Revolutionary Trends in Cardiovascular Medicine: Diagnostics, Therapeutics and Devices Diagnostics, Therapeutics and Devices

SUMMARY

REPORT HIGHLIGHTS

• In 2003, the combined worldwide market for cardiac markers, drugelutingstents, portable automated external defibrillators, and cardiacresynchronization therapy was estimated at $4.46 billion.
• These four areas, plus angiogenesis/gene therapy products introducedduring the forecast period, are expected to rise at an average annual growthrate (AAGR) of 29% to nearly $16 billion in 2008.
• The first four product categories represent segments in which dramaticchange is underway. All of these areas will experience double digit growththroughout the forecast period.
• Angiogenesis-stimulating therapies and gene therapies represent the nextrevolution in this area of healthcare, with approval of the first product,an angiogenesis-stimulating agent, possible before the end of 2004.

INTRODUCTION

Cardiovascular disease comprises conditions that affect the properfunctioning of the heart and blood vessels. Among the most prevalent oflife-threatening diseases are sudden cardiac arrest (SCA), acute myocardialinfarction (AMI), congestive heart failure (CHF) and atherosclerosis. Everyyear, an estimated 17 million people worldwide die of cardiovascular disease,particularly AMIs and strokes.

Cardiovascular disease remains the leadingcause of death in developed countries. In the U.S., one person dies every 30seconds from heart disease. This translates to more than 2,600 people a day.Each year in the U.S., deaths from cardiovascular disease representapproximately 42% of all deaths, or some one million deaths. Heart diseaseis theleading cause of death for all Americans age 35 and older.

This BCC reportprovides an in-depth assessment of new product introductions in severalcategories of cardiovascular medicine that are revolutionizing not onlydiagnosis and treatment of certain cardiovascular disorders, but their marketsas well. These products include cardiac markers for the detection of AMI and CHF,drug-eluting stents to prevent restenosis following percutaneous transluminalcoronary angioplasty, automated external defibrillators to treat patientssuffering from sudden cardiac arrest and cardiac resynchronization therapy forthe treatment of CHF.

Also discussed in this report are advances inangiogenesis stimulation to treat angina, coronary artery disease and peripheralvascular disease, as well as gene therapy approaches to several cardiovasculardisorders.

SCOPE OF STUDY

The report contains:

• A comprehensive overview of one category of diagnostics, one category oftherapeutics and three categories of devices that are, or will berevolutionizing the treatment of cardiovascular diseases
• A chapter on each of the five categories: cardiac markers, drug-elutingstents, automated exexternal defibrillators, cardiac resynchronizationtherapy and angiogenesis/gene therapy
• Full descriptions of the technologies involved and how these differ fromexisting and emerging technologies
• Analysis of the technological approaches undertaken by the variouscompetitors and industry and end-user response to these products
• Regulatory issues and legislation affecting use and marketing of products
• Market forecasts for each category of product through 2008, and profilesof selected competitors in each category are included.

METHODOLOGY

The base year for this study is 2003. Market figures are based on revenues atthe manufacturers' level and are projected at 2004-dollar value (i.e., inflationis not computed into the projection figures).

INFORMATION SOURCES

Data toprepare this study was derived from information obtained from interviews withmanagement at companies competing or which have products in development thatwill compete in the five categories covered in the report. In addition,interviews were conducted with physicians and other professionals working incardiovascular treatment centers to gain insight into clinical assessment andusage of and preference for different therapeutics and devices, and withlaboratory personnel to gain insight into usage of diagnostics. Key informationfrom business literature was used to obtain expert opinions on commercialpotential and market sizes from industry professionals.

TABLE OF CONTENTS

INTRODUCTION

• STUDY GOAL AND OBJECTIVES
• REASONS FOR DOING THE STUDY
• CONTRIBUTIONS OF THE STUDY AND FOR WHOM
• SCOPE AND FORMAT
• METHODOLOGY
• INFORMATION SOURCES
• AUTHOR'S CREDENTIALS
• RELATED BCC WORK CREDENTIALS INCLUDING WORK DONE BY OTHER AUTHORS
• BCC ON-LINE SERVICES

• Summary Table:
  THE MARKETS FOR SELECTED CUTTING-EDGE CARDIOVASCULAR THERAPIES: WORLDWIDE,THROUGH 2008 ($ MILLIONS)
• Summary Figure:
  PERCENT OF THE MARKET HELD BY SELECTED CUTTING-EDGE CARDIOVASCULARTHERAPIES: WORLDWIDE, 2003 AND 2008 (%)

