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TABLE OF CONTENTS
SECTION
1: EXECUTIVE SUMMARY
1.1
Congestive Heart Failure Overview
1.2
Current Management of Congestive Heart Failure
1.3
Biventricular Pacing/ICD Therapy
1.4
Ventricular Assist Devices
1.5
Emerging Technologies
1.5.1
Total Artificial Hearts
1.5.2
Emerging Stem Cell and Gene Therapies
1.5.3
Gene Therapy Technologies
1.6
Ventricular Remodeling
SECTION
2: CLINICAL AND STATISTICAL OVERVIEW
2.1
Etiology of Congestive Heart Failure
2.1.1
Types of Heart Failure
2.1.2
Epidemiology
2.1.3
Reasons for Onset
2.1.3.1 Atherosclerosis
2.1.3.1.1 Complications
2.1.3.2 Myocardial Infarction
2.1.3.3 Hypertension
2.1.3.4 Cardiomyopathy
2.1.3.5 Atrial Fibrillation
2.1.3.6 Other Causes of Heart Failure
2.2
Classifying Heart Failure
2.3
Current Management of Congestive Heart Failure
2.3.1
Drug Therapy
2.3.1.1 CHF Drug Market
2.3.1.2 Interaction of Drugs on Devices
2.3.1.3 Limitations
2.3.2
Bridge to Transplant
2.3.2.1 Bridge to Transplant Limitations
2.3.3
Transplantation
2.3.3.1
Limitations
2.3.3.1.1
Organ Donor Shortage
2.4
Prevalence of CHF
SECTION
3: BIVENTRICULAR PACING/ICD THERAPY
3.1
Overview
3.1.1
Heart Electrical Activity
3.1.2
Electrical Distortions in CHF Patients
3.1.3
Procedural Description
3.1.3.1
Limitations
3.1.4
Clinical Indications
3.1.5
Outcome – Cardiac Resynchronization Clinical Trials
3.1.5.1
MUSTIC Trial
3.1.6
Potential Role for Implantable Cardiac Defibrillators
3.2
Biventricular/ICD Systems
3.2.1
Medtronic
3.2.1.1
InSync CRS
3.2.1.1.1
MIRACLE Trial
3.2.1.2
InSync ICD System
3.2.1.2.1
MIRACLE ICD Trial
3.2.1.3
InSync III System
3.2.1.3.1
InSync III Study
3.2.1.4
Chronicle Device
3.2.1.5
MEDTRONIC’s Product Portfolio
3.2.2
Guidant Corporation
3.2.2.1
CONTAK CD
3.2.2.1.1
VENTAK CHF/CONTAK CD Study
3.2.2.2
CONTAK TR System
3.2.2.2.1
COMPANION Study
3.2.2.3
CONTAK RENEWAL CRT-D System
3.2.2.4
CONTAK RENEWAL 2 System
3.2.3
St. Jude Medical
3.2.3.1
Dynamic Atrial Overdrive (DAO) algorithm
3.2.3.2
ST. JUDE Clinical Trials
3.2.3.2.1
Post AV Node Ablation Evaluation
(PAVE) Trial
3.2.3.2.2
Ventricular Resynchronization Therapy Randomized (VecToR)
3.2.4
ELA MEDICAL
3.2.5
BIOTRONIK GmbH & Co
3.3
Market Assessment/Forecast
SECTION
4: VENTRICULAR ASSIST DEVICES
4.1
Pulsatile Pumps
4.1.1
Thoratec Corporation
4.1.1.1
Thoratec VAD System
4.1.1.2
TLC-II Driver
4.1.1.3
Thoratec IVAD System
4.1.1.4
HeartMate Systems
4.1.1.4.1
HeartMate IP System
4.1.1.4.2
HeartMate VE LVAS System
4.1.1.4.3
REMATCH Trial
4.1.1.4.4
REMATCH Discussion
4.1.1.5
Pipeline Products
4.1.2
Baxter Novacor/WorldHeart
4.1.3
Novacor LVAS System
4.1.3.1
INTrEPID Trial
4.1.3.2
PTFE Inflow Grafts
4.1.3.3
HeartSaver VAD
4.1.3.4
HeartSaver II
4.1.3.5
Novacor II
4.1.4
Arrow International
4.1.5
L.VAD Technology
4.1.6
Berlin Heart AG
4.1.6.1
Berlin Heart EXCOR Pump
4.1.6.2
INCOR II
4.1.7
Biomedlab Co. Ltd
4.1.8
Prototypes
4.2
Rotary Pumps
4.2.1
Axial Flow Pumps
4.2.1.1
