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U.S. Opportunities in Heart Failure Technologies

Published January 2004 | 560 Pages | 168 Exhibits | Forecasts Through 2008


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Companies Covered

Abiomed, Inc


Arrow International, Inc

Bioheart, Inc

BioSite, Inc. 

Collateral Therapeutics, Inc. 

Datascope Corporation

GenVec, Inc. (Diacrin, Inc.)

Guidant Corporation 

Impulse Dynamics NV

Medtronic, Inc

Osiris Therapeutics, Inc. 

St. Jude Medical, Inc

Thoratec Corporation 

Vasomedical, Inc

WorldHeart Corporation

Table of Contents


Overview of Heart Failure 

Diagnostic Testing 

Rhythm Management Technologies 

Ventricular Assist Devices

Other Mechanical Circulatory Support Technologies 

Surgical and Other Approaches 

Cell and Gene Therapy 



Summary Exhibit 1: U.S. Market for Device-Based Heart Failure Technologies, 2002-2008

Summary Exhibit 2: U.S. Heart Failure Patient Forecast by Total Prevalence and NYHA Functional Classification, 2002-2008

Summary Exhibit 3: Penetration of Device-Based Therapies in the U.S. Heart Failure Population, 2002-2008

Summary Exhibit 4: U.S. Market for BNP Testing, 2002-2008 

Summary Exhibit 5: U.S. Market for Rhythm Management Devices in Heart Failure, 2002-2008 

Summary Exhibit 6: U.S. Market for Ventricular Assist Devices, 2002-2008 

Summary Exhibit 7: U.S. Market for Mechanical Circulatory Support Technologies, 2002-2008

Summary Exhibit 8: U.S. Market for Surgical and Other Heart Failure Devices, 2002-2008

Summary Exhibit 9: U.S. Heart Failure Device Market, Supplier Shares, 2003 



1.1 The Heart As A Pump

1.2 Definition of Heart Failure

1.3 Types of Heart Failure 

1.4 Pathophysiology of Heart Failure 

1.5 Clinical Manifestations of Heart Failure

1.6 Classification of Heart Failure 

1.7 Epidemiology of Heart Failure 

1.7.1 Etiology Coronary Artery Disease Hypertension Cardiomyopathy Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Restrictive (Infiltrative) Cardiomyopathy Valvular Heart Disease Other Causes of Heart Failure

1.7.2 Risk Factors 

1.7.3 Incidence & Prevalence 

1.7.4 Mortality 

1.7.5 Morbidity and Economic Impact 

1.8 Diagnosis of Heart Failure 

1.8.1 Scoring Systems

1.8.2 BNP Testing in Heart Failure Economics of BNP testing Suppliers Market Analysis 

1.9 Treatment of Heart Failure

1.10 Diastolic Heart Failure


Exhibit 1-1: The Heart as a Pump

Exhibit 1-2: Types of Heart Failure 

Exhibit 1-3: Effects of neurohormonal agents on cardiac remodeling 

Exhibit 1-4: Compensatory Mechanisms in Heart Failure

Exhibit 1-5: Adverse Effects of Compensatory Mechanisms in Heart Failure

Exhibit 1-6: Evolution of Our Understanding of Heart Failure and the Availability of Various Therapies

Exhibit 1-7: Common Symptoms of Heart Failure 

Exhibit 1-8: NYHA Functional Classification of Heart Failure 

Exhibit 1-9: ACC/AHA Classification of Heart Failure 

Exhibit 1-10: Major Epidemiological Studies for Heart Failure in the U.S.