• INTRODUCTION
• DISEASE APPLICATIONS OF CARDIAC MARKERS
  • ACUTE CORONARY SYNDROME
    • Angina Pectoris
      • Angina Pectoris (Continued)
    • Myocardial Infarction
  • CONGESTIVE HEART FAILURE
    • Congestive Heart Failure (Continued)
  • CORONARY ARTERY DISEASE
• EXPANDING USE OF CARDIAC MARKERS IN DIAGNOSTICS
• THE RISE IN POINT-OF-CARE DIAGNOSTICS
  • THE MARKET FOR CARDIAC POC TESTING
• Table 1 POINT-OF-CARE CARDIAC TESTING MARKET: WORLDWIDE, THROUGH 2008 ($MILLIONS)
• Table 2 POINT-OF-CARE CARDIAC TESTING MARKET: U.S., THROUGH 2008 ($MILLIONS)
  • DETERMINING WHETHER TO USE POC CARDIAC TESTING IN THE ED
    • Considerations of Turnaround Times
    • The Importance of Quantitative Results
    • Concerns About Standardization
  • LEADERS IN POC CARDIAC MARKET TESTING
  • INCREASING AVAILABILITY OF POINT-OF-CARE TESTING OF CARDIAC MARKERS
  • THE OVERALL POC TESTING MARKET
• Table 3 VENUES FOR POC TESTING
• Table 4 FACTORS INFLUENCING THE EXPANSION OF POC TESTING
• Table 5 TECHNOLOGY ADVANCES INFLUENCING THE EXPANSION OF POC TESTING
• Table 6 THE EFFECT ON POC TESTING ON THE HEALTHCARE BUSINESS ENVIRONMENT
  • THE MARKET FOR POC TESTING
• Table 7 ESTIMATED REVENUES FOR POINT-OF-CARE TESTING AND TOTAL IN VITRODIAGNOSTIC MARKET: WORLDWIDE, THROUGH 2008 ($ MILLIONS)
• Figure 1 ESTIMATED REVENUES FOR POINT-OF-CARE TESTING AND TOTAL IN VITRODIAGNOSTIC MARKET: WORLDWIDE, 2002-2008 ($ MILLIONS)
• Table 8 POINT-OF-CARE TESTING AS PERCENTAGE OF THE IN VITRO DIAGNOSTICMARKET: WORLDWIDE, THROUGH 2008 (%)
• Table 9 GEOGRAPHIC SHARES OF GLOBAL POINT-OF-CARE DIAGNOSTIC TESTINGMARKET: 2002 ($ MILLIONS)
• Figure 2 GEOGRAPHIC SHARES OF GLOBAL POINT-OF-CARE DIAGNOSTIC TESTINGMARKET: 2002 (%)
• Table 10 U.S. POINT-OF-CARE DIAGNOSTIC TESTING MARKET BY LOCATION, 2002 ($MILLIONS)
• Table 11 POINT-OF-CARE DIAGNOSTIC TESTING MARKET: U.S., THROUGH 2008 ($MILLIONS)
• Table 12 EUROPEAN POINT-OF-CARE DIAGNOSTIC TESTING MARKET BY COUNTRY, 2002($ MILLIONS)
  • THE RELATIONSHIP BETWEEN INFLAMMATION AND CARDIAC DISEASE RISK
• Table 13 INFLAMMATION MARKERS ASSOCIATED WITH CARDIOVASCULAR RISK
  • MARKERS USED IN DIAGNOSTIC TESTING
• Table 14 INFLAMMATORY MARKERS FOR POTENTIAL CLINICAL USE IN ASSESSINGCARDIOVASCULAR RISK
  • RECOMMENDATIONS FOR CLINICAL USE OF CARDIAC INFLAMMATORY MARKERS
    • RECOMMENDATIONS FOR CLINICAL ... (CONTINUED)
• Table 15 RECOMMENDATIONS FOR USE OF MARKERS IN CLINICAL PRACTICE
  • USE OF CARDIAC MARKERS IN DIAGNOSIS OF CARDIAC EVENTS
    • A CLINICAL SURVEY OF CARDIAC MARKER USAGE
      • A Clinical Survey of Cardiac Marker Usage (Continued)
  • THE CRITICAL NEED TO RULE IN OR RULE OUT ACUTE MYOCARDIAL INFARCTION
  • CARDIAC MARKERS USED TO RULE OUT AMI
• Table 16 SERUM MARKERS USED TO IDENTIFY MYOCARDIAL INFARCTION
• Table 17 RECOMMENDED SAMPLING FREQUENCIES FOR CARDIAC MARKERS*
  • THE MARKET FOR CARDIAC MARKER TESTING
• Table 18 ESTIMATED MARKET FOR CARDIAC MARKER TESTING BY TYPE: WORLDWIDE,THROUGH 2008 ($ MILLIONS)
• Figure 3 ESTIMATED MARKET FOR CARDIAC MARKER TESTING BY TYPE: WORLDWIDE,2002-2008 ($ MILLIONS)
  • THE EUROPEAN MARKET FOR CARDIAC MARKER TESTING
• Table 19 ESTIMATED MARKET FOR CARDIAC MARKER TESTING: EUROPE, THROUGH 2008($ MILLIONS)
  • THE U.S. MARKET FOR CARDIAC MARKER TESTING
• Table 20 ESTIMATED REVENUES FOR CARDIAC MARKER TESTING: U.S., THROUGH 2008($ MILLIONS)
• Figure 4 ESTIMATED REVENUES FOR CARDIAC MARKER TESTING: U.S., 2002-2008 ($MILLIONS)
  • C-REACTIVE PROTEIN AND HIGH-SENSITIVITY C-REACTIVE PROTEIN
    • THE MARKET FOR HS-CRP MARKER TESTING
• Table 21 ESTIMATED MARKET FOR HS-CRP MARKER TESTING: WORLDWIDE, THROUGH2008 ($ MILLIONS)
• Table 22 ESTIMATED MARKET FOR HS-CRP MARKER TESTING: U.S., THROUGH 2008($MILLIONS)
  • The Market for HS-CRP Marker Testing (Continued)
  • CREATINE KINASE AND CK-MB ISOENZYMES
    • THE MARKET FOR CK-MB MARKER TESTING
• Table 23 ESTIMATED MARKET FOR CK-MB MARKER TESTING: WORLDWIDE, THROUGH2008 ($ MILLIONS)
• Table 24 ESTIMATED MARKET FOR CK-MB MARKER TESTING: U.S., THROUGH 2008($MILLIONS)
  • The Market for CK-MB Marker Testing (Continued)
  • D-DIMER
  • HOMOCYSTEINE
  • ISCHEMIA-MODIFIED ALBUMIN
    • THE MARKET FOR IMA MARKERS
• Table 25 ESTIMATED MARKET FOR IMA MARKER TESTING: WORLDWIDE, THROUGH 2008($ MILLIONS)
• Table 26 ESTIMATED MARKET FOR IMA MARKER TESTING: U.S., THROUGH 2008($MILLIONS)
  • The Market for IMA Markers (Continued)
  • MYOGLOBIN
    • THE MARKET FOR MYOGLOBIN MARKER TESTING
• Table 27 ESTIMATED MARKET FOR MYOGLOBIN MARKER TESTING: WORLDWIDE, THROUGH2008 ($ MILLIONS)
• Table 28 ESTIMATED MARKET FOR MYOGLOBIN MARKER TESTING: U.S., THROUGH 2008($MILLIONS)
  • TROPONINS
    • NUMBER OF TROPONIN TESTS PERFORMED ANNUALLY
• Table 29 MARKET SIZE FOR TROPONIN MARKERS: WORLDWIDE, THROUGH 2008(MILLIONS OF TESTS)
• Table 30 MARKET SIZE FOR TROPONIN MARKERS: U.S., THROUGH 2008 (MILLIONS OFTESTS)
  • THE MARKET FOR TROPONIN MARKER TESTING
• Table 31 ESTIMATED MARKET FOR TROPONIN MARKER TESTING: WORLDWIDE, THROUGH2008 ($ MILLIONS)
• Table 32 ESTIMATED MARKET FOR TROPONIN MARKER TESTING: U.S., THROUGH 2008($MILLIONS)
  • TROPONIN I VERSUS TROPONIN T
  • COMPANIES MARKETING TROPONIN TESTING PRODUCTS
    • Beckman Coulter
    • i-Stat
    • Response Biomedical
    • Syn•X
  • MARKERS FOR OTHER CARDIAC DISEASES
    • B-TYPE NATRIURETIC PEPTIDE AND N-TERMINAL PROHORMONE BRAINNATRIURETIC PROTEIN
      • The Market for BNP and NT-Pro-BNP Marker Testing
• Table 33 ESTIMATED MARKET FOR BNP/NT-PROBNP MARKER TESTING: WORLDWIDE,THROUGH 2008 ($ MILLIONS)
• Table 34 ESTIMATED MARKET FOR BNP/NT-PROBNP MARKER TESTING: U.S., THROUGH2008 ($MILLIONS)
  • The High Diagnostic Accuracy of BNP
    • BNP Levels Predictive of Sudden Death
  • Indications for BNP Testing
  • The Value of NT-proBNP Assays
  • BNP versus NT-proBNP
  • Marketers of BNP Tests and NT-proBNP Tests
    • Axis-Shield/Abbott Laboratories
    • Bayer HealthCare
    • Biosite Diagnostics
    • Dade Behring
    • Roche
    • Syn•X
  • TROPONIN
  • COMBINATION CARDIAC MARKER PANELS
  • REIMBURSEMENT FOR MARKER TESTING
  • CARDIAC MARKERS IN DEVELOPMENT
    • MYELOPEROXIDASE
    • NOURIN-1
    • PLATELET DENSITY
    • WHOLE BLOOD CHOLINE
    • OTHER PRODUCTS
  • NATIONAL ACADEMY OF CLINICAL BIOCHEMISTRY RECOMMENDATIONS FORAVAILABILITY OF CARDIAC MARKER TESTING
  • OTHER INDICATIONS FOR THE USE OF CARDIAC MARKERS
    • PREDICTIVE TESTING OF AMI
    • TREATMENT MONITORING
    • INDICATORS OF SPECIFIC THERAPEUTIC INTERVENTION
  • COMPANY PROFILES
    • ABBOTT LABORATORIES
      • Business Overview
      • Financial Information
      • Cardiac Marker Products
      • Corporate Strategy
    • BIOSITE INC.
      • Business Overview
      • Financial Information
      • Cardiac Marker Products
      • Corporate Strategy
    • I-STAT CORPORATION
      • Business Overview
      • Financial Information
      • Cardiac Marker and Analyzer Products
      • Corporate Strategy
    • SPECTRAL DIAGNOSTICS INC.
      • Business Overview
      • Financial Information
      • Cardiac Marker Products
      • Corporate Strategy
    • SYN•X PHARMA, INC.
      • Business Overview
      • Financial Information
      • Cardiac Marker Products and Proteomics Technology
      • Corporate Strategy
        • Corporate Strategy (Continued)

