Table
of Contents
EXECUTIVE SUMMARY
I.
Novel Coronary Revascularization Systems
Ia.
Transmyocardial Revascularization
Ib.
Photoangioplasty
Ic.
Therapeutic Angiogenesis
II.
Emerging Stroke Prevention Systems
III.
AAA Stent Graft Systems
IV.
Vascular Puncture Closure Devices (VPCD)
Section 1:
Cardiovascular Disorders - Clinical and Statistical
Overview
1.1 Etiology of
Cardiovascular Disease
1.2
Prevalent
Cardiovascular Diseases Targeted by Novel Therapies
1.2.1
Atherosclerosis
1.2.1.1
Complications Associated with Atherosclerosis
1.2.1.2
Causes and Mechanisms
1.2.2
Ischemic Heart Disease
1.2.3
Angina Pectoris
1.2.3.1
Characterizing Angina
1.2.3.1.1 Stable
Angina
1.2.3.1.2
Variant/Prinzmetal
Angina
1.2.3.2
Classifying Angina and Treatment Options
1.2.4
Acute Myocardial Infarction
1.2.4.1
Treatment for AMI
1.2.5
Aortic Aneurysms
1.2.5.1
AA Treatment
1.2.5.1.1 Surgical
Intervention
1.2.5.1.2
Endovascular
Approach
1.2.6
Stroke
1.2.6.1
Cerebral Thrombosis and Embolism
1.2.6.2
Hemorrhagic Stroke
1.2.6.3
Incidence and Treatment of Stroke
1.2.7
Deep Venous Thrombosis and Pulmonary Embolism
1.2.7.1
Thrombogenic Stimuli
1.2.7.2
Pulmonary Embolism
1.2.8
Congestive Heart Failure
1.2.8.1
CHF Management
Section 2:
Established and Emerging Interventional Therapies for
Major Life-Threatening Cardiovascular Disorders
2.1
Management of
Advanced Coronary Artery Disease
2.1.1
Coronary Artery Bypass Graft Surgery
2.1.1.1
Less Invasive Techniques
2.1.1.1.1
“Off-Pump”
CABG
2.1.1.1.2
Minimally
Invasive Direct CABG
2.1.1.1.3
Port
Access CABG
2.1.1.2
Clinical Indications
2.1.1.2.1
Complications
and Outcome
2.1.1.2.2
Associated
Risk Factors
2.1.1.2.3
CABG
vs. PTCA
2.1.1.3
End-User Trends and Procedure Volumes
2.1.1.3.1
Penetration
Forecast
2.1.2
Percutaneous Transluminal Coronary Angioplasty/Stenting
2.1.2.1
Advent of Stenting
2.1.2.2
Clinical Indications and Outcomes
2.1.2.3
End-Use Trends
2.1.2.3.1
Procedural
Volumes
2.1.2.3.2
Emerging
Therapies
2.1.3
Transmyocardial Revascularization
2.1.3.1
Procedural Details
2.1.3.2
Percutaneous Transmyocardial Revascularization
2.1.3.3
Clinical Indications
2.1.3.3.1
Projected
Patient Volume
2.1.3.4
Outcomes
2.1.3.5
Transmyocardial Revascularization Systems on the
Market and Under Development
2.1.3.5.1
Laser-Based
TMR & PTMR Systems
2.1.3.5.1.1
PLC
Medical
2.1.3.5.1.2
Eclipse
Surgical Technologies
2.1.3.5.1.2.1
PTMR Axcis System
2.1.3.5.2
Biosense
Webster
2.1.3.5.3
Radiofrequency
Ablation-Based PTMR Systems
2.1.3.5.3.1
Boston
Scientific
2.1.3.5.3.2
Radius
Medical
2.1.3.5.4 Mechanical
PTMR Technology
2.1.3.5.4.1
Angiotrax
2.1.3.5.5
Other
Emerging Competitors
2.1.4
Photoangioplasty
2.1.4.1
Principles and Mechanisms of Photoangioplasty
2.1.4.1.1
Acute
Effects and Desired Characteristics
2.1.4.2
Photoangioplasty Products Under Development and Trial
Results
2.1.4.2.1 Pharmacyclics
2.1.4.2.1.1
Preclinical
Antrin Studies
2.1.4.2.1.2
Clinical
Studies Using Antrin
2.1.4.2.1.2.1
Peripheral
Artery Disease
2.1.4.2.1.3
Coronary
Artery Disease
2.1.4.2.2 Miravant
Medical Technologies
2.1.4.2.3
QLT
Photo Therapeutics Inc.
