In the United States (U.S.), cardiovascular disease afflicts more than a quarter of the population, causes more than 5 million hospitalizations, and claims nearly 1 million lives each year; additionally, more than $300 billion in healthcare expenditures are incurred annually.  A major portion of these expenditures is associated with the management of the most prevalent acute and chronic myocardial conditions, such as debilitating drug-refractory angina pectoris, congestive heart failure, ischemic heart disease, and myocardial infarction. 

Products expected to have the most profound impact on coronary artery and myocardial disorders—including facilitated anastomosis systems, and particularly, drug-eluting stents—have only recently been approved by the Food and Drug Administration.  Other emerging products, such as high-density lipoprotein-boosting anti-atherosclerosis biotherapies, are estimated to reach the U.S. market during the next five years.  New myocardial revascularization, repair, and regeneration technologies, such as cell transplantation, gene therapy, phototherapy, angiogenic therapy, and ventricular support and remodeling systems, are hopeful treatments for advanced congestive heart failure patients and “no-option” patients. 

In 2003, sales of facilitated anastomosis systems, endovascular brachytherapy, and recently approved drug-eluting stents, totaled an estimated $1.3 billion.  In the year 2006, promising new anti-atherosclerosis drugs are projected to emerge, potentially matching the success of the current multibillion-dollar lipid-lowering drugs market.  In the year 2008, innovative therapies for myocardial revascularization, repair, and regeneration are expected to generate total sales of more than $6.3 billion. 

This dynamic report from Medtech Insight includes analyses of products and technologies, and presents competitors, current and forecast markets, and opportunities in the U.S. market for myocardial revascularization, repair, and regeneration.  Covered topics include anti-atherosclerosis drugs; anti-restenosis gene therapy; biodegradable stents; cardiovascular phototherapy; cell transplantation; device-based ventricular support and remodeling systems; drug-eluting stents; endovascular brachytherapy; endovascular cryotherapy and sonotherapy; facilitated anastomosis systems; growth-factor based angiogenic gene therapy; myocardial cellular tissue repair and regeneration therapies; stem-cell based angiogenic therapy; and transcatheter coronary bypass.

TABLE OF CONTENTS

EXECUTIVE SUMMARY

i.   Coronary Artery Bypass Graft- and Percutaneous Transluminal Coronary Angioplasty-Enabling Technologies Market

ii.   Emerging Anti-Atherosclerosis Drugs Market

iii.  Emerging Myocardial Revascularization Technologies Market

iv.  Emerging Myocardial Repair and Regeneration Systems Market

1. MYOCARDIAL DISEASES:  CLINICAL AND  STATISTICAL OVERVIEW

1.1 Functional Anatomy of the Heart and Circulatory System

1.2 Coronary and Myocardial Disorders Targeted by Emerging Tissue Revascularization, Repair, and Regeneration Technologies