• THE RAPID REVOLUTION IN PERCUTANOUS TRANSLUMINAL CORONARY ANGIOPLASTYTECHNOLOGY
  • PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY
    • Trends in PTCA
• HISTORY OF STENTS
• PROCEDURE FOR PLACING STENTS
• COSTS OF PTCA, STENTING AND CABG
• Table 35 AVERAGE COSTS OF PTCA, STENTING AND CABG
  • COMPOSITION OF DRUG-ELUTING STENTS
• Table 36 CHARACTERISTICS OF DIFFERENT TYPES OF DRUG-ELUTING STENTS
• Table 36 (CONTINUED)
  • DRUGS USED IN MARKETED AND IN-DEVELOPMENT STENTS
    • ABT-578
    • Dexamethasone
    • Everolimus
    • Paclitaxel
    • Prostaglandin E-1
    • Sirolimus
    • Tacrolimus
  • THE WORLDWIDE MARKET FOR DRUG-ELUTING STENTS
• Table 37 ESTIMATED WORLDWIDE MARKET FOR DRUG-ELUTING STENTS, THROUGH 2008($ MILLIONS)
• Figure 5 DRUG-ELUTING STENT SHARE OF THE WORLDWIDE CORONARY STENT MARKET,2003 AND 2008 (UNITS)
• Figure 6 DRUG-ELUTING STENT SHARE OF THE WORLDWIDE CORONARY STENT MARKET,2003 AND 2008 (DOLLAR VOLUME)
• Figure 6 (CONTINUED)
  • THE U.S. MARKET FOR DRUG-ELUTING STENTS
• Table 38 ESTIMATED U.S. SALES OF CORONARY STENTS, THROUGH 2008 ($MILLIONS)
• Table 38 (CONTINUED)
• Table 39 THE ESTIMATED MARKET FOR DRUG-ELUTING STENTS: U.S., THROUGH 2008($ MILLIONS)
  • THE EUROPEAN MARKET FOR DRUG-ELUTING STENTS
• Table 40 THE ESTIMATED MARKET FOR DRUG-ELUTING STENTS: EUROPE, THROUGH2008 ($ MILLIONS)
  • THE JAPANESE MARKET FOR DRUG-ELUTING STENTS
• Table 41 THE ESTIMATED MARKET FOR DRUG-ELUTING STENTS: JAPAN, THROUGH 2008($ MILLIONS)
  • DRUG-ELUTING STENTS ON THE MARKET
    • CYPHER
    • DEXAMET
    • LIBERTE
    • TAXUS
  • LEADING COMPETITORS IN THE DRUG-ELUTING STENT MARKET
• Table 42 GLOBAL MARKET SHARE FOR DRUG-ELUTING STENTS, BY COMPANY, 2003 (%)
• Figure 7 GLOBAL MARKET SHARE FOR DRUG-ELUTING STENTS, BY COMPANY, 2003 (%)
• Table 43 GLOBAL MARKET SHARE FOR DRUG-ELUTING STENTS, BY COMPANY, 2008 (%)
• Figure 8 GLOBAL MARKET SHARE FOR DRUG-ELUTING STENTS, BY COMPANY, 2008 (%)
• Table 44 U.S. MARKET SHARE FOR DRUG-ELUTING STENTS, BY COMPANY, 2003 (%)
• Table 45 U.S. MARKET SHARE FOR DRUG-ELUTING STENTS, BY COMPANY, 2008 (%)
  • PROFIT MARGINS FOR DRUG-ELUTING STENTS
  • IMPACT OF DRUG-ELUTING STENTS ON THE INTERVENTIONAL CARDIOLOGY MARKET
  • REGULATION OF DRUG-ELUTING STENTS
  • CARDIOLOGISTS' RESPONSE TO THE COST OF DRUG ELUTING STENTS
  • THE HIGH COST OF DRUG-ELUTING STENTS DOES NOT DECREASE PATIENT DEMAND
  • REIMBURSEMENT FOR DRUG-ELUTING STENTS
• Table 46 MEDICARE REIMBURSEMENT MODEL FOR PTCA
  • DRUG-ELUTING STENTS IN DEVELOPMENT
    • ABT-578 DRUG-ELUTING STENT
    • ANGIOGENIX-COATED BIODEGRADABLE/RESORBABLE STENT
    • CHAMPION
    • CHALLENGE AND SPIRIT
    • DEVAX AXXESS BIFURCATION STENT SYSTEM
    • GTU X-STENT, GTU X2-STENT
    • R STENT
    • REVA RESORBABLE STENT
  • COMPANY PROFILES
    • BOSTON SCIENTIFIC CORP.
      • Business Overview
      • Financial Information
      • Leading Cardiac Products
    • CORDIS CORP.
      • Business Overview
      • Drug-Eluting Stents
      • Corporate Strategy
    • ENDOVASC INC.
      • Business Overview
      • Stents and Other Products
      • Corporate Strategy

