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TABLE OF CONTENTS AND LIST OF EXHIBITS
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
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Windhover Information, Inc. |