1.2.1 Atherosclerosis

1.2.2 Ischemic Heart Disease

1.2.3 Angina Pectoris/Acute Coronary Syndrome

1.2.4 Acute Myocardial Infarction

1.2.5 Congestive Heart Failure

2. OVERVIEW OF MYOCARDIAL REVASCULARIZATION, REPAIR, AND REGENERATION PRODUCTS AND TECHNOLOGIES

2.1 Coronary Artery Bypass Graft Surgery

2.1.1 Less-Invasive Techniques

2.1.2 Patient Indications and Outcomes

2.2 Percutaneous Transluminal Coronary Angioplasty and Stenting

2.2.1 Restenosis

2.2.2 Patient Indications and Outcomes

2.3 Coronary Artery Bypass Graft- and Percutaneous Transluminal Coronary Angioplasty-Enabling Technologies

2.3.1 Facilitated Anastomosis Systems

2.3.1.1 Advantages Over Manual Suturing Technique

2.3.2 New Anti-Restenosis Technologies

2.3.2.1 Drug-Eluting Stents

2.3.2.1.1 Anti-Restenosis Drugs

2.3.2.1.2 Drug-Delivery Techniques

2.3.2.1.3 SIRIUS and TAXUS Clinical Trial Results

2.3.2.2 Bare-Metal Stenting with Adjuvant Anti-Restenosis Pharmacotherapy

2.3.2.2.1 Utilization Trends

2.3.2.3 Endovascular Brachytherapy

2.3.2.3.1 Radioisotope Sources

2.3.2.3.2 Brachytherapy Delivery Techniques

2.3.2.4 Emerging Alternative Anti-Restenosis Technologies

2.3.2.4.1 Endovascular Cryotherapy

2.3.2.4.1.1 CryoVascular Systems

2.3.2.4.1.2 CryoCath Technologies

2.3.2.4.2 Endovascular Sonotherapy

2.3.2.4.2.1 OmniSonics Medical Technologies

2.3.2.4.2.2 Vascular Solutions

2.3.2.4.3 Anti-Restenosis Gene Therapy

2.3.2.4.4 Biodegradable Stents

2.4 Emerging Anti-Atherosclerosis Drugs

2.4.1 Low-Density Lipoprotein and High-Density Lipoprotein

2.4.2 High-Density Lipoprotein-Boosting Biotherapies

2.4.3 Anti-Inflammatory Biotherapies

2.5 Emerging Myocardial Revascularization Technologies for the Treatment of Congestive Heart Failure

2.5.1 Cardiovascular Phototherapy

2.5.2 Therapeutic Angiogenesis

2.5.2.1 Growth Factor-Based Therapeutic Angiogenesis

2.5.2.2 Stem Cell-Based Therapeutic Angiogenesis

2.5.3 Transcatheter Coronary Artery Bypass

2.5.3.1 Ventriculocoronary Artery Bypass

2.5.3.1.1 Percardia

2.5.3.2 In Situ Coronary Artery Bypass

2.5.3.2.1 Medtronic

2.5.3.2.2 Clinical Trial Results

2.6 Emerging Myocardial Repair and Regeneration Therapies

2.6.1 Cell Transplant Therapies

2.6.1.1 Cell Graft Sources

2.6.1.1.1 Skeletal Myoblasts

2.6.1.1.2 Autologous Bone Marrow-Derived Stem Cells

2.6.1.2 Cellular Therapy Administration

2.6.1.3 Clinical Trial Results

2.6.2 Myocardial Repair and Regeneration Gene Therapy

2.6.2.1 Gene Therapy—Myocardial Contractile Enhancement and Degenerative Remodeling

2.6.2.1.1 Type 6 Adenylate Cyclase Coding Gene

2.6.2.1.2 Beta-Adrenergic Receptor Kinase Carboxyl Terminus Coding Gene

2.6.2.1.3 SR Ca2+-ATPase and Phospholamban Coding Genes

2.6.2.1.4 Prolyl Hydroxylase Collagen Formation Inhibitor

2.6.2.1.5 Tumor-Necrosis Factor Binding Gene

2.6.2.2 Gene Therapy—Heart Tissue Regeneration

2.6.2.2.1 Myocardin Gene Regulator

2.6.3 Emerging Surgical Techniques for Myocardial Support and Ventricular Remodeling

2.6.3.1 Device-Based Ventricular Support and Remodeling

3. MARKETS FOR MYOCARDIAL REVASCULARIZATION, REPAIR, AND REGENERATION PRODUCTS AND TECHNOLOGIES

3.1 Coronary Artery Bypass Graft and Percutaneous Transluminal Coronary Angioplasty Market Trends

3.2 Coronary Artery Bypass Graft- and Percutaneous Transluminal Coronary Angioplasty-Enabling Technologies Market

