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Abbott Laboratories
Boston Scientific Corporation
C.R. Bard, Inc.
Cook Group
Edwards Lifesciences Corporation
Endologix, Inc
ev3, Inc
Guidant Corporation
Johnson & Johnson (Cordis)
Medtronic, Inc
Vascular Architects, Inc
W.L. Gore & Associates
EXECUTIVE SUMMARY
Overview of Peripheral Vascular Disease
Role of Peripheral Vascular Stenting
Stent Technology
Peripheral Vascular Stenting Procedures
Peripheral Vascular Stent Markets
Supplier Shares
Summary Exhibit 1: Overview of Peripheral Vascular Disease
Summary Exhibit 2: Overview of Peripheral Stenting Applications
Summary Exhibit 3: Major Arteries and Veins of the Body
Summary Exhibit 4: Properties of the Ideal Peripheral Vascular Stent
Summary Exhibit 5: Overview of Developments in Stent Surface Modification
Summary Exhibit 6: U.S. Peripheral Vascular Stenting Procedures by Segment, 2001-2008
Summary Exhibit 7: U.S. Market for Peripheral Vascular Stents by Segment, 2001-2008
Summary Exhibit 8: Peripheral Vascular Stents, Supplier Shares, 2002
1.0 STENT TECHNOLOGY
1.1 Stent Materials
1.1.1 Metal Stents
1.1.1.1 Materials
1.1.1.1.1 Stainless Steel
1.1.1.1.2 Cobalt Alloys
1.1.1.1.3 Nitinol
1.1.1.2 Metal Stents and MRI Imaging
1.1.1.3 Material Developments
1.1.2 Standard Polymers
1.1.3 Biodegradable Polymers
1.1.3.1 Materials
1.1.3.2 Biocompatibility
1.2 Stent Design
1.2.1 Balloon-Expandable versus Self-Expanding
1.2.2 Manufacturing Methods
1.2.3 Configurations
1.3 Surface Modifications
1.3.1 Radiopaque Surface Modifications
1.3.2 Biocompatibility Coatings
1.3.3 Therapeutic Coatings
1.3.4 Stent Coverings/Linings
1.4 Stent Testing
Exhibit 1-1: Performance Requirements of Biomedical Stent Implants
Exhibit 1-2: Properties of the Ideal Peripheral Vascular Stent
Exhibit 1-3: Overview of Principal Stent Materials
Exhibit 1-4: Metal Stent Materials
Exhibit 1-5: Selected Polymer Materials Used in Stents
Exhibit 1-6: Comparison of Two Major Metal Stent Designs
Exhibit 1-7: Comparison of Stent Designs
Exhibit 1-8: Overview of Developments in Stent Surface Modification
2.0 PERIPHERAL VASCULAR STENT PRODUCTS AND SUPPLIERS
2.1 Regulatory Issues
2.2 Products and Suppliers
2.2.1 Abbott Vascular Devices
2.2.1.1 Balloon Expandable Stents
2.2.2.2 Self-Expanding Stents
2.2.2 Angiodynamics
2.2.3 Bard Peripheral Vascular
2.2.4 Boston Scientific
2.2.4.1 Balloon Expandable Stents
2.2.4.1.1 NIR
2.2.4.1.2 Express
2.2.4.2 Self-Expanding Stents
2.2.4.2.1 Wallstent
2.2.4.2.2 Neuroform (Smart Therapeutics)
2.2.4.2.3 NexStent (EndoTex Interventional Systems)
2.2.4.2.4 Symphony (NMT Medical)
2.2.4.2.5 Sentinol
2.2.5 Cook
2.2.6 Cordis Endovascular
2.2.6.1 Balloon Expandable Stents
2.2.6.2 Self-Expanding Stents
2.2.7 Edwards Lifesciences
2.2.8 ev3 (IntraTherapeutics)
2.2.8.1 Balloon Expandable Stents
2.2.8.1.1 IntraStent
2.2.8.1.2 IntraStent DoubleStrut
2.2.8.2 Self-Expanding Stents
2.2.8.2.1 IntraCoil
2.2.8.2.2 Protégé
2.2.9 Guidant
2.2.9.1 Balloon Expandable Stents
2.2.9.2 Self-Expanding Stents
2.2.10 Medinol
2.2.11 Medtronic Vascular
2.2.11.1 Balloon Expandable Stents
2.2.11.2 Self-Expanding Stents
2.2.12 Vascular Architects
2.3 Emerging Product Trends
2.3.1 Drug Eluting Stents
2.3.2 Stent-Grafts (Covered Stents)
2.3.2.1 Abbott Vascular Devices
2.3.2.2 Boston Scientific
2.3.2.3 CardioVasc
2.3.2.4 Design & Performance
2.3.2.5 Edwards Lifesciences
2.3.2.6 W.L. Gore & Associates
2.3.3 Bifurcation Stents
2.4 Competitive Analysis
Exhibit 2-1: Selected Balloon Expandable Peripheral Vascular Stent Products and Suppliers, 2003
Exhibit 2-2: Selected Balloon Expandable Peripheral Vascular Stents, 2003
Exhibit 2-3: Selected Self-Expanding Peripheral Vascular Stent Products and Suppliers, 2003