Exhibit 1-11: Etiology of Heart Failure 

Exhibit 1-12: Risk factors and their relative risks for the development of HF 

Exhibit 1-13: Summary of Results of Major Epidemiological Studies

Exhibit 1-14: Summary of U.S. Heart Failure Epidemiology

Exhibit 1-15: U.S. Heart Failure Patient Forecast by Total Prevalence and NYHA Functional Classification, 2002-2008

Exhibit 1-16: Survival After Heart Failure in the Framingham Heart Study

Exhibit 1-17: Historical Trends in U.S. Hospital Discharges for Heart Failure 

Exhibit 1-18: Estimated Direct and Indirect Costs of Heart Failure

Exhibit 1-19: Sensitivity, Specificity, and Predictive Value of Symptoms, Signs and Chest X-Ray Findings for the Presence of Heart Failure

Exhibit 1-20: Scoring Systems for Heart Failure Diagnosis

Exhibit 1-21: Selected BNP Assays Available in the U.S., 2004 

Exhibit 1-22: Non-Therapeutic/Diagnostic BNP Market, Supplier Shares, 2003 

Exhibit 1-23: U.S. Patient and Market Forecast for BNP Tests, 2002-2008 

Exhibit 1-24: Segmentation of the POC BNP Market, 2002-2008

Exhibit 1-25: Treatment Approaches and Their Impact on Pathophysiology of Heart Failure 

Exhibit 1-26: ACC/AHA Guidelines for Heart Failure Treatment

Exhibit 1-27: Prevalence of Heart Failure with Preserved Systolic Function (Diastolic Heart Failure) 

Exhibit 1-28: Correlation between age and gender in HFPSF/DHF

Exhibit 1-29: Mortality in Diastolic Heart Failure

Exhibit 1-30: Morbidity in Diastolic Heart Failure

Exhibit 1-31: Selected Ongoing Clinical Studies of Diastolic Heart Failure, 2004



2.1 Cardiac Electrophysiology

2.1.1 Measuring the Heart’s Electrical Activity 

2.1.2 Pathophysiology of Abnormal Electrical Timing

2.2 Cardiac Resynchronization Therapy (CRT) 

2.2.1 Technique

2.2.2 Clinical Experience

2.2.3 Defibrillation in Heart Failure Patients

2.2.4 Indications/Contraindications 

2.2.5 Limitations of CRT

2.2.6 Unanswered Issues with CRT

2.2.7 Products and Suppliers Medtronic CRTP CRT-D Leads and Delivery Systems CareLink Network Guidant CRT-D CRTP Leads and Delivery Systems St. Jude Medical CRTP Leads and Delivery Systems CRT-D Biotronik ELA Medical

2.2.8 Potential Patient Population

2.2.9 Procedure Forecast

2.2.10 Market Analysis 

2.3 Other Rhythm Management Approaches to Heart Failure 

2.3.1 Stand Alone ICD Use SCD-HeFT Market Impact

2.3.2 Cardiac Contractility Modulation (Impulse Dynamics)


Exhibit 2-1: Overview of Rhythm Management Approaches to Heart Failure 

Exhibit 2-2: Electric Conduction System of the Heart

Exhibit 2-3: Lead Positions for Biventricular Pacing 

Exhibit 2-4: Early Observational Trials of Biventricular Pacing in Heart Failure 

Exhibit 2-5: Major Biventricular Pacing Trials 

Exhibit 2-6: Major Biventricular Pacing With ICD Trials

Exhibit 2-7: Effect of CRT on Various Heart Parameters 

Exhibit 2-8: Effect of BVP/CRT on Mortality and Morbidity

Exhibit 2-9: Selected CRT Products and Suppliers, 2004 

Exhibit 2-10: Medtronic's CRT Products 

Exhibit 2-11: Guidant's CRT Products 

Exhibit 2-12: St. Jude Medical's CRT Products 

Exhibit 2-13: Biotronik's CRT Products

Exhibit 2-14: Potential U.S. Patient Population for Cardiac Resynchronization Therapy, 2002-2008

Exhibit 2-15: U.S. Procedure and Market Forecast for Cardiac Resynchronization Therapy, 2002-2008

Exhibit 2-16: CRT Market Shares, 2003

Exhibit 2-17: SCDHeFT Results - Hazard Ratios & All Cause Mortality 

Exhibit 2-18: SCD HeFT Results - Subgroup Analyses 

Exhibit 2-19: Potential Patient Population for Stand Alone ICD Therapy in Heart Failure, 2002-2008 

Exhibit 2-20: Procedure and Market Forecast for Stand Alone ICD Therapy in Heart Failure, 2002-2008 