3.2.1 Facilitated Anastomosis Systems

3.2.1.1 Competition

3.2.1.1.1 Cardica

3.2.1.1.2 Coalescent Surgical/Medtronic

3.2.1.1.3 Converge Medical

3.2.1.1.4 Kensey Nash

3.2.1.1.5 ONUX Medical/Davol/C.R. Bard

3.2.1.1.6 St. Jude Medical

3.2.1.1.7 United States Surgical/Tyco International

3.2.1.1.8 Ventrica

3.2.1.2 Procedure Volumes Forecast

3.2.1.3 Market Forecast

3.2.1.4 Share by Supplier

3.2.2 Drug-Eluting Stents

3.2.2.1 Competition

3.2.2.1.1 Abbott Vascular Devices/Abbott Laboratories

3.2.2.1.2 Boston Scientific

3.2.2.1.3 Cook Group

3.2.2.1.4 Cordis/Johnson & Johnson

3.2.2.1.5 Guidant

3.2.2.1.6 Medtronic

3.2.2.1.7 Other Competitors

3.2.2.2 Procedure Volumes Forecast

3.2.2.3 Market Forecast

3.2.2.4 Share by Supplier

3.2.3 Endovascular Brachytherapy Systems

3.2.3.1 Competition

3.2.3.1.1 Cordis/Johnson & Johnson

3.2.3.1.2 Guidant

3.2.3.1.3 Novoste

3.2.3.2 Procedure Volumes Forecast

3.2.3.3 Market Forecast

3.2.3.4 Share by Supplier

3.3 Emerging Anti-Atherosclerosis Drugs Market

3.3.1 Competition—High-Density Lipoprotein-Boosting Biotherapy

3.3.1.1 AVANT Immunotherapeutics

3.3.1.2 Eli Lilly

3.3.1.3 Lipid Sciences

3.3.1.4 Pfizer

3.3.1.5 Sanofi-Aventis

3.3.2 Competition—Inflammation-Targeting Biotherapy

3.3.2.1 AtheroGenics

3.3.2.2 deCODE Genetics

3.3.2.3 GlaxoSmithKline

3.3.3 Procedure Volumes Forecast

3.3.4 Market Forecast

3.4 Emerging Myocardial Revascularization Technologies Market

3.4.1 Phototherapy Systems

3.4.1.1 Competition

3.4.1.1.1 Miravant Medical Technologies

3.4.1.1.2 Pharmacyclics

3.4.1.2 Procedure Volumes Forecast

3.4.1.3 Market Forecast

3.4.2 Therapeutic Angiogenesis

3.4.2.1 Competition—Growth Factor-Based Therapeutic Angiogenesis

3.4.2.1.1 Aventis Gencell/Sanofi-Aventis

3.4.2.1.2 Corautus Genetics

3.4.2.1.3 GenVec

3.4.2.1.4 Schering

3.4.2.1.5 Valentis

3.4.2.2 Emerging Stem Cell-Based Therapeutic Angiogenesis

3.4.2.3 Procedure Volumes Forecast

3.4.2.4 Market Forecast

3.5 Emerging Myocardial Repair and Regeneration Systems Market

3.5.1 Cell Transplant Therapies

3.5.1.1 Competition—Autologous Cell Transplant Therapy

3.5.1.1.1 AngioGene

3.5.1.1.2 Bioheart

3.5.1.1.3 Cell Transplants International

3.5.1.1.4 GenVec

3.5.1.1.5 Genzyme Biosurgery/Genzyme

3.5.1.1.6 MacroPore Biosurgery

3.5.1.1.7 Osiris Therapeutics

3.5.1.2 Competition—Human Embryonic Stem Cell Therapies

3.5.1.2.1 Advanced Cell Technology

3.5.1.2.2 Geron

3.5.1.3 Procedure Volumes Forecast

3.5.1.4 Market Forecast

3.5.2 Device-Based Ventricular Support and Remodeling Systems

3.5.2.1 Competition

3.5.2.1.1 Abiomed

3.5.2.1.2 Acorn Cardiovascular

3.5.2.1.3 Myocor

3.5.2.2 Procedure Volumes Forecast

3.5.2.3 Market Forecast

4. COMPANY PROFILES

4.1   Abbott Laboratories

4.2   Acorn Cardiovascular, Inc.

4.3   Bioheart, Inc.

4.4   Boston Scientific Corporation

4.5   Coalescent Surgical, Inc./Medtronic, Inc.

4.6   GenVec, Inc.

4.7   Geron Corporation

4.8   GlaxoSmithKline PLC

4.9   Guidant Corporation

4.10 Johnson & Johnson

4.11 Medtronic, Inc.

4.12 Novoste Corporation

4.13 Osiris Therapeutics, Inc.

4.14 Percardia, Inc.

4.15 Pfizer, Inc.

4.16 Pharmacyclics, Inc.

4.17 Schering AG

4.18 St. Jude Medical, Inc.

4.19 Ventrica, Inc.

APPENDIX:  COMPANY LISTING

LIST OF EXHIBITS

Exhibit ES-1:    Common Myocardial Disorders, Incidence and Prevalence, 2003 and 2008