• HISTORY
• DEFINITION
• WHAT IS A WAVEFORM?
• WHAT IS A DEFIBRILLATOR AND HOW DOES IT WORK?
• THE REQUIREMENT FOR EXACT DOSING
• BIPHASIC VERSUS MONOPHASIC WAVEFORMS
• THE AMERICAN HEART ASSOCIATION ESTABLISHES RECOMMENDATIONS FORALTERNATIVE WAVEFORMS
• DESIGNING THE PERFECT WAVEFORM
  • THE NEED (OR NOT) FOR ESCALATING ENERGY
  • DUAL-MODE AEDS
• APPLICATIONS
  • SUDDEN CARDIAC ARREST
• Table 47 A COMPARISON OF SURVIVAL RATES TO TIME TO DEFIBRILLATION FORSUDDEN CARDIAC ARREST
  • USUAL VENUES FOR SCA
• Table 48 PLACE OF OCCURRENCE OF INCIDENTS OF CARDIAC ARREST
  • SUCCESS OF AEDs
  • TARGETED VENUES FOR AEDs
    • HOSPITALS
    • PUBLIC ACCESS AEDs
      • Studies Show Availability of Public Access AEDs Can Double SCASurvival
      • The City of Los Angeles Municipal AED Placement Program
      • Illinois, Nevada and Other States Enact Legislation RequiringAEDs in High Schools and Other Public Facilities
      • Federal Laws Promoting AED Placement in Public Places
      • Adoption of Public Access AEDs in Other Countries
      • Marketing Strategies for Companies Pursuing the Public AccessArena
      • Availability of AEDs at Walgreen's Online
    • HOME USE AEDs
  • THE MARKET FOR PORTABLE EXTERNAL DEFIBRILLATORS
• Table 49 ESTIMATED WORLDWIDE EXTERNAL DEFIBRILLATOR MARKET (AUTOMATED,MANUAL AND DUAL-MODE PRODUCTS), THROUGH 2008 ($ MILLIONS)
  • U.S. SALES OF EXTERNAL DEFIBRILLATORS BY VENUE
• Table 50 ESTIMATED U.S. MARKET FOR EXTERNAL DEFIBRILLATORS, BY VENUE,THROUGH 2008 ($ MILLIONS)
• Figure 9 ESTIMATED U.S. MARKET FOR EXTERNAL DEFIBRILLATORS, BY VENUE,2002-2008 ($ MILLIONS)
  • THE MARKET FOR AEDs
• Table 51 ESTIMATED AUTOMATED EXTERNAL DEFIBRILLATOR MARKET: WORLDWIDE,THROUGH 2008 ($ MILLIONS)
• Table 52 ESTIMATED U.S. UNIT SALES OF AUTOMATED EXTERNAL DEFIBRILLATORS,THROUGH 2008 (NUMBER OF UNITS)
• Table 53 ESTIMATED AUTOMATED EXTERNAL DEFIBRILLATOR MARKET: U.S., THROUGH2008 ($ MILLIONS)
• Table 54 ESTIMATED MARKET POTENTIAL FOR AEDS AND CURRENT PENETRATION
  • MARKETED AED PRODUCTS
    • AccessAED AND AccessALS
    • AED 10 AND AED 20
    • AED PLUS
      • AED Plus (Continued)
    • FIRSTSAVE AEDs
    • HEARTSTART PRODUCT LINE
    • LIFEPAK CR PLUS, LIFEPAK 12 AND LIFEPAK 500
    • LIFELINE AED
    • MEDTRONIC CR-PLUS
    • POWERHEART AEDs
      • Powerheart AEDs (Continued)
    • SAMARITAN AED
    • A COMPARISON OF MARKETED AEDs
• Table 55 A COMPARISON OF SELECTED AEDs ON THE U.S. MARKET
  • LEADING SUPPLIERS OF AEDs
• Table 56 AMERICAN HEART ASSOCIATION AED CLASSIFICATION SYSTEM
  • COMPETITION
  • MEDICARE REIMBURSEMENT FOR HOME-USE AEDS
  • COMPANY PROFILES
    • ACCESS CARDIOSYSTEMS
      • Business Overview
      • AED Products
    • CARDIAC SCIENCE INC.
      • Business Overview
      • Financial Information
      • AED Products
      • Corporate Strategy
    • DEFIBTECH LLC
      • Business Overview
      • AED Products
      • Corporate Strategy
    • HEARTSINE TECHNOLOGIES, INC.
      • Business Overview
      • Corporate Strategy
    • PHILIPS MEDICAL SYSTEMS
      • Business Overview
      • Financial Information
      • AED Products
      • Corporate Strategy
    • WELCH ALLYN, INC.
      • Business Overview
      • AED Products
      • Corporate Strategy
    • ZOLL MEDICAL CORPORATION
      • Business Overview
      • Financial Information
      • Defibrillator Products
      • Corporate Strategy
        • Corporate Strategy (Continued)