MicroMed Technology
4.2.1.2
Cardionove
4.2.1.3
Berlin Heart AG
4.2.1.4
Jarvik Heart, Inc
4.2.1.4.1
Clinical Trials
4.2.1.4.2
Limitations
4.2.1.4.3
Future Developments
4.2.1.5
Thoratec Corporation
4.2.1.6
Other Systems
4.2.2
Centrifugal Flow Pumps
4.2.2.1
Thoratec Corporation
4.2.2.2
Arrow International
4.2.2.3
MicroMedical Industries
4.2.2.4
MedQuest Products, Inc
4.2.2.5
Kriton Medical Inc
4.2.2.6
Terumo Corporation
4.2.2.7
Other Systems
4.2.3
Cardiac Biological Assist
4.2.3.1
Abiomed
4.2.3.2
Whalen Biomedical
4.2.3.3
Other Applications
4.2.4
Market Assessment
SECTION
5: EMERGING TECHNOLOGIES
5.1
Total Artificial Heart
5.1.1
Total Artificial Heart Systems
5.1.1.1
ABIOMED
5.1.1.2
CARDIOWEST TECHNOLOGIES
5.1.1.3
BIOMEDLAB CO.
5.1.1.4
Other Devices
5.1.2
Therapies for End-Stage Heart Failure that Impact
on Need for TAH
5.1.2.1
Allotransplantation
5.1.2.2
Surgical Procedures
5.1.2.3
Xenotransplantation
5.1.2.4
Cellular Transplantation
5.1.2.5
Organogenesis and Tissue Engineering
5.1.3
Obstacles Remaining to Successful Implementation
of TAHs
5.1.3.1
Thromboembolism
5.1.3.2
Hemorrhage
5.1.3.3
Infection
5.1.3.4
Multiple Organ Failure
5.1.3.5
Device Malfunction
5.1.4
The Cost Controversy
5.1.5
Potential Market for TAHs
5.2
Emerging Stem Cell and Gene Therapies for CHF-Related
Indications
5.2.1
Stem Cell-Based Technologies
5.2.1.1
Embryonic Stem Cells
5.2.1.2
Adult Stem Cells
5.2.1.3
Preclinical Experience with Stem Cell-Based
Cardiac Tissue
Regeneration
5.2.1.4
CHF-Related Cellular Repair Therapies in
Trials and Under
Development
5.2.1.4.1
BIOHEART
5.2.1.4.2
DIACRIN
5.2.1.4.3
GENZYME CORPORATION
5.2.1.4.4
OSIRIS THERAPEUTICS
5.2.1.4.5
GERON CORPORATION
5.2.1.4.6
ADVANCED CELL TECHNOLOGY
5.2.2
Gene Therapy Technologies for CHF-Related
Indications
5.2.2.1
Therapeutic Angiogenesis
5.2.2.1.1
COLLATERAL THERAPEUTICS
5.2.2.1.2
CHIRON CORPORATION
5.2.2.1.3
GENVEC
5.2.2.1.4
GENZYME CORPORATION
5.2.2.1.5
MICROMED TECHNOLOGY
5.2.2.1.6
REGENERON
5.2.2.1.7
VALENTIS
5.2.2.1.8
VASCULAR GENETICS
5.2.2.2
Enhancement of Myocardial Contractile
Function and Prevention of
Degenerative
Ventricular Remodeling in CHF Setting
5.2.2.2.1
COLLATERAL THERAPEUTICS
5.2.2.2.2
Duke University Medical Center
5.2.2.2.3
Massachusetts General Hospital
5.2.2.2.4
FIBROGEN
5.2.2.2.5
University of Pittsburgh
5.2.2.3
Potential Applications of Gene Therapy in
Heart Tissue
Regeneration
5.2.2.3.1
COLLATERAL THERAPEUTICS
5.2.3
Potential U.S. Markets for CHF-Targeting Stem Cell
and Gene
Therapy Technologies
5.3
Ventricular Remodeling
5.3.1
Novel Surgical Ventricular Remodeling Therapies for
CHF
Indications
5.3.2
Remodeling Device-Based Techniques
5.3.2.1
ACORN CARDIOVASCULAR
5.3.2.2
ABIOMED
5.3.2.3
MYOCOR
5.3.2.4
SOMANETICS
5.3.3
Potential U.S. Market for CHF-Targeting Ventricular
Remodeling
Devices
SECTION
6: COMPANY PROFILES
6.1
ABIOMED, INC
6.2
ACORN CARDIOVASCULAR, INC
6.3
ADVANCED CELL TECHNOLOGY, INC
6.4
ARROW INTERNATIONAL, INC.