Exhibit ES-2:    Myocardial Revascularization, Repair, and Regeneration Therapies, Procedure Volumes Forecast, 2003-2008

Exhibit ES-3:    Myocardial Revascularization, Repair, and Regeneration Products, Market Forecast, 2003-2008

Exhibit ES-4:    Coronary Artery Bypass Graft- and Percutaneous Transluminal Coronary Angioplasty-Enabling Products, Procedure Volumes Forecast, 2003-2008

Exhibit ES-5:    Coronary Artery Bypass Graft- and Percutaneous Transluminal Coronary Angioplasty-Enabling Products, Market Forecast, 2003-2008

Exhibit ES-6:    Anti-Atherosclerosis Agents, Procedure Volumes Forecast, 2003-2008

Exhibit ES-7:    Anti-Atherosclerosis Agents, Market Forecast, 2003-2008

Exhibit ES-8:    Myocardial Revascularization Therapies, Procedure Volumes Forecast, 2003-2008

Exhibit ES-9:    Myocardial Revascularization Therapy Products, Market Forecast, 2003-2008

Exhibit ES-10:   Myocardial Repair and Regeneration Therapies, Procedure Volumes Forecast, 2003-2008

Exhibit ES-11:   Myocardial Repair and Regeneration Therapy Products, Market Forecast, 2003-2008

Exhibit 1-1:      2004, Ischemic Heart Disease, Facts and Figures

Exhibit 1-2:      2004, Angina Pectoris, Facts and Figures

Exhibit 1-3:      2004, Acute Myocardial Infarction, Facts and Figures

Exhibit 1-4:      Congestive Heart Failure, Classification System

Exhibit 1-5:      2004, Congestive Heart Failure, Facts and Figures

Exhibit 1-6:      Common Myocardial Disorders, Estimated Incidence and Prevalence, 2003 and 2008

Exhibit 2-1:      Advantages and Disadvantages of Conventional and Minimally Invasive Coronary Artery Bypass Graft Procedures

Exhibit 2-2:      Advantages and Disadvantages of Percutaneous Transluminal Coronary Angioplasty/Stenting

Exhibit 2-3:      Advantages and Disadvantages of Facilitated Anastomosis Systems

Exhibit 2-4:      Selected Characteristics of Anti-Restenosis Agents Used in Coronary Drug-Eluting Stents

Exhibit 2-5:      Advantages and Disadvantages of Nondegradable and Biodegradable Drug Carriers for Drug-Eluting Stents

Exhibit 2-6:      Drug-Eluting Stents, SIRIUS and TAXUS Trial Results, Selected Data

Exhibit 2-7:      Advantages and Disadvantages of Endovascular Brachytherapy for Treatment of In-Stent Restenosis

Exhibit 2-8:      Advantages and Disadvantages of Emerging Alternative Anti-Restenosis Technologies

Exhibit 2-9:      Advantages and Disadvantages of Coronary Phototherapy

Exhibit 2-10:     Advantages and Disadvantages of Growth Factor- and Stem Cell-Based Therapeutic Angiogenesis

Exhibit 2-11:     Advantages and Disadvantages of Emerging Transcatheter Coronary Artery Bypass Techniques

Exhibit 2-12:     Advantages and Disadvantages of Selected Autologous Cell Grafts for Myocardial Repair and Regeneration

Exhibit 2-13:     Selected Clinical Data from Cell-Based Myocardial Repair and Regeneration Therapy Trials

Exhibit 2-14:     Selected Emerging Myocardial Tissue Repair and Regeneration Gene Therapy

Exhibit 2-15:     Advantages and Disadvantages of Emerging Passive Ventricular Support and Remodeling Techniques

Exhibit 3-1:      Myocardial Revascularization, Repair, and Regeneration Therapies, Procedure Volumes Forecast, 2003-2008