• DEFINITION
• HISTORY
• TECHNOLOGY
  • IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS
  • PACEMAKERS
  • CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
    • Low-Power Devices
    • High-Power Devices
• APPLICATIONS
  • CONGESTIVE HEART FAILURE
    • Congestive Heart Failure (Continued)
    • Treatment
• THE MARKET FOR CARDIAC RESYNCHRONIZATION THERAPY
• Table 57 ESTIMATED WORLDWIDE MARKET FOR CARDIAC RESYNCHRONIZATIONDEFIBRILLATOR DEVICES, THROUGH 2008 ($ MILLIONS)
• Table 58 ESTIMATED U.S. HEART FAILURE MARKET, THROUGH 2008
  • MARKETED CARDIAC RESYNCHRONIZATION THERAPY PRODUCTS
    • CONTAK RENEWAL LINE
    • INSYNC PRODUCT LINE
  • COMPETITORS IN THE CARDIAC RESYNCHRONIZATION THERAPY MARKET
  • REIMBURSEMENT FOR CRT DEVICES
  • CRT DEVICES IN DEVELOPMENT
    • ATLAS+ HF ICD
    • CONTAK RENEWAL 3 AVT
    • INSYNC MAXIMO AND INSYNC SENTRY
  • COMPANY PROFILES
    • GUIDANT CORP.
      • Business Overview
      • Financial Information
      • Leading Cardiac Products
      • Corporate Strategy
    • MEDTRONIC, INC.
      • Business Overview
      • Financial Information
      • Leading Cardiac Products
      • Corporate Strategy
    • ST. JUDE MEDICAL
      • Business Overview
      • Financial Information
      • Leading Cardiac Products
      • Corporate Strategy