Exhibit 2-21: Impulse Dynamic's Optimizer System 



3.1 VAD Types 

3.1.1 Implantation External VADs Internal VADs Percutaneous VADs

3.1.2 Pump Type Pulsatile Flow Continuous Flow Axial Centrifugal 

3.1.3 Device Selection 

3.2 VAD Indications 

3.2.1 Bridge to Recovery 

3.2.2 Bridge To Transplant 

3.2.3 Destination Therapy

3.2.4 Therapeutic Recovery 

3.3 VAD Contraindications 

3.4 Clinical Experience

3.4.1 Patient Selection

3.4.2 Specific Complications 


3.5 Products and Suppliers

3.5.1 Abiomed

3.5.2 A-Med Systems

3.5.3 Arrow International LionHeart LVAS CorAide

3.5.4 Berlin Heart EXCOR INCOR

3.5.5 Biomedlab Company 

3.5.6 CardiacAssist AB-180 iVAD TandemHeart PTVA

3.5.7 Cardianove

3.5.8 Gold Medical Technologies

3.5.9 Impella CardioSystems impella recover impella acute impella mobile console 

3.5.10 Intra-Vasc

3.5.11 Jarvik Heart

3.5.12 Levitronix

3.5.13 MedQuest Products

3.5.14 MicroMed Technology Device Description Regulatory Status Clinical Experience Chrysalis 

3.5.15 MiTi Heart 

3.5.16 Terumo Heart 

3.5.17 Thoratec Thoratec VAD TLC-II Thoratec IVAD HeartMate LVAS HeartMate IP HeartMate VE HeartMate II HeartMate III 

3.5.18 Ventracor

3.5.19 WorldHeart Novacor LVAS Device Description Clinical Experience Regulatory Status Pricing/Distribution Next Generation LVAS

3.6 Market Analysis 

3.6.1 Reimbursement 

3.6.2 Procedure Forecast Post-Cardiotomy Bridge To Transplant Destination Therapy Future Considerations 

3.6.3 Market Analysis Post-Cardiotomy Bridge To Transplant Destination Therapy

3.6.4 Competitive Analysis


Exhibit 3-1: Overview of Mechanical Circulatory Assist Options 

Exhibit 3-2: Types of Ventricular Assist Devices.

Exhibit 3-3: Importance of VAD Attributes by Potential Patient Population

Exhibit 3-4: Classification of Mechanical Circulatory Support Devices According to Disease Severity

Exhibit 3-5: Overview of VAD Indications

Exhibit 3-6: Considerations for VAD Patient Selection 

Exhibit 3-7: Overview of REMATCH Study Results

Exhibit 3-8: Selected External Ventricular Assist Products and Suppliers, 2004

Exhibit 3-9: Selected Implantable Ventricular Assist Products and Suppliers, 2004 

Exhibit 3-10: Selected Percutaneous Ventricular Assist Products and Suppliers, 2004

Exhibit 3-11: Abiomed's VAD Products 

Exhibit 3-12: A-Med Systems' pLVAD 

Exhibit 3-13: Arrow International's VAD Products 

Exhibit 3-14: Berlin Heart's VAD Products 

Exhibit 3-15: Biomedlab's AnyHeart BiVAD

Exhibit 3-16: CardiacAssist's VAD Products

Exhibit 3-17: Impella CardioSystems' VAD Products 

Exhibit 3-18: Positioning of Intra-Vasc's PUCA-pump (LVAD Configuration)

Exhibit 3-19: Jarvik Heart's Jarvik 2000 Flowmaker 

Exhibit 3-20: Levitronix' CentriMag Extracorporeal Blood Pumping System 

Exhibit 3-21: MedQuest Products' HeartQuest VAD

Exhibit 3-22: MicroMed Technology's DeBakey VAD

Exhibit 3-23: Terumo's DuraHeart LVAS

Exhibit 3-24: The Thoratec VAD System

Exhibit 3-25: Thoratec's HeartMate Product Line

Exhibit 3-26: Ventracor's VentrAssist LVAS 

Exhibit 3-27: WorldHeart's Novacor LVAS 

Exhibit 3-28: WorldHeart's Next Generation LVAS

Exhibit 3-29: The History of VAD Medicare Reimbursement

Exhibit 3-30: VAD-Related CPT Codes & Physician Payments

Exhibit 3-31: U.S. Procedure Forecast for Ventricular Assist Devices, 2002-2008

Exhibit 3-32: U.S. Market for Ventricular Assist Devices, 2002-2008 

Exhibit 3-33: U.S. Market for Ventricular Assist Devices by Device Type, 2003 & 2008 