6.5
BERLIN HEART AG
6.6
BIOHEART, INC.
6.7
COLLATERAL THERAPEUTICS, INC.
6.8
GENVEC, INC.
6.9
GERON CORPORATION
6.10
GUIDANT CORPORATION.
6.11
L.VAD TECHNOLOGY, INC.
6.12
MEDQUEST PRODUCTS, INC.
6.13
MEDTRONIC, INC.
6.14
MICROMED TECHNOLOGY, INC.
6.15
MICROMEDICAL INDUSTRIES, LTD.
6.16
SOMANETICS CORPORATION
6.17
ST. JUDE MEDICAL, INC
6.18
THORATEC CORPORATION
6.19
WORLD HEART CORPORATION
APPENDIX
A: COMPANY LISTING
LIST
OF EXHIBITS
Exhibit
1-1: Estimated Direct and Indirect Costs of
Cardiovascular
Diseases and Stroke, U.S. 2001
Exhibit
1-2: Current Treatment Regimens for CHF Based on
NYHA
Classification
Exhibit
1-3: Patient Population and Trial Design of CRT Trials
Exhibit
1-4: Major Players in CRT/ICD
Exhibit
1-5: Cardiac Resynchronization/ICD Therapy, U.S.
Market Forecast
2001E-2010E U.S.
Exhibit
1-6: VAD Bridge to Transplant Patients: Survival and
Recovery
Rates
Exhibit
1-7: Differences Between Pulsatile and Rotary Pumps
Exhibit
1-8: Differences and Similarities Between Axial and
Centrifugal
Rotary Pumps
Exhibit
1-9: Centrifugal Pumps Under Development and
Investigation
Exhibit
1-10: Biological Assist Support: Limitations and
Future
Exhibit
1-11: Forecast Sales for U.S. Ventricular Assist
Devices,
2000-2006E
Exhibit
1-12: Analysis of Recent VAD Acquisitions
Exhibit
1-13: Ventricular Assist Devices, U.S. Market
Forecast 2000-2010E
U.S.
Exhibit
1-14: Selected Total Artificial Heart Devices Under
Development
and in Clinical Testing
Exhibit
1-15: U.S. Potential Market, Total Artificial Hearts,
2006E-2010E
Exhibit
1-16: Selected CHF-Related Cellular
Repair/Regeneration
Technologies Under
Development
Exhibit
1-17: Projected U.S. Markets for CHF-Related Stem
Cell and Gene
Therapy Products, 2000-2010E
Exhibit
1-18: Selected Ventricular Remodeling Devices for
CHF-Related
Indications Under Development
Exhibit
1-19: Potential Market for CHF-Targeting Ventricular
Remodeling
Devices, 2001-2010E
Exhibit
2-1: Normal Blood Flow Through the Heart and Body
Exhibit
2-2: Classifications of Heart Failure
Exhibit
2-3: Prevalence of CHF, by Age, U.S.
