EXECUTIVE SUMMARY

i.       Current and Emerging Markets for Selected Myocardial Revascularization Technologies and Products

a.   Facilitated Anastomosis Devices

b.   Drug-Eluting Balloon Angioplasty Systems

c.   Drug-Eluting Stent Systems

d.   Transmyocardial Revascularization Systems

e.   Atherosclerosis Management Biotherapy Products

ii.      Current and Emerging Markets for Selected Myocardial Repair/Regeneration Technologies and Products

a.   Cell-Based Therapies for Myocardial Tissue Repair/Regeneration

b.   Gene-Based Therapies for Myocardial Tissue Repair/Regeneration

c.   Cardiac Structural Support/Modification Products

iii.      Combined Market for Selected Current and Emerging Myocardial Revascularization, Repair, and Regeneration Technologies and Products

iv.     Methodology

 

Exhibit ES-1:    Current and Emerging Myocardial Revascularization Products, Combined Market Forecast, 2007-2011

Exhibit ES-2:    Facilitated Anastomosis Devices Used in Coronary Artery Bypass Graft Surgery, Market Forecast, 2007-2011

Exhibit ES-3:    Drug-Eluting Balloon Angioplasty Systems for Treatment of In-Stent Restenosis, Market Forecast, 2007-2011

Exhibit ES-4:    Coronary Stent Systems, Market Forecast, 2007-2011

Exhibit ES-5:    Transmyocardial Revascularization Products, Market Forecast, 2007-2011

Exhibit ES-6:    Atherosclerosis Management Biotherapy Products, Market Forecast, 2007-2011

Exhibit ES-7:    Current and Emerging Myocardial Repair/Regeneration Products, Combined Market Forecast, 2007-2011

Exhibit ES-8:    Cell-Based Myocardial Tissue Repair/Regeneration Products, Market Forecast, 2007-2011

Exhibit ES-9:    2008, Selected Gene-Based Myocardial Tissue Repair/Regeneration  Approaches under Investigation

Exhibit ES-10:  Cardiac Support/Modification Devices, Market Forecast, 2007-2011

Exhibit ES-11:  Current and Emerging Myocardial Revascularization, Repair, and Regeneration Products, Combined Market Forecast, 2007-2011

 

1. HEART DISEASE/DISORDER OVERVIEW

1.1 Heart Anatomy and Physiology

1.1.1 The Cardiac Conduction System

1.1.2 The Heart Valves

1.2 Selected Heart Diseases/Disorders

1.2.1 Coronary Heart Disease

1.2.1.1 Atherosclerosis

1.2.1.2 Angina Pectoris

1.2.1.3 Myocardial Infarction

1.2.2 Hypertension

1.2.2.1 Systolic and Diastolic Pressures

1.2.2.2 Prehypertension

1.2.3 Cardiac Dysrhythmia

1.2.3.1 Bradycardia

1.2.3.2 Sick Sinus Syndrome

1.2.3.3 Heart Block

1.2.3.4 Atrial Fibrillation

1.2.3.5 Tachycardia

1.2.3.6 Ventricular Fibrillation

1.2.4 Cardiomyopathy

1.2.4.1 Dilated Cardiomyopathy

1.2.4.2 Hypertrophic Cardiomyopathy

1.2.4.3 Restrictive Cardiomyopathy

1.2.5 Heart Valve Disorders

1.2.5.1 Valvular Stenosis

1.2.5.2 Valvular Regurgitation

1.2.5.3 Valve Prolapse

1.2.6 Heart Failure

1.2.6.1 Disease Development

1.2.6.2 Ejection Fraction Reduction

1.2.6.3 Classification/Staging Systems

 

Exhibit 1-1:      Cross-Section Diagram of the Heart

Exhibit 1-2:      Cross-Section Diagram of the Heart Valves

Exhibit 1-3:      Statistics for Selected Heart Disease Risk Factors

Exhibit 1-4:      Standard Angina Pectoris Classification

Exhibit 1-5:      Angina Pectoris, Selected Statistics

Exhibit 1-6:      Myocardial Infarction, Selected Statistics

Exhibit 1-7:      2007, Percentage of Adults Who Have Been Told They Have High Blood Pressure, by State

Exhibit 1-8:      Hypertension, Selected Statistics

Exhibit 1-9:      Cardiac Dysrhythmia, Selected Statistics

Exhibit 1-10:    Cardiomyopathy, Selected Statistics

Exhibit 1-11:    Heart Valve Disorders, Selected Statistics

Exhibit 1-12:    Summary, New York Heart Association Heart Failure Classification System