Exhibit 3-34: U.S. Supplier Shares for Ventricular Assist Devices, 2002-2003 

Exhibit 3-35: Implantable VAD Supplier Shares, 2002-2003 

Exhibit 3-36: External VAD Supplier Shares, 2002-2003



4.1 External Counterpulsation 

4.1.1 Technique

4.1.2 Indications

4.1.3 Contraindications and Complications 

4.1.4 Reimbursement 

4.1.5 Product Description 

4.1.6 Clinical Experience Angina Pectoris Heart Failure Mechanisms of Action 

4.1.7 Products and Suppliers Cardiomedics CPC of America Living Data Technology Corp. Nicore Vasomedical

4.1.8 Product Trends

4.1.9 Market Analysis 

4.2 Intra-Aortic Balloon Pumps

4.2.1 Technology and Usage

4.2.2 Indications and Contraindications

4.2.3 Potential Complications

4.2.4 Product Trends

4.2.5 Products and Suppliers Datascope Arrow International

4.2.6 Market Analysis 

4.3 Cardiac Recovery Systems 

4.3.1 Indications

4.3.2 Products and Suppliers Orqis Medical CardiO2 (JOMED)

4.3.3 Market Analysis 

4.4 Total Artificial Hearts 

4.4.1 History

4.4.2 Indications

4.4.3 Products and Suppliers Abiomed Device Description Clinical Experience Cost Effectiveness Regulatory Status AbioCor II SynCardia Systems Device Description Clinical Experience Regulatory Status Pricing/Distribution Other Programs Tohoku University University of Tokyo Vacord Bioengineering Research Company

4.4.4 Market Analysis Bridge To Transplant Destination Therapy

4.5 Cardiac Compression

4.5.1 Products Abiomed CardioEnergetics Cardio Technologies 

4.5.2 Market Analysis 

4.6 Counterpulsating Ventricular Assist Technologies 

4.6.1 Intra-Aortic Ventricular Assist Device (CardioVad) Design and Implantation Operation and Benefits Clinical Experience Commercialization Plans 

4.6.2 Extra-Aortic Counterpulsation Devices Harefield Cardiac Sunshine Heart

4.6.3 Market Analysis 


Exhibit 4-1: Overview Mechanical Circulatory Support Technologies

Exhibit 4-2: Schematic of Extracorporeal Counterpulsation 

Exhibit 4-3: Indications and Contraindications for ECP

Exhibit 4-4: Selected External Counterpulsation Therapy Systems in Use

Exhibit 4-5: Potential Mechanisms for Clinical Effectiveness of ECP

Exhibit 4-6: Selected External Counterpulsation Systems, 2004

Exhibit 4-7: External Counterpulsation, Patient and Market Forecast, 2002-2008 

Exhibit 4-8: External Counterpulsation Systems, Supplier Shares, 2003

Exhibit 4-9: Indications & Contraindications for IABP Therapy 

Exhibit 4-10: Benchmark Registry: Indications for IABP Therapy

Exhibit 4-11: Benchmark Registry: Complications Associated with IAPB Therapy

Exhibit 4-12: Selected Intra-Aortic Balloon Pump Products, 2004

Exhibit 4-13: Datascope CS100 Controller and Fidelity Catheter

Exhibit 4-14: Arrow International AutoCAT 2 WAVE and Light WAVE Catheter

Exhibit 4-15: Intra-Aortic Balloon Pumps and Controllers, Market Forecast, 2002-2008