• WHAT IS ANGIOGENESIS?
  • DISEASES AFFECTED BY ANGIOGENESIS
• Table 59 CLINICAL TRIALS OF ANGIOGENESIS REGULATING AGENTS BY DISEASE
  • ANGIOGENIC FACTORS
• Table 60 ENDOGENOUS ANGIOGENESIS STIMULATORS
• Table 60 (CONTINUED)
• Table 61 ANGIOGENIC RECEPTORS
  • ANGIOGENESIS STIMULATION FOR THE TREATMENT CARDIOVASCULAR DISEASE
  • ANGIOGENESIS-STIMULATING PRODUCTS AND THERAPIES
    • EPIDERMAL GROWTH FACTORS
    • FIBROBLAST GROWTH FACTORS
      • FGFs in the Treatment of Myocardial Disease
      • FGFs in the Treatment of Peripheral Artery Disease
      • Challenges to Effective FGF Therapy in the Treatment ofCardiovascular Disease
    • NONDRUG THERAPIES TO STIMULATE ANGIOGENESIS
  • THE MARKET FOR ANGIOGENESIS STIMULATING DRUGS
• Table 62 ANGIOGENESIS STIMULATING DRUGS WORLDWIDE SALES, THROUGH 2008 ($MILLIONS)
  • ANGIOGENESIS DRUGS AND THERAPIES IN DEVELOPMENT TO TREATCARDIOVASCULAR DISEASE
    • ANGIOGENIX
      • Angiogenix (Continued)
    • AM132 AND AM133
    • ARTERIOGENESIS
    • BIOBYPASS
    • GENERX
    • IMPACT PRODUCT LINE
    • PERCUTANEOUS MYOCARDIAL REVASCULARIZATION
    • GENE THERAPY
      • Gene Therapy Approaches to Angiogenesis
        • Gene Therapy Approaches to Angiogenesis (Continued)
        • Gene Therapy Approaches to Angiogenesis (Continued)
      • Applications
        • Arterial Restenosis
        • Coronary Artery Disease/Ischemia
          • Coronary Artery Disease/Ischemia (Continued)
        • Peripheral Artery Disease
      • The Market for Gene Therapy
• Table 63 THE MARKET FOR GENE THERAPY: WORLDWIDE, THROUGH 2008 ($ MILLIONS)
  • The U.S. Market for Gene Therapy to Prevent Restenosis
• Table 64 THE MARKET FOR GENE THERAPY TO TREAT RESTENOSIS: U.S., THROUGH2008
  • Products in Development
    • BioByPass
      • BioByPass (Continued)
    • Cyr61
    • Deltavasc
    • GeneRx
    • HIF-1 Alpha
    • Pacemaker Cells
    • Resten-NG
    • VEGF
    • VEGF-2
    • Other Therapies in Development
    • Discontinued Trials and Other Concerns
  • Selected Cardiovascular Gene Therapy Trials
• Table 65 SELECTED CARDIOVASCULAR GENE THERAPY TRIALS
• Table 65 (CONTINUED)
  • The Nagging Question - Will Gene Therapy Ever Become a Reality?
    • The Nagging Question - Will Gene Therapy Ever Become aReality? (Continued)
  • Prospects for Cardiovascular Disease
  • The Vexing Vector Problems
  • Options to Viruses as Vectors
    • Bacteriophage Models
    • Cell-based Gene Transfer
    • Plasmid DNA
      • Surgical Administration of Gene Therapy
      • Catheter-based Myocardial Gene Transfer
    • Liposomes
    • Transcription Factors
  • COMPANY PROFILES
    • AVI BIOPHARM
      • Business Overview
      • Angiogenesis Products
• Table 66 AVI BIOPHARM'S PRODUCT PIPELINE
  • Corporate Strategy
  • CARDIOGENESIS CORP.
    • Business Overview
    • Angiogenesis Technology
    • Corporate Strategy
  • GENVEC INC.
    • Business Overview
    • Gene Therapy Technology and Products
    • Corporate Strategy
  • GENZYME CORP.
    • Business Overview
    • Financial Information
    • Angiogenesis Products
    • Corporate Strategy
  • SCHERING AG
    • Business Overview
    • Financial Information
    • Gene Therapy Products
• Table 67 SCHERING'S GENE THERAPY PRODUCT PIPELINE
  • Corporate Strategy
  • VALENTIS INC.
    • Business Overview
    • Financial Information
    • Gene Therapy Products
• Table 68 VALENTIS' PRODUCT PIPELINE
  • Corporate Strategy

LIST OF TABLES

Summary Table:
THE MARKETS FOR SELECTED CUTTING-EDGE CARDIOVASCULAR THERAPIES: WORLDWIDE,THROUGH 2008 ($ MILLIONS)

Table 1 POINT-OF-CARE CARDIAC TESTING MARKET: WORLDWIDE, THROUGH 2008 ($MILLIONS)