Exhibit 1-13:    Summary, American College of Cardiology/American Heart Association Heart Failure Staging System

Exhibit 1-14:    Heart Failure, Selected Statistics

 

2. CURRENT AND EMERGIAN MYOCARDIAL REVASCULARIZATION TECHNOLOGIES

2.1 Myocardial Revascularization Technologies

2.1.1 Coronary Artery Bypass Graft Surgery

2.1.1.1 Conventional Coronary Artery Bypass Graft Surgery

2.1.1.2 Less Invasive Coronary Artery Bypass Graft Surgery

2.1.1.2.1 Minimally Invasive Direct Coronary Artery Bypass

2.1.1.2.2 Off-Pump Coronary Artery Bypass

2.1.1.2.3 Port Access Coronary Artery Bypass

2.1.1.2.4 Hybrid Coronary Artery Bypass

2.1.1.2.5 Robotic-Assisted Coronary Artery Bypass

2.1.1.3 Transcatheter Coronary Artery Bypass Techniques

2.1.1.3.1 Ventriculo-Coronary Artery Bypass

2.2.1.3.2 In Situ Coronary Artery Bypass

2.1.1.4 Complications/Efficacy

2.1.1.5 Caseload Volumes Forecast

2.1.2 Facilitated Anastomosis

2.1.2.1 Benefits Compared to Conventional Suturing

2.1.2.2 Technologies

2.1.2.3 Procedure Volumes Forecast

2.1.3 Percutaneous Transluminal Coronary Angioplasty

2.1.3.1 Approaches

2.1.3.2 Applications

2.2.3.3 Complications/Efficacy

2.1.3.4 Caseload Volumes Forecast

2.1.4 Drug-Eluting Balloon Angioplasty

2.1.4.1 Clinical Experience with Drug-Eluting Balloons

2.1.4.1.1 Studies Involving the Paccocath Drug-Eluting Balloon

2.1.4.1.2 Studies Involving the SeQuent Please Drug-Eluting Balloon

2.1.4.2 Regulatory Outlook for Drug-Eluting Balloons

2.1.4.3 Caseload Volumes Forecast

2.1.5 Coronary Stenting

2.1.5.1 Stenting with Bare-Metal and Drug-Eluting Devices

2.1.5.1.1 Stent Materials

2.1.5.1.1.1 Stainless Steel

2.1.5.1.1.2 Nitinol

2.1.5.1.1.3 Tantalum

2.1.5.1.1.4 Cobalt-Chromium Alloys

2.1.5.1.2 Stent Coatings/ Surfaces and Anti-Restenosis Agents

2.1.5.1.2.1 Sirolimus

2.1.5.1.2.2 Paclitaxel

2.1.5.1.2.3 Everolimus

2.1.5.1.2.4 Zotarolimus

2.2.5.1.2.5 Tacrolimus

2.1.5.1.2.6 Biolimus A9

2.1.5.1.2.7 Pimecrolimus

2.1.5.2 Stenting with Bioabsorbable Devices

2.1.5.2.1 The Igaki-Tamai Bioabsorbable Stent

2.1.5.2.2 The Absorbable Metal Stent

2.1.5.2.3 The REVA Bioabsorbable Stent

2.1.5.2.4 The Bioabsorbable Everolimus-Eluting Stent

2.1.5.2.5 Regulatory Outlook

2.1.5.3 Stenting with Biological Material-Carrying Devices

2.1.5.3.1 Endothelial Progenitor Cell Capture Antibodies

2.1.5.3.2 Antisense Agents

2.1.5.4 Stent Delivery

2.1.5.5 Stent Deployment

2.1.5.6 Indications

2.1.5.6.1 Patients with Small Vessel Disease

2.1.5.6.2 Patients with Left Main Disease

2.1.5.7 Complications/Efficacy

2.1.5.7.1 Repeat Revascularization

2.1.5.7.2 Stent Thrombosis

2.1.5.7.3 Diabetes and Stenting

2.1.5.7.4 Stent-Associated ST-Segment Elevation Myocardial Infarction

2.1.5.7.5 Long Lesion Length and Restenosis

2.1.5.8 Caseload Volumes Forecast

2.1.6 Cardiovascular Phototherapy

2.1.7 Therapeutic Angiogenesis

2.1.7.1 Growth Factor-Based Therapy

2.1.2.2 Stem Cell-/Progenitor-Cell Based Therapy

2.1.8 Transmyocardial Revascularization

2.1.8.1 Laser-Based Transmyocardial Revascularization

2.1.8.2 Indications

2.1.8.3 Procedure Volumes Forecast

2.2 Atherosclerosis Management Biotherapies

2.2.1 Pharmacological Approaches to Atherosclerosis Management

2.2.2 Caseload Volumes Forecast

 