Exhibit 4-16: Intra-Aortic Balloon Pumps, Supplier Shares, 2003

Exhibit 4-17: Cardiac Recovery Systems, Products and Suppliers, 2004

Exhibit 4-18: Orqis Medical's Cancion Cardiac Recovery System

Exhibit 4-19: CardiO2's Reitan Catheter Pump

Exhibit 4-20: U.S. Market for Cardiac Recovery Systems, 2004-2008

Exhibit 4-21: Selected Total Artificial Heart Programs, 2004

Exhibit 4-22: Abiomed's AbioCor Implantable Replacement Heart

Exhibit 4-23: SynCardia Systems' CardioWest Total Artificial Heart

Exhibit 4-24: Selected Clinical Outcomes of the CardioWest Total Artificial Heart

Exhibit 4-25: Selected Development Stage TAH Devices 

Exhibit 4-26: U.S. Procedure Forecast for Total Artificial Hearts, 2003-2008 

Exhibit 4-27: U.S. Market Forecast for Total Artificial Hearts, 2003-2008

Exhibit 4-28: Selected Cardiac Compression Devices, 2004

Exhibit 4-29: CardioEnergetics' RePower Device 

Exhibit 4-30: Selected Counterpulsating Ventricular Assist Technologies, 2004

Exhibit 4-31: Kantrowitz CardioVad Counterpulsating Ventricular Assist Device 

Exhibit 4-32: Harefield Cardiac AK-Pulsator

Exhibit 4-33: Sunshine Heart Extra-Aortic Balloon Counterpulsation Device 

Exhibit 4-34: Counterpulsating Ventricular Assist Devices, Patient and Market Forecast 2007-2008 



5.1 Cardiac Transplantation 

5.1.1 Cardiac Transplant Statistics

5.1.2 Transplant Forecast

5.2 Dynamic Cardiomyoplasty 

5.2.1 Patient Indications

5.2.2 Risk Factors 

5.2.3 Clinical Outcomes

5.2.4 Limitations 

5.3.5 Emerging Protocols

5.2.6 ACC/AHA Guidelines and Clinical Prospects 

5.2.7 Products and Suppliers Medtronic Pacetronic Corporation 

5.2.8 Market Analysis 

5.3 Left Ventricular Volume Reduction 

5.3.1 Procedure 

5.3.2 Indications

5.3.3 Clinical Outcomes

5.3.4 Procedure Volume 

5.4 Ventricular Reconstruction and Restoration

5.4.1 Techniques Endovascular Circular Patch Plasty Septal Anterior Ventricular Exclusion

5.4.2 Surgical Ventricular Restoration Clinical Experience (RESTORE and STICH Trials) SVR Products Chase Medical CHF Technologies Somanetics Procedure Trend Market Analysis 

5.5 Less Invasive Surgical Cardiac Support 

5.5.1 Acorn Cardiovascular 

5.5.2 CardioEnergetics/CardioClasp

5.5.3 Myocor

5.5.4 Paracor Medical 

5.5.5 Procedure and Market Forecast 

5.6 Percutaneous Mitral Valve Repair and Replacement 

5.6.1 Percutaneous Annuloplasty

5.6.2 Percutaneous Valve Repair 

5.6.3 Percutaneous Valve Replacement

5.6.4 Products and Suppliers

5.7 Device-Based Fluid Reduction Strategies 

5.7.1 Potential Risks of Chronic Diuretic Therapy

5.7.2 Device-Based Fluid Reduction Ultrafiltration (CHF Solutions) System100 Components Clinical Experience Pricing and Reimbursement Active Renal Infusion (FlowMedica) Benephit Infusion System Indications Application to Heart Failure Clinical Experience Company Background Patient Trend and Market Analysis


Exhibit 5-1: Indications for Cardiac Transplantation

Exhibit 5-2: Selected Cardiac Transplant Data, 1995 and 2003 

Exhibit 5-3: Historical Trend in Cardiac Transplant Procedures, 1994-2003 

Exhibit 5-4: Cardiac Transplants, Procedure Forecast, 2002-2008 

Exhibit 5-5: Selected Cardiomyostimulators for Dynamic Cardiomyoplasty, 2004 

Exhibit 5-6: Potential Roll Out Scenario for Demand Cardiomyostimulator Market, 2006-2008

