
- Exhibit 4-1: Cell Graft Types for Myocardial Tissue Repair/Regeneration Procedures
- Exhibit 4-2: Selected Clinical Data from Cell-Based Myocardial Tissue Repair/Regeneration Therapy Trials
- Exhibit 4-3: 2007, Selected Cell-Based Myocardial Tissue Repair/Regeneration Technologies in Development
- Exhibit 4-4: Cell-Based Myocardial Tissue Repair/Regeneration, Procedure Volumes Forecast, 2005-2010
- Exhibit 4-5: 2007, Selected Gene-Based Myocardial Tissue Repair/Regeneration Therapies
- Exhibit 4-6: Emerging Cell- and Gene-Based Myocardial Tissue Repair/Regeneration Products, Market Forecast, 2005-2010
- 5. COMPANY PROFILES
- 5.1 Abiomed, Inc
- 5.2 Arrow International, Inc.
- 5.3 Bioheart, Inc.
- 5.4 Biosite, Inc.
- 5.5 BioVentrix, Inc.
- 5.6 Guidant/Boston Scientific Corporation
- 5.7 Chase Medical, Inc.
- 5.8 Datascope Corporation
- 5.9 Geron Corporation
- 5.10 Medtronic, Inc.
- 5.11 Osiris Therapeutics, Inc.
- 5.12 Roche Diagnostics Corporation/F. Hoffmann-La Roche Ltd/Roche Group
- 5.13 St. Jude Medical, Inc.
- 5.14 SynCardia Systems, Inc.
- 5.15 Thoratec Corporation
- 5.16 Vasomedical, Inc.
- 5.17 World Heart Corporation
- APPENDIX: COMPANY LISTING
AbstractMore than 5 million people in the U.S. are now being managed for heart failure, with 550,000 new cases occurring annually. Heart failure is the primary reason for 12 million to 15 million medical visits, 6.5 million to 7.0 million days spent in the hospital each year.
In 2005, heart failure-specific diagnostic and therapeutic modalities were employed in approximately 13.2 million procedures in the U.S., which generated approximately $2.4 billion in corresponding product revenues. The number of heart failure-specific diagnostic and therapeutic procedures performed in the U.S. is projected to expand at a compound annual rate of 6.3%, increasing to an estimated 17.9 million in the year 2010, while combined heart failure-specific diagnostic and treatment product revenues are forecast to grow at a compound annual rate of 16.9%, with revenues increasing to an estimated $5.3 billion in the year 2010.
This dynamic report from Medtech Insight includes analyses of products, current and emerging markets, competitors, and opportunities in the field of device-based heart failure management.
Covered topics in this report include: approaches to the diagnosis and management of heart failure, B-type natriuretic peptide testing products, cardiac resynchronization therapy devices, direct cardiac compression devices, current and emerging cell-based and gene-based myocardial tissue repair/regeneration technologies, external counterpulsation systems, implantable intra-aortic and extra-aortic counterpulsation systems, intra-aortic balloon pump products, myocardial support and remodeling devices, healthcare-related statistics, surgical ventricular restoration systems, total artificial heart systems, and ventricular assist devices.
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