Exhibit
2-4: Deaths From Congestive Heart Failure, U.S.,
1968-1998
Exhibit 2-5: Estimated Direct and Indirect Costs of
Cardiovascular Diseases and Stroke, U.S. 2001
Exhibit
2-6: Cardiovascular Disorders Associated with
Congestive Heart
Failure
Exhibit
2-7: NYHA Classification System for Heart Failure
Exhibit
2-8: Current Treatment Regimens for CHF Based on
NYHA
Classification
Exhibit
2-9: CHF Patient Breakdown Based on NYHA Class
Exhibit
2-10: One-Year CHF Mortality Based on NYHA
Classification
Exhibit
2-11: CHF Risk Factor Management
Exhibit
2-12: Mechanisms of Action for Current CHF Drug
Therapies
Exhibit
2-13: Trend in Heart Transplants, U.S., 1968-2000
Exhibit
2-14: Survey of Americans’ Attitudes on Organ
Shortage and
Transplantation
Exhibit
2-15: U.S. Estimated and Projected Incidence and
Prevalence of CHF
Exhibit
3-1: The Heart’s Electrical System
Exhibit
3-2: Obstacles Associated with CRT
Exhibit
3-3: Patient Population and Trial Design of CRT Trials
Exhibit
3-4: Comparison of Completed CRT Trials
Exhibit
3-5: The MUSTIC Trial – Six-Minute Hall Walk
Exhibit
3-6: The MUSTIC Trial – Quality of Life (based on
Minnesota
Living with HF Questionnaire)
Exhibit
3-7: The MUSTIC Trial – Rate of Hospitalizations
Exhibit
3-8: ICD Trials
Exhibit
3-9: CRT/ICD Combination Trials
Exhibit
3-10: InSync CRS
Exhibit
3-11: Major Players in CRT/ICD
Exhibit
3-12: MIRACLE Trial Design
Exhibit
3-13: The MIRACLE Trial – Percent Improvement from
Baseline to
Six-Month Follow-up
Exhibit
3-14: Patients in MIRACLE-ICD Trial by NYHA Class
Exhibit
3-15: Inclusion/Exclusion Criteria for the MIRACLE
ICD Trial
Exhibit
3-16: Portfolio of MEDTRONIC’s Heart Failure
Initiative
Exhibit
3-17: FDA Panel Concerns Regarding GUIDANT’s
CONTAK CD Trial
Exhibit
3-18: CONTAK CD
Exhibit
3-19: VENTAK CHF/CONTAK CD Trial Design
Exhibit
3-20: Expanded Composite Index Analysis for
CONTAK CD Trial
Exhibit
3-21: CONTAK TR
Exhibit
3-22: The COMPANION Study Design
Exhibit
3-23: Genesis System Components
Exhibit
3-24: Comparative Overview of ELA MEDICAL
Products
Exhibit
3-25: Cardiac Resynchronization/ICD Therapy, U.S.
Market Forecast
2001E-2010E U.S.
Exhibit
4-1: VAD Bridge to Transplant Patients: Survival and
Recovery
Rates
Exhibit
4-2: Potential Number of VAD Patients in the U.S.