Exhibit 5-7: Selected Surgical Ventricular Restoration Systems, 2004

Exhibit 5-8: Chase Medical TR3ISVR System 

Exhibit 5-9: TR3ISVR Procedure

Exhibit 5-10: CHF Technologies' CHFT Sizer/Shaper and Patch

Exhibit 5-11: Somanetics' CorRestore Patch Implant 

Exhibit 5-12: Area Map of HF Patients, Major Causes and Selected Therapies 

Exhibit 5-13: Surgical Ventricular Restoration, Procedure and Market Forecast, 2002-2008

Exhibit 5-14: SVR Systems, Supplier Shares, 2003 

Exhibit 5-15: Selected Minimally Invasive Surgical Cardiac Support Devices, 2004 

Exhibit 5-16: Acorn Cardiovascular CorCap Cardiac Support Device 

Exhibit 5-17: CardioClasp Device 

Exhibit 5-18: Myocor Myosplint Device 

Exhibit 5-19: Minimally Invasive Surgical Cardiac Support, Procedure & Market Forecast, 2002-2008

Exhibit 5-20: Percutaneous Approaches to Valve Disease Management 

Exhibit 5-21: Selected Percutaneous Valve Repair and Replacement Programs, 2004 

Exhibit 5-22: Selected Device-Based Fluid Reduction Technologies, 2004 

Exhibit 5-23: CHF Solutions' System 100

Exhibit 5-24: FlowMedica Benephit Infusion System

Exhibit 5-25: Device-Based Fluid Reduction, Market Forecast, 2002-2008



6.1 Cell Transplantation Therapy 

6.1.1 Approaches Cardiomyocytes Skeletal Myoblasts Stem cells 

6.1.2 Products and Suppliers Advanced Cell Technology Angiogene BioCardia Bioheart Cell Transplants International Diacrin (GenVec) Genzyme Biosurgery Medtronic Osiris Therapeutics 

6.1.3 Market Potential

6.2 Gene Therapy

6.2.1 Vectors for Gene Delivery 

6.2.2 Mechanisms of Cardiac Gene Delivery 

6.2.3 Gene Therapy Programs to Treat Heart Failure

6.2.4 Therapeutic Angiogenesis

6.2.5 Future Directions of Gene Therapy 


Exhibit 6-1: Approaches to Heart Failure Cell Transplantation 

Exhibit 6-2: Selected Human Clinical Studies of Skeletal Myoblast-Based Cardiac Cell Transplantation 

Exhibit 6-3: Incidence of Arrhythmia in Cardiac Cell Transplantation

Exhibit 6-4: Selected Animal Studies Evaluating Cardiac Stem Cell Transplantation 

Exhibit 6-5: Advantages and Disadvantages of Various Approaches in Cardiac Cell Transplantation Therapy 

Exhibit 6-6: Selected Human Clinical Studies of Cardiac Stem Cell Transplantation 

Exhibit 6-7: Selected Cell Based Therapies for Heart Failure, 2004

Exhibit 6-8: U.S. Procedure and Market Forecast for Cardiac Cell Transplantation, 2007-2008 

Exhibit 6-9: Properties of Vector Systems for Gene Transfer 

Exhibit 6-10: Approaches to Cardiac Gene Delivery 

Exhibit 6-11: Selected U.S. Gene Therapy Programs Related to Heart Failure, 2004 

Exhibit 6-12: Selected Angiogenesis Programs for Ischemic/Coronary Heart Disease, 2004



7.1 Abiomed, Inc

7.2 Angiogene

7.3 Arrow International, Inc

7.4 Bioheart, Inc

7.5 BioSite, Inc. 

7.6 Collateral Therapeutics, Inc. 

7.7 Datascope Corporation

7.8 GenVec, Inc. (Diacrin, Inc.)

7.9 Guidant Corporation 

7.10 Impulse Dynamics NV

7.11 Medtronic, Inc

7.12 Osiris Therapeutics, Inc. 

7.13 St. Jude Medical, Inc

7.14 Thoratec Corporation 

7.15 Vasomedical, Inc

7.16 WorldHeart Corporation 


* Note: Numerous small competitors are profiled in their technology descriptions.




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