Exhibit 2-1:      Advantages and Disadvantages of Conventional and Selected Minimally Invasive Coronary Artery Bypass Techniques

Exhibit 2-2:      Advantages and Disadvantages of Selected Transcatheter Coronary Artery Bypass Techniques

Exhibit 2-3:      Coronary Artery Bypass Graft Surgery, Caseload Volumes Forecast, 2007-2011

Exhibit 2-4:      Facilitated Anastomosis Performed in Conjunction with Coronary Artery Bypass Graft Surgery, Procedure Volumes Forecast, 2007-2011

Exhibit 2-5:      Percutaneous Transluminal Coronary Angioplasty, Caseload Volumes Forecast, 2007-2011

Exhibit 2-6:      Pooled 24-Month Follow-Up Data for PACCOCATH-ISR I/II Trials

Exhibit 2-7:      Six-Month Follow-Up Data for PEPCAD I-SVD Trial

Exhibit 2-8:      Six-Month Follow-Up Data for PEPCAD II-ISR Trial

Exhibit 2-9:      Drug-Eluting Balloon Angioplasty for In-Stent Restenosis, Caseload Volumes Forecast, 2007-2011

Exhibit 2-10:    2008, Selected Anti-Restenosis Agents

Exhibit 2-11:    2008, Selected Data from the PROGRESS-AMS and ABSORB Clinical Trials

Exhibit 2-12:    Coronary Stenting, Caseload Volumes Forecast, 2007-2011

Exhibit 2-13:    Growth Factor- and Stem Cell-Based Therapeutic Angiogenesis

Exhibit 2-14:    Transmyocardial Revascularization, Procedure Volumes Forecast, 2007-2011

Exhibit 2-15:    Atherosclerosis Management Biotherapies, Caseload Volumes Forecast, 2007-2011

 

3. CURRENT AND EMERGING MYOCARDIAL REPAIR/REGENERATION TECHNOLOGIES

3.1 Cell-Based Myocardial Tissue Repair/Regeneration Technologies

3.1.1 Graft Types

3.1.2 Cellular Therapy Administration

3.1.3 Clinical Experience

3.1.4 Procedure Volumes Forecast

3.2 Gene-Based Myocardial Tissue Repair/Regeneration Technologies

3.2.1 Therapeutic Objectives

3.2.2 Therapeutic Approaches

3.3 Cardiac Structural Support and Modification Technologies

3.3.1 Direct Cardiac Compression

3.3.2 Myocardial Support and Remodeling

3.3.3 Surgical Ventricular Restoration

3.3.4 Procedure Volumes Forecast

 

Exhibit 3-1:      Selected Types of Cells under Investigation for Myocardial Tissue Repair/Regeneration

Exhibit 3-2:      Cell-Based Myocardial Tissue Repair/Regeneration, Procedure Volumes Forecast, 2007-2011

Exhibit 3-3:      Cardiac Support/Modification, Procedure Volumes Forecast, 2007-2011

 

4. CURRENT AND EMERGING MARKETS FOR SELECTED MYOCARDIAL REVASCULARIZATION PRODUCTS

4.1 Facilitated Anastomosis Devices

4.1.1 Products

4.1.2 Market Forecast

4.1.3 Competitors

4.2 Drug-Eluting Balloon Angioplasty Systems

4.2.1 Products

4.2.2 Market Forecast

4.2.3 Competitors

4.3 Drug-Eluting Stent Systems

4.3.1 Products

4.3.2 Market Forecast

4.3.3 Competitors

4.4 Transmyocardial Revascularization Systems

4.4.1 Products

4.4.2 Market Forecast

4.4.3 Competitors

4.5 Atherosclerosis Management Biotherapy Products

4.5.1 Products

4.5.1.1 High-Density Lipoprotein-Boosting Biotherapies

4.1.2.2 Inflammatory Process-Targeting Biotherapies

4.5.2 Market Forecast

4.5.3 Competitors

4.6 Combined Myocardial Revascularization Products Market Forecast

 

Exhibit 4-1:      2008, Selected Anastomosis Devices for Cardiac Applications

Exhibit 4-2:      Facilitated Anastomosis Devices Used in Coronary Artery Bypass Graft Surgery, Market Forecast, 2007-2011