2.1.4.2.4
Other
Emerging Companies
2.1.4.2.5
Alternative
Photodynamic Agent
2.1.5
Therapeutic Angiogenesis
2.1.5.1 Principles and Types of Therapeutic Angiogenesis
2.1.5.2 Therapeutic Angiogenesis Products Under Development
& Trial Results
2.1.5.2.1
Genentech
2.1.5.2.2
Chiron
Corporation
2.1.5.2.3
Vascular
Genetics
2.1.5.2.4
Collateral
Therapeutics
2.1.5.2.5
GenVec
2.1.5.3 Hybrid Angiogenesis-PTMR Therapies
2.1.5.3.1
Vascular
Genetics/Biosense Webster
2.1.5.3.2 Vical/Boston
Scientific
2.1.5.3.3 Cardiodyne
2.2
Management of Carotid Artery Occlusion and Stroke
Prevention
2.2.1
Carotid Endarterectomy
2.2.1.1
Clinical Indications and Outcomes
2.2.1.1.1 NASCET
and ACAS Studies
2.2.1.1.2
Study
Limitations
2.2.1.2 CEA Procedure Volumes
2.2.2
Carotid Artery Stenting
2.2.2.1
Targeted Indications
2.2.2.2
Clinical Trial Results
2.2.2.2.1 U.S.
Data
2.2.2.2.1.1
Findings
Challenged
2.2.2.2.2
CREST
Trial Design
2.2.2.2.2.1
Potential
Market Impact
2.2.2.3 Carotid Stenting Systems Under Development
2.2.2.3.1
Bard
Peripheral Technologies
2.2.2.3.2
Boston
Scientific
2.2.2.3.3 Cordis
2.2.2.3.4
Guidant
2.2.2.3.5 Medtronic
AVE
2.2.2.3.6
Other
Market Participants
2.2.3
Embolic Containment Systems
2.2.3.1
Targeted Indications
2.2.3.2
Outcomes
2.2.3.3
Embolic Containment Systems Under Development
2.2.3.3.1
Cordis
2.2.3.3.2
Boston
Scientific
2.2.3.3.3
Smaller
Market Participants
2.2.3.3.3.1
Embolic
Protection, Inc.
2.2.3.3.3.2
Kensey
Nash
2.2.3.3.3.3
Microvena
Corporation
2.2.3.3.3.4
Percusurge
2.2.3.3.4
Other
Market Participants
2.3
Abdominal Aortic Aneurysms
2.3.1
Surgical Repair of Abdominal Aortic Aneurysms
2.3.2
Aortic Aneurysm Repair With Endovascular Stent-Grafts
2.3.2.1
Necessary Requirements for Successful SG Systems
2.3.2.2
Limitations of Endovascular AAA Repair
2.3.2.2.1
Endoleaks
2.3.2.2.1.1
Preventing
Endoleaks
2.3.2.2.1.2
Outcomes
from Endoleaks
2.3.2.2.2
Endotension
2.3.2.3
AAA Devices on the Market and Under Development
2.3.2.3.1
Guidant
2.3.2.3.1.1
Clinical
Trial
2.3.2.3.2
Medtronic
AVE
2.3.2.3.2.1
AneuRx
Stent Graft System
2.3.2.3.2.2
Talent
SG
2.3.2.3.3
W.L.
Gore
2.3.2.3.4
Boston
Scientific
2.3.2.3.5
Cook
2.3.2.3.6
Cordis
2.3.2.3.7
Edwards
Lifesciences
2.3.2.3.8
Sulzer
Vascutek
2.4
Vascular Puncture Closure Systems
2.4.1
Traditional Methods of Closure
2.4.1.1
Limitations and Complications
2.4.2
Vascular
Puncture Closure Devices on the Market and Under Development
2.4.2.1
Suture-Mediated Closure Systems
2.4.2.1.1
Abbott
Laboratories
2.4.2.1.1.1
The Closer
2.4.2.1.2
Sutura
2.4.2.1.3
X-Site
2.4.2.1.4
Scion
2.4.2.2
Collagen Plug Devices
2.4.2.2.1
St.
Jude Medical/Kensey Nash
2.4.2.2.2
Datascope
2.4.2.3
Combination Products
2.4.2.3.1
Vascular
Solutions
Section 3:
Emerging U.S. Markets for Novel Cardiovascular
Interventional Products
3.1
Coronary
Revascularization Systems
3.1.1
Transmyocardial Revascularization Product Markets
3.1.1.1
Projected Growth
3.1.1.2
Supplier Market Shares
3.1.2
Photoangioplasty Therapy Market
3.1.2.1
Projected Growth
3.1.3
Therapeutic
Angiogenesis Market
3.2
Emerging Stroke
Prevention Product Markets
3.2.1
Embolic Containment Systems
3.2.2
Carotid Artery Stenting Systems
3.2.2.1
Projected Growth
3.3
Endovascular
Abdominal Aortic Aneurysm Repair Product Market
3.3.1
Market Limitations
3.3.2
Projected Growth
3.3.3
Competitive Analysis
3.4
Vascular Puncture
Closure Device Market
3.4.1
Competitive Analysis
Section 4:
Company Profiles
4.1
Abbott
Laboratories / Perclose
4.1.1
Perclose
4.2
C.R. Bard
4.3
Boston Scientific
Corporation
4.4
Collateral
Therapeutics
4.5
Datascope
Corporation
4.6
Eclipse Surgical
Technologies
4.7
Edwards
Lifesciences
4.8
Genentech
(Angiogenesis)
4.9
Guidant
Corporation
4.10
Johnson &
Johnson / Biosense Webster, Cordis
4.11
Medtronic
4.12
PercuSurge, Inc.