Exhibit
4-3: Thoratec VAD
Exhibit
4-4: THORATEC Key Milestones into Early 2002
Exhibit
4-5: TLC-II Portable Driver
Exhibit
4-6: Thoratec IVAD
Exhibit
4-7: HeartMate IP
Exhibit
4-8: HeartMate VE
Exhibit
4-9: Randomized Evaluation of Mechanical Assistance
for the
Treatment of Congestive Heart
Failure (REMATCH) Criteria
Exhibit
4-10: REMATCH Timeline 2001
Exhibit
4-11: The REMATCH Trial - Overall Results
Exhibit
4-12: The REMATCH Trial – LVAD Specific Adverse
Events
Exhibit
4-13: The REMATCH Trial – Causes of Death
Exhibit
4-14: Comparison of HeartMate Systems by Volumes
and Masses
Exhibit
4-15: Description and Status of THORATEC
CORPORATION Products
Exhibit
4-16: Novacor LVAS
Exhibit
4-17: HeartSaver VAD
Exhibit
4-18: Description and Status of WORLDHEART
Products
Exhibit
4-19: LionHeart VAS
Exhibit
4-20: Description and Status of ARROW’s LionHeart
LVAS
Exhibit
4-21: Kantrowitz CardioVad
Exhibit
4-22: Findings of the Kantrowitz CardioVad Phase I
Study
Exhibit
4-23: EXCOR
Exhibit
4-24: INCOR II
Exhibit
4-25: Description and Status of BERLIN HEART
Products
Exhibit
4-26: IVAD
Exhibit
4-27: Pulsatile Pumps Under Development and
Investigation
Exhibit
4-28: Advantages and Disadvantages of Continuous
Flow Rotary Blood
Pumps
Exhibit
4-29: Differences Between Pulsatile and Rotary
Pumps
Exhibit
4-30: Differences and Similarities Between Axial and
Centrifugal
Rotary Pumps
Exhibit
4-31: Schema of Axial Flow Pump
Exhibit
4-32: DeBakey VAD
Exhibit
4-33: INCOR I
Exhibit
4-34: Jarvik 2000
Exhibit
4-35: HeartMate II
Exhibit
4-36: Axial Flow Pumps Under Development and
Investigation
Exhibit
4-37: Centrifugal Pump
Exhibit
4-38: HeartMate III
Exhibit
4-39: CorAide
Exhibit
4-40: In Vivo Summary Table of CorAide VAD, Results
from June 1999
Exhibit
4-41: VentrAssist
Exhibit
4-42: HeartQuest
Exhibit
4-43: Centrifugal Pumps Under Development and
Investigation
Exhibit
4-44: Biological Assist Support: Limitations and
Future
Exhibit
4-45: Biological Assist Technology Under
Development
Exhibit
4-46: Forecast Sales for U.S. Ventricular Assist
Devices,
2000-2006E
Exhibit
4-47: Potential Number of VAD Patients in the U.S.
Exhibit
4-48: Analysis of Recent VAD Acquisitions
Exhibit
4-49: VAD Market Share Based on Revenues and Unit
Sales, 2000 and
2001E
Exhibit
4-50: Differentiating Between Currently Marketed
VADs
Exhibit
4-51: Ventricular Assist Devices, U.S. Market
Forecast 2000-2010E U.S
Exhibit
5-1: Landmarks in the Development of the Artificial
Heart
Exhibit
5-2: Selected Total Artificial Heart Devices Under
Development and
in Clinical Testing
Exhibit
5-3: ABIOMED's AbioCor Implantable Replacement
Heart
Exhibit
5-4: Cost Effectiveness of the AbioCor Device versus
Transplantation
Exhibit
5-5: The CARDIOWEST Total Artificial Heart and
Circulatory Support
System IIIF
Exhibit
5-6: BIOMEDLAB AnyHeart Device
Exhibit
5-7: Therapies for End-Stage Heart Failure that
Impact Need for TAHs
Exhibit
5-8: Primary Obstacles to Attaining Goal of Clinically
Useful TAHs
Exhibit
5-9: U.S. Potential Market, Total Artificial Hearts,
2006E-2010E
Exhibit
5-10: Selected CHF-Related Cellular
Repair/Regeneration
Technologies Under
Development
Exhibit
5-11: Selected CHF-Related Angiogenic Therapy
Technologies in
Trials and Under Development
Exhibit
5-12: Novel Non-Angiogenic Gene Therapy
Technologies for CHF
Indications Under
Development
Exhibit
5-13: Projected Dynamics of CHF-Related Stem Cell
and Gene
Therapy Procedures 2000-2010E
Exhibit
5-14: Projected U.S. Markets for CHF-Related Stem
Cell and Gene
Therapy Products, 2000-2010E
Exhibit
5-15: Selected Ventricular Remodeling Devices for
CHF-Related
Indications Under Development
Exhibit
5-16: Potential Market for CHF-Targeting Ventricular
Remodeling
Devices, 2001-2010E
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