Exhibit 4-3:      2007, Market for Facilitated Anastomosis Devices Used in Coronary Artery Bypass Graft Surgery, Share by Supplier

Exhibit 4-4:      Drug-Eluting Balloon Angioplasty Systems for Treatment of In-Stent Restenosis, Market Forecast, 2007-2011

Exhibit 4-5:      2008, Selected Drug-Eluting Coronary Stents

Exhibit 4-6:      Coronary Stent Systems, Market Forecast, 2007-2011

Exhibit 4-7:      2007, Drug-Eluting Coronary Stent Systems, Share by Supplier

Exhibit 4-8:      2008, Selected Transmyocardial Revascularization Products

Exhibit 4-9:      Transmyocardial Revascularization Products, Market Forecast, 2007-2011

Exhibit 4-10:    2007, Transmyocardial Revascularization Products, Share by Supplier

Exhibit 4-11:    2008, Selected Atherosclerosis Management Biotherapies

Exhibit 4-12:    Atherosclerosis Management Biotherapy Products, Market Forecast, 2007-2011

Exhibit 4-13:    Current and Emerging Myocardial Revascularization Products, Combined Market Forecast, 2007-2011

 

5. CURRENT AND EMERGING MARKETS OF SELECTED MYOCARDIAL REPAIR/REGENERATION PRODUCTS

5.1 Cell-Based Therapies for Myocardial Tissue Repair/Regeneration

5.1.1 Cell Types

5.1.1.1 Adipose-Derived Stem Cells

5.1.1.2 Skeletal Myoblasts

5.1.1.3 Human Adult Mesenchymal Stem Cells

5.1.1.4 Human Embryonic Stem Cells

5.1.1.5 Parthenogenetic Stem Cells

5.1.2 Market Forecast

5.1.3 Competitors

5.2 Gene-Based Therapies for Myocardial Tissue Repair/Regeneration

5.2.1 Gene-Based Approaches under Investigation for the Enhancement of Myocardial Tissue Contractile Function and Prevention of Degenerative Ventricular Remodeling

5.2.1.1 AC6 Coding Gene

5.2.1.2 βARKct Coding Gene

5.2.1.3 SERCA2a and Phospholamban Coding Genes

5.2.1.4 S100A1 Coding Gene

5.2.2 Gene-Based Approaches under Investigation for the Regeneration of Myocardial Tissue

5.2.2.1 Myocardin Transcription Factor

5.2.2.2 p38 MAP Kinase

5.2.3 Market Analysis

5.3 Cardiac Structural Support/Modification Products

5.3.1 Direct Cardiac Compression Devices

5.3.2 Myocardial Support and Remodeling Devices

5.3.3 Surgical Ventricular Restoration Devices

5.3.4 Market Forecast

5.3.5 Competitors

5.4 Combined Myocardial Repair/Regeneration Products Market Forecast

 

Exhibit 5-1:      2008, Selected Cell-Based Myocardial Tissue Repair/Regeneration Technologies in Development

Exhibit 5-2:      Cell-Based Myocardial Tissue Repair/Regeneration Products, Market Forecast, 2007-2011

Exhibit 5-3:      2008, Selected Gene-Based Myocardial Tissue Repair/Regeneration Approaches under Investigation

Exhibit 5-4:      2008, Selected Surgical Ventricular Restoration Devices

Exhibit 5-5:      Cardiac Support/Modification Devices, Market Forecast, 2007-2011

Exhibit 5-6:      2007, Cardiac Support/Modification Devices Market, Share by Supplier

Exhibit 5-7:      Current and Emerging Myocardial Repair/Regeneration Products, Combined Market Forecast, 2007-2011

 

6. COMPANY PROFILES

6.1       Abbott Laboratories

6.2       Advanced Cell Technology, Inc.

6.3       Bioheart, Inc.

6.4       BIOTRONIK GmbH & Company KG

6.5       Boston Scientific Corporation

6.6       B. Braun Melsungen AG

6.7       Cardica, Inc.

6.8       Cardiogenesis Corporation

6.9       Chase Medical, Inc.

6.10     Cordis Corporation/Johnson & Johnson

6.11     Cytori Therapeutics, Inc.

6.12     Esperion Therapeutics, Inc.

6.13     Geron Corporation

6.14     GlaxoSmithKline PLC

6.15     Medtronic, Inc.

6.16     Merck & Company, Inc.

6.17     OrbusNeich

6.18     Osiris Therapeutics, Inc.

6.19     PLC Medical Systems, Inc.

6.20     Roche Group

APPENDIX:  COMPANY LISTING