Exhibit 3-2:      Myocardial Revascularization, Repair, and Regeneration Products, Market Forecast, 2003-2008

Exhibit 3-3:      Coronary Artery Bypass Graft Surgery and Percutaneous Transluminal Coronary Angioplasty/Stenting, Procedure Volumes Forecast, 2003-2008

Exhibit 3-4:      Coronary Artery Bypass Graft- and Percutaneous Transluminal Coronary Angioplasty-Enabling Products, Procedure Volumes Forecast, 2003-2008

Exhibit 3-5:      Coronary Artery Bypass Graft- and Percutaneous Transluminal Coronary Angioplasty-Enabling Products, Market Forecast, 2003-2008

Exhibit 3-6:      2004, Selected Facilitated Anastomosis Systems

Exhibit 3-7:      Facilitated Anastomosis, Procedure Volumes Forecast, 2003-2008

Exhibit 3-8:      Facilitated Anastomosis Systems, Market Forecast, 2003-2008

Exhibit 3-9:      2003, Facilitated Anastomosis Devices Market, Share by Supplier

Exhibit 3-10:     2004, Selected Drug-Eluting Stent Systems

Exhibit 3-11:     Drug-Eluting and Bare Metal Coronary Stents, Procedure Volumes Forecast, 2003-2008

Exhibit 3-12:     Drug-Eluting Stents and Total Coronary Stents, Market Forecast, 2003-2008

Exhibit 3-13:     2003, Coronary Stents Market, Share by Supplier

Exhibit 3-14:     2004, Selected Coronary Endovascular Brachytherapy Systems

Exhibit 3-15:     Coronary Endovascular Brachytherapy, Procedure Volumes Forecast, 2003-2008

Exhibit 3-16:     Coronary Endovascular Brachytherapy Products, Market Forecast, 2003-2008

Exhibit 3-17:     2003, Coronary Endovascular Brachytherapy Products Market, Share by Supplier

Exhibit 3-18:     2004, Selected Emerging Anti-Atherosclerosis Drugs

Exhibit 3-19:     Anti-Atherosclerosis Agents, Procedure Volumes Forecast, 2003-2008

Exhibit 3-20:     Anti-Atherosclerosis Agents, Market Forecast, 2003-2008

Exhibit 3-21:     Myocardial Revascularization Therapies, Procedure Volumes Forecast, 2003-2008

Exhibit 3-22:     Myocardial Revascularization Therapy Products, Market Forecast, 2003-2008

Exhibit 3-23:     2004, Selected Emerging Coronary Phototherapy Systems

Exhibit 3-24:     Coronary Phototherapy, Procedure Volumes Forecast, 2003-2008

Exhibit 3-25:     Coronary Phototherapy Products, Market Forecast, 2003-2008

Exhibit 3-26:     2004, Selected Emerging Therapeutic Angiogenesis Agents for Myocardial Revascularization

Exhibit 3-27:     Growth Factor-Based Therapeutic Angiogenesis, Procedure Volumes Forecast, 2003-2008

Exhibit 3-28:     Growth Factor-Based Therapeutic Angiogenesis, Market Forecast, 2003-2008

Exhibit 3-29:     Myocardial Repair and Regeneration Therapies, Procedure Volumes Forecast, 2003-2008

Exhibit 3-30:     Myocardial Repair and Regeneration Therapy Products, Market Forecast, 2003-2008

Exhibit 3-31:     2004, Selected Emerging Myocardial Tissue Repair and Regeneration Therapies

Exhibit 3-32:     Autologous Cell Transplant-Based Myocardial Repair and Regeneration Therapies, Procedure Volumes Forecast, 2003-2008

Exhibit 3-33:     Autologous Cell Transplant-Based Myocardial Repair and Regeneration Therapies, Market Forecast, 2003-2008

Exhibit 3-34:     2004, Selected Emerging Passive Ventricular Support and Remodeling Devices

Exhibit 3-35:     Passive Ventricular Support and Remodeling Devices, Procedure Volumes Forecast, 2003-2008

Exhibit 3-36:     Passive Ventricular Support and Remodeling Devices, Market Forecast, 2003-2008

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