Table 2 POINT-OF-CARE CARDIAC TESTING MARKET: U.S., THROUGH 2008 ($MILLIONS)

Table 3 VENUES FOR POC TESTING

Table 4 FACTORS INFLUENCING THE EXPANSION OF POC TESTING

Table 5 TECHNOLOGY ADVANCES INFLUENCING THE EXPANSION OF POC TESTING

Table 6 THE EFFECT ON POC TESTING ON THE HEALTHCARE BUSINESS ENVIRONMENT

Table 7 ESTIMATED REVENUES FOR POINT-OF-CARE TESTING AND TOTAL IN VITRODIAGNOSTIC MARKET: WORLDWIDE, THROUGH 2008 ($ MILLIONS)

Table 8 POINT-OF-CARE TESTING AS PERCENTAGE OF THE IN VITRO DIAGNOSTICMARKET: WORLDWIDE, THROUGH 2008 (%)

Table 9 GEOGRAPHIC SHARES OF GLOBAL POINT-OF-CARE DIAGNOSTIC TESTINGMARKET: 2002 ($ MILLIONS)

Table 10 U.S. POINT-OF-CARE DIAGNOSTIC TESTING MARKET BY LOCATION, 2002 ($MILLIONS)

Table 11 POINT-OF-CARE DIAGNOSTIC TESTING MARKET: U.S., THROUGH 2008 ($MILLIONS)

Table 12 EUROPEAN POINT-OF-CARE DIAGNOSTIC TESTING MARKET BY COUNTRY, 2002($ MILLIONS)

Table 13 INFLAMMATION MARKERS ASSOCIATED WITH CARDIOVASCULAR RISK

Table 14 INFLAMMATORY MARKERS FOR POTENTIAL CLINICAL USE IN ASSESSINGCARDIOVASCULAR RISK

Table 15 RECOMMENDATIONS FOR USE OF MARKERS IN CLINICAL PRACTICE

Table 16 SERUM MARKERS USED TO IDENTIFY MYOCARDIAL INFARCTION

Table 17 RECOMMENDED SAMPLING FREQUENCIES FOR CARDIAC MARKERS*

Table 18 ESTIMATED MARKET FOR CARDIAC MARKER TESTING BY TYPE: WORLDWIDE,THROUGH 2008 ($ MILLIONS)

Table 19 ESTIMATED MARKET FOR CARDIAC MARKER TESTING: EUROPE, THROUGH 2008($ MILLIONS)

Table 20 ESTIMATED REVENUES FOR CARDIAC MARKER TESTING: U.S., THROUGH 2008($ MILLIONS)

Table 21 ESTIMATED MARKET FOR HS-CRP MARKER TESTING: WORLDWIDE, THROUGH2008 ($ MILLIONS)

Table 22 ESTIMATED MARKET FOR HS-CRP MARKER TESTING: U.S., THROUGH 2008($MILLIONS)

Table 23 ESTIMATED MARKET FOR CK-MB MARKER TESTING: WORLDWIDE, THROUGH2008 ($ MILLIONS)

Table 24 ESTIMATED MARKET FOR CK-MB MARKER TESTING: U.S., THROUGH 2008($MILLIONS)

Table 25 ESTIMATED MARKET FOR IMA MARKER TESTING: WORLDWIDE, THROUGH 2008($ MILLIONS)

Table 26 ESTIMATED MARKET FOR IMA MARKER TESTING: U.S., THROUGH 2008($MILLIONS)

Table 27 ESTIMATED MARKET FOR MYOGLOBIN MARKER TESTING: WORLDWIDE, THROUGH2008 ($ MILLIONS)

Table 28 ESTIMATED MARKET FOR MYOGLOBIN MARKER TESTING: U.S., THROUGH 2008($MILLIONS)

Table 29 MARKET SIZE FOR TROPONIN MARKERS: WORLDWIDE, THROUGH 2008(MILLIONS OF TESTS)

Table 30 MARKET SIZE FOR TROPONIN MARKERS: U.S., THROUGH 2008 (MILLIONS OFTESTS)

Table 31 ESTIMATED MARKET FOR TROPONIN MARKER TESTING: WORLDWIDE, THROUGH2008 ($ MILLIONS)

Table 32 ESTIMATED MARKET FOR TROPONIN MARKER TESTING: U.S., THROUGH 2008($MILLIONS)

Table 33 ESTIMATED MARKET FOR BNP/NT-PROBNP MARKER TESTING: WORLDWIDE,THROUGH 2008 ($ MILLIONS)

Table 34 ESTIMATED MARKET FOR BNP/NT-PROBNP MARKER TESTING: U.S., THROUGH2008 ($MILLIONS)

Table 35 AVERAGE COSTS OF PTCA, STENTING AND CABG

Table 36 CHARACTERISTICS OF DIFFERENT TYPES OF DRUG-ELUTING STENTS

Table 37 ESTIMATED WORLDWIDE MARKET FOR DRUG-ELUTING STENTS, THROUGH 2008($ MILLIONS)

Table 38 ESTIMATED U.S. SALES OF CORONARY STENTS, THROUGH 2008 ($MILLIONS)

Table 39 THE ESTIMATED MARKET FOR DRUG-ELUTING STENTS: U.S., THROUGH 2008($ MILLIONS)

Table 40 THE ESTIMATED MARKET FOR DRUG-ELUTING STENTS: EUROPE, THROUGH2008 ($ MILLIONS)

Table 41 THE ESTIMATED MARKET FOR DRUG-ELUTING STENTS: JAPAN, THROUGH 2008($ MILLIONS)

Table 42 GLOBAL MARKET SHARE FOR DRUG-ELUTING STENTS, BY COMPANY, 2003 (%)

Table 43 GLOBAL MARKET SHARE FOR DRUG-ELUTING STENTS, BY COMPANY, 2008 (%)

Table 44 U.S. MARKET SHARE FOR DRUG-ELUTING STENTS, BY COMPANY, 2003 (%)

Table 45 U.S. MARKET SHARE FOR DRUG-ELUTING STENTS, BY COMPANY, 2008 (%)

Table 46 MEDICARE REIMBURSEMENT MODEL FOR PTCA

Table 47 A COMPARISON OF SURVIVAL RATES TO TIME TO DEFIBRILLATION FORSUDDEN CARDIAC ARREST

Table 48 PLACE OF OCCURRENCE OF INCIDENTS OF CARDIAC ARREST

Table 49 ESTIMATED WORLDWIDE EXTERNAL DEFIBRILLATOR MARKET (AUTOMATED,MANUAL AND DUAL-MODE PRODUCTS), THROUGH 2008 ($ MILLIONS)

Table 50 ESTIMATED U.S. MARKET FOR EXTERNAL DEFIBRILLATORS, BY VENUE,THROUGH 2008 ($ MILLIONS)

Table 51 ESTIMATED AUTOMATED EXTERNAL DEFIBRILLATOR MARKET: WORLDWIDE,THROUGH 2008 ($ MILLIONS)

Table 52 ESTIMATED U.S. UNIT SALES OF AUTOMATED EXTERNAL DEFIBRILLATORS,THROUGH 2008 (NUMBER OF UNITS)

Table 53 ESTIMATED AUTOMATED EXTERNAL DEFIBRILLATOR MARKET: U.S., THROUGH2008 ($ MILLIONS)

Table 54 ESTIMATED MARKET POTENTIAL FOR AEDS AND CURRENT PENETRATION

Table 55 A COMPARISON OF SELECTED AEDs ON THE U.S. MARKET

Table 56 AMERICAN HEART ASSOCIATION AED CLASSIFICATION SYSTEM

Table 57 ESTIMATED WORLDWIDE MARKET FOR CARDIAC RESYNCHRONIZATIONDEFIBRILLATOR DEVICES, THROUGH 2008 ($ MILLIONS)

Table 58 ESTIMATED U.S. HEART FAILURE MARKET, THROUGH 2008

Table 59 CLINICAL TRIALS OF ANGIOGENESIS REGULATING AGENTS BY DISEASE

Table 60 ENDOGENOUS ANGIOGENESIS STIMULATORS

Table 61 ANGIOGENIC RECEPTORS

Table 62 ANGIOGENESIS STIMULATING DRUGS WORLDWIDE SALES, THROUGH 2008 ($MILLIONS)

Table 63 THE MARKET FOR GENE THERAPY: WORLDWIDE, THROUGH 2008 ($ MILLIONS)

Table 64 THE MARKET FOR GENE THERAPY TO TREAT RESTENOSIS: U.S., THROUGH2008

Table 65 SELECTED CARDIOVASCULAR GENE THERAPY TRIALS

Table 66 AVI BIOPHARM'S PRODUCT PIPELINE

Table 67 SCHERING'S GENE THERAPY PRODUCT PIPELINE

Table 68 VALENTIS' PRODUCT PIPELINE  

LIST OF FIGURES

Summary Figure:
PERCENT OF THE MARKET HELD BY SELECTED CUTTING-EDGE CARDIOVASCULARTHERAPIES: WORLDWIDE, 2003 AND 2008 (%)

Figure 1 ESTIMATED REVENUES FOR POINT-OF-CARE TESTING AND TOTAL IN VITRODIAGNOSTIC MARKET: WORLDWIDE, 2002-2008 ($ MILLIONS)

Figure 2 GEOGRAPHIC SHARES OF GLOBAL POINT-OF-CARE DIAGNOSTIC TESTINGMARKET: 2002 (%)

Figure 3 ESTIMATED MARKET FOR CARDIAC MARKER TESTING BY TYPE: WORLDWIDE,2002-2008 ($ MILLIONS)

Figure 4 ESTIMATED REVENUES FOR CARDIAC MARKER TESTING: U.S., 2002-2008 ($MILLIONS)

Figure 5 DRUG-ELUTING STENT SHARE OF THE WORLDWIDE CORONARY STENT MARKET,2003 AND 2008 (UNITS)

Figure 6 DRUG-ELUTING STENT SHARE OF THE WORLDWIDE CORONARY STENT MARKET,2003 AND 2008 (DOLLAR VOLUME)

Figure 7 GLOBAL MARKET SHARE FOR DRUG-ELUTING STENTS, BY COMPANY, 2003 (%)

Figure 8 GLOBAL MARKET SHARE FOR DRUG-ELUTING STENTS, BY COMPANY, 2008 (%)

Figure 9 ESTIMATED U.S. MARKET FOR EXTERNAL DEFIBRILLATORS, BY VENUE,2002-2008 ($ MILLIONS)