Exhibit 2-4: Selected Self-Expanding Peripheral Vascular Stents, 2003
Exhibit 2-5: Overview of Emerging Trends in Peripheral Vascular Stents
Exhibit 2-6: Selected Drug Eluting Stent Programs
Exhibit 2-7: Selected Stent-Graft Products and Suppliers
Exhibit 2-8: Selected Stent-Grafts
Exhibit 2-9: Selected Bifurcation Stent Programs
Exhibit 2-10: Peripheral Vascular Stent Product Market, 2001-2008
Exhibit 2-11: Balloon Expandable versus Self-Expanding Stents, 2002 & 2008
Exhibit 2-12: Peripheral Vascular Stents, Market Shares by Segment, 2002
3.0 STENTING IN THE MANAGEMENT OF STROKE
3.1 Stroke Etiology
3.2 Types and Causes
3.3 Diagnosis
3.4 Stroke Intervention
3.4.1 Carotid Endarterectomy
3.4.1.1 Procedures.
3.4.1.2 Indications and Clinical Outcomes
3.4.2 Carotid Artery Stenting
3.4.2.1 Procedure
3.4.2.2 Specialties Performing
3.4.2.3 Indications and Patient Selection
3.4.2.4 Clinical Studies and Outcomes
3.4.3 Intracranial Stenting
3.4.3.1 Stenting for Intracranial Atherosclerosis
3.4.3.2 Intracranial (Cerebral) Aneurysms
3.5 Products and Suppliers
3.5.1 Carotid Artery Stents
3.5.2 Embolic Protection Devices
3.5.3 Intracranial Stents
3.6 Procedure Forecasts
3.6.1 Carotid Artery Stenting Procedures
3.6.2 Intracranial Stenting Procedures
3.7 Market Analysis
3.7.1 Carotid Artery Stents
3.7.2 Embolic Protection Devices
3.7.3 Intracranial Stents
Exhibit 3-1: Overview of Stroke in the U.S.
Exhibit 3-2: Carotid Artery Stenting: Indications and Contraindications
Exhibit 3-3: Overview of Completed Randomized Carotid Stent Clinical Studies, 2003
Exhibit 3-4: Overview of Ongoing Carotid Stent Clinical Trials, 2003
Exhibit 3-5: Characteristics of Ideal Carotid Artery Stent
Exhibit 3-6: Selected Carotid Artery Stent Products and Suppliers, 2003
Exhibit 3-7: Selected Carotid Artery Stents, 2003
Exhibit 3-8: Comparison of Embolic Protection Designs
Exhibit 3-9: Selected Embolic Protection Products and Suppliers, 2003
Exhibit 3-10: Selected Embolic Protection Devices
Exhibit 3-11: Selected Intracranial Stent Programs, 2003
Exhibit 3-12: Carotid Artery Stenting, Procedure Forecast, 2001-2008
Exhibit 3-13: Carotid Artery Stent Market, 2001-2008
4.0 RENAL ARTERY STENTING
4.1 Renal Artery Stenosis
4.1.1 Diagnosis
4.1.2 Treatment Options
4.1.2.1 Surgical Renal Revascularization
4.1.2.2 Percutaneous Transluminal Renal Angioplasty
4.1.2.3 Percutaneous Transluminal Stent Placement
4.1.3 Clinical Outcomes
4.2 Products and Suppliers
4.3 Procedure Forecast
4.4 Market Analysis
Exhibit 4-1: Current Practice Guidelines for Renal Angiography
Exhibit 4-2: Current Treatment Options for Renal Artery Stenosis
Exhibit 4-3: Current Indications for Renal Angioplasty
Exhibit 4-4: Renal Artery Stenting Indications and Contraindications
Exhibit 4-5: Selected Renal Artery Stents, 2003
Exhibit 4-6: Renal Artery Stenting, Procedure Forecast, 2001-2008
Exhibit 4-7: Renal Artery Stents, Market Forecast, 2001-2008
5.0 STENTING IN PVD OF THE LOWER EXTREMITIES
5.1 Disease Background
5.1.1 Diagnosis
5.1.2 Treatment
5.2 Iliac Artery Stenting
5.2.1 TASC Recommendations
5.2.2 Clinical Outcomes
5.2.3 Products and Suppliers
5.2.4 Procedure Forecasts
5.2.5 Market Analysis
5.3 Femoropopliteal Stenting
5.3.1 Indications
5.3.2 Clinical Outcomes
5.3.3 Products and Suppliers
5.3.4 Procedure Forecasts
5.3.5 Market Analysis
5.4 Infrapopliteal Stenting
Exhibit 5-1: TASC Morphological Stratification of Iliac Lesions and Treatment Recommendations
Exhibit 5-2: Selected Iliac Artery Stents, 2003
Exhibit 5-3: Iliac Artery Stenting, Procedure Forecast, 2001-2008
Exhibit 5-4: Iliac Artery Stents, Market Forecast, 2001-2008
Exhibit 5-5: TASC Morphological Stratification of Femoropopliteal Lesions and Treatment Recommendations
Exhibit 5-6: Selected Clinical Studies Comparing Femoropopliteal PTA and Stenting
Exhibit 5-7: Selected Outcomes of Femoropopliteal Stenting Using Next Generation Technologies
Exhibit 5-8: Selected Femoropopliteal Stent Products and Suppliers, 2003
Exhibit 5-9: Femoropopliteal Artery Stenting, Procedure Forecast, 2001-2008
Exhibit 5-10: Femoropopliteal Stents, Market Forecast, 2001-2008
Exhibit 5-11: Total Market for Lower Extremity Peripheral Vascular Stents, 2001-2008
6.0 OTHER PERIPHERAL VASCULAR STENTING APPLICATIONS
6.1 Transjugular Intrahepatic Portosystemic Shunts (TIPS)
6.1.1 Variceal Bleeding
6.1.1.1 Treatment Options
6.1.1.2 Decompression Shunt Procedures
6.1.2 TIPS Technique
6.1.3 Clinical Results
6.1.4 TIPS Products
6.1.5 Procedure Forecasts
6.1.6 Market Analysis
6.2 Subclavian Artery Stenting
6.2.1 Subclavian Stenting Technique
6.2.2 Clinical Experience
6.2.3 Stent Design
6.2.4 Products
6.3 Other Venous Stenting
6.3.1 Clinical Experience
6.3.2 Products
6.3.3 Procedures
Exhibit 6-1: Overview of Other Peripheral Vascular Stenting Applications
Exhibit 6-2: Transjugular Intrahepatic Portosystemic Shunts (TIPS), Procedure Forecast, 2001-2008
Exhibit 6-3: Transjugular Intrahepatic Portosystemic Shunt (TIPS) Stents, Market Forecast, 2001-2008
Exhibit 6-4: Selected Outcomes of Subclavian Stenting
Exhibit 6-5: Selected Outcomes of Central Venous Stenting
7.0 ENDOVASCULAR AORTIC STENT-GRAFTS
7.1 AAA Diagnosis
7.2 AAA Treatments
7.2.1 Watchful Waiting
7.2.2 Open Surgical Repair
7.2.3 Endovascular Stent-Graft Placement
7.2.3.1 Patient Selection
7.2.3.2 Stent-Graft Designs
7.2.3.3 Complications
7.2.3.4 Clinical Experience
7.3 Stent-Grafting of the Thoracic Aorta
7.3.1 Thoracic Artery Aneurysm
7.3.2 Acute Aortic Dissection
7.3.3 Stent-Graft Design
7.3.4 Clinical Experience
7.4 Products and Suppliers
7.4.1 Boston Scientific
7.4.2 Cook
7.4.3 Cordis
7.4.3.1 Quantum LP
7.4.3.2 Fortron
7.4.4 Edwards Lifesciences
7.4.5 Endologix
7.4.6 Endomed
7.4.7 Guidant
7.4.8 Implant Sciences/CardioTech International
7.4.9 Lombard Medical
7.4.10 Medtronic Vascular
7.4.10.1 AneuRx
7.4.10.2 Talent
7.4.11 TriVascular
7.4.12 Vascutek (Terumo)
7.4.13 W.L. Gore & Associates
7.5 Procedure Forecasts
7.6 Market Analysis
Exhibit 7-1: Treatment Options for Abdominal Aortic Aneurysms
Exhibit 7-2: Risk of AAA Rupture by Aneurysm Size
Exhibit 7-3: Overview of Stent-Graft Design Characteristics
Exhibit 7-4: Selected Clinical Outcomes of Endovascular AAA Repair
Exhibit 7-5: Selected Clinical Outcomes of Endovascular Thoracic Aortic Repair
Exhibit 7-6: Selected Endovascular Aortic Stent-Graft Products and Suppliers, 2003
Exhibit 7-7: Selected Endovascular Aortic Stent-Grafts
Exhibit 7-8: Market Drivers and Limiters of Endovascular Aortic Repair
Exhibit 7-9: Endovascular Aortic Repairs, Procedure Forecast, 2001-2008
Exhibit 7-10: Endovascular Aortic Stent-Graft Systems, Market Forecast, 2001-2008
Exhibit 7-11: AAA Stent-Graft Systems, Supplier Shares, 2001-2003
8.0 COMPANY PROFILES
8.1 Abbott Laboratories
8.2 C.R. Bard, Inc.
8.3 Boston Scientific Corporation
8.4 Cook Group
8.5 Edwards Lifesciences Corporation
8.6 Endologix, Inc
8.7 ev3, Inc
8.8 Guidant Corporation
8.9 Johnson & Johnson (Cordis)
8.10 Medtronic, Inc
8.11 Vascular Architects, Inc
8.12 W.L. Gore & Associates