4.13
Pharmacyclics
4.14
PLC Systems, Inc.
4.15
St Jude Medical,
Inc.
List of
Exhibits
Exhibit
ES-1: Projected U.S. Epidemiology of Major Life-Threatening
Cardiovascular Disorders, 2000-2005-2010
Exhibit
ES-2: Projected Procedure Mix in Interventional Management of Major
Cardiovascular Disorders, 2000-2010 (#000)
Exhibit
ES-3: U.S. PTCA vs. CABG,
1999-2010
Exhibit
ES-4: U.S. Primary TMR/PTMR
vs. CABG, 1999-2010
Exhibit
ES-5: U.S. Carotid
Endarterectomies vs. Carotid Stenting, 1999-2010
Exhibit
ES-6: U.S. AAA Repair,
Surgery vs. Endograft, 1999-2010
Exhibit
ES-7: U.S. Vascular
Puncture Closure, Compression vs. Device Closure, 1999-2010
Exhibit
ES-8: U.S. Markets for Novel Cardiovascular Interventional Products,
1999-2010 ($mil)
Exhibit
ES-9: U.S. Markets for Novel Coronary Revascularization Systems,
1999-2010 ($ mil)
Exhibit
ES-10: U.S. Markets for Interventional Stroke Prevention Systems,
1999-2010
Exhibit
ES-11: U.S. Markets for AAA Endovascular Repair Systems, 1999-2010
Exhibit
ES-12: U.S. Markets for Vascular Puncture Closure Systems, 1999-2010
Exhibit
1-1: Estimated and Projected U.S. Epidemiology of Major
Life-Threatening Cardiovascular Disorders, 2000-2005-2010
Exhibit
2-1: Projected Procedure Mix in Interventional Management of Major
Cardiovascular Disorders, 2000-2010 (#000)
Exhibit
2-2: U.S. Markets for Novel Cardiovascular Interventional Products,
1999-2010 ($mil)
Exhibit
2-3: Schema of Surgical TMR
Exhibit
2-4: “Outside-In” Channels of TMR
Exhibit
2-5: Schema of PTMR
Exhibit
2-6: “Inside-Out”
Channels
Exhibit
2-7: Eclipse’s TMR 2000
Exhibit
2-8: Solo-Grip
Exhibit
2-9: Axcis Laser Catheter
Exhibit
2-10: DMR System
Exhibit
2-11: 3D Map
Exhibit
2-12: PeRFmr Catheter
Exhibit
2-13: Participants in the Emerging TMR/PTMR Market
Exhibit
2-14:
Photoangioplasty/Vascular Photodynamic Therapy Systems Under
Development
Exhibit
2-15: AutoFire System
Exhibit
2-16: AutoFire Catheter
Exhibit
2-17: Selected Therapeutic Angiogenesis Products Under Development
Exhibit
2-18:
Application-Specific Carotid Stenting Systems in U.S. Clinical Trials
Exhibit
2-19: EMBOL-X™
Exhibit
2-20: FilterWire
Exhibit
2-21: Participants in the Emerging Percutaneous Embolic Containment
System Market
Exhibit
2-22 Ancure System
Exhibit
2-23: Lifepath AAA Graft
Exhibit
2-24: Model of Anaconda
Exhibit
2-25:
AAA Endovascular Repair Systems Currently on the Market and in
Advanced Trials
Exhibit
2-26: Vasoseal ES
Exhibit
2-27: Duett Balloon Catheter
Exhibit
2-28: Vascular Puncture Closure Device on the U.S. Market and Under
Development
Exhibit
3-1: Novel Cardiovascular Therapeutic Modalities, Procedure Volume
Forecast, 1999-2010
Exhibit
3-2: Novel Cardiovascular Therapy Systems, Market Forecast, 1999-2010
($ mil)
Exhibit
3-3: TMR/PTMR Patient Caseloads and Procedure Volumes, 1999-2010
(#000)
Exhibit
3-4: U.S. Markets for TMR & PTMR Disposable Kit Products,
1999-2010
Exhibit
3-5: Estimated Market Shares of the U.S. Suppliers of TMR Products,
1999
Exhibit
3-6: Projected Dynamics of Coronary Photoangioplasty Procedures
Exhibit
3-7: Emerging U.S. Market for Photoangioplasty Agents
Exhibit
3-8: Projected Dynamics of Coronary Angiogenesis Procedures
Exhibit
3-9: Emerging U.S. Market for Therapeutic Angiogenesis Agents
Exhibit
3-10: Projected Utilization Pattern of Embolic Containment Systems
Exhibit
3-11: Emerging U.S. Market for Embolic Containment Systems
Exhibit
3-12: Carotid Artery Stenosis Patient Caseloads and Procedure Volumes,
1999-